Pub Date : 2024-09-20DOI: 10.1186/s13063-024-08462-6
Sabine Britting, Robert Kob, Anja Görlitz, Cornel C Sieber, Ellen Freiberger, Nicolas Rohleder
Background: Maintenance of physical function, mobility, and independent living are important goals for older adults. However, concerns about falling (CaF) play a central role in the vicious cycle of CaF, inflammation, loss of muscle mass, and decreasing physical function ultimately resulting in negative health outcomes. CaF, like other states of chronic stress and anxiety, can be considered as enduring adverse stimuli affecting the stress systems and the inflammatory system. Therefore, the aim of this study is to investigate whether a reduction of CaF leads to a reduction of stress and therefore possibly reduces chronic low-grade inflammation. Understanding the role and directionality of the effects of inflammation on CaF increases our understanding of age-related loss of mobility and physical function.
Methods: In this study, community-dwelling older adults, aged 70 years and older, will be randomly assigned to either a 4-month, multi-component intervention with exercise training and cognitive-behavioral components or to a sham control group with light stretching exercises, cognitive training, and educational health lectures. For the operationalization of specific CaF, the Falls Efficacy Scale-International will be used. Stress and related psychological symptoms will be monitored using established self-reports and by measuring salivary cortisol. Concentrations of C-reactive protein, interleukin 6, interleukin 10, and tumor-necrosis-factor-alpha, as well as gene expression of selected inflammatory transcripts, will be used as surrogate parameters of the inflammatory status at baseline, after the 4-month intervention and 8-month follow-up.
Discussion: This study will be the first to test whether CaF are related with stress system activity or reactivity or with markers of inflammation in the context of a multi-component intervention with exercise training and cognitive-behavioral components addressing CaF. The reduction of specific CaF or general psychological symptoms should reverse alterations in stress systems, and / or slow down low-grade inflammation. Changes in activity, as well as psychological and biological pathways leading from CaF to muscle loss will be measured, to disentangle the individual contribution to sarcopenia, and to provide an additional pathway to break or slow-down the vicious cycle of CaF and sarcopenia.
Trial registration: German Clinical Trials Register (DRKS): DRKS00029171 . Registered 22 July 2022.
{"title":"Chronic stress and functional health in older adults with concerns about falling: a study protocol of a randomized controlled trial with multicomponent exercise intervention (FEARFALL).","authors":"Sabine Britting, Robert Kob, Anja Görlitz, Cornel C Sieber, Ellen Freiberger, Nicolas Rohleder","doi":"10.1186/s13063-024-08462-6","DOIUrl":"https://doi.org/10.1186/s13063-024-08462-6","url":null,"abstract":"<p><strong>Background: </strong>Maintenance of physical function, mobility, and independent living are important goals for older adults. However, concerns about falling (CaF) play a central role in the vicious cycle of CaF, inflammation, loss of muscle mass, and decreasing physical function ultimately resulting in negative health outcomes. CaF, like other states of chronic stress and anxiety, can be considered as enduring adverse stimuli affecting the stress systems and the inflammatory system. Therefore, the aim of this study is to investigate whether a reduction of CaF leads to a reduction of stress and therefore possibly reduces chronic low-grade inflammation. Understanding the role and directionality of the effects of inflammation on CaF increases our understanding of age-related loss of mobility and physical function.</p><p><strong>Methods: </strong>In this study, community-dwelling older adults, aged 70 years and older, will be randomly assigned to either a 4-month, multi-component intervention with exercise training and cognitive-behavioral components or to a sham control group with light stretching exercises, cognitive training, and educational health lectures. For the operationalization of specific CaF, the Falls Efficacy Scale-International will be used. Stress and related psychological symptoms will be monitored using established self-reports and by measuring salivary cortisol. Concentrations of C-reactive protein, interleukin 6, interleukin 10, and tumor-necrosis-factor-alpha, as well as gene expression of selected inflammatory transcripts, will be used as surrogate parameters of the inflammatory status at baseline, after the 4-month intervention and 8-month follow-up.</p><p><strong>Discussion: </strong>This study will be the first to test whether CaF are related with stress system activity or reactivity or with markers of inflammation in the context of a multi-component intervention with exercise training and cognitive-behavioral components addressing CaF. The reduction of specific CaF or general psychological symptoms should reverse alterations in stress systems, and / or slow down low-grade inflammation. Changes in activity, as well as psychological and biological pathways leading from CaF to muscle loss will be measured, to disentangle the individual contribution to sarcopenia, and to provide an additional pathway to break or slow-down the vicious cycle of CaF and sarcopenia.</p><p><strong>Trial registration: </strong>German Clinical Trials Register (DRKS): DRKS00029171 . Registered 22 July 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11414122/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-19DOI: 10.1186/s13063-024-08459-1
D S N'Diaye, S Frison, M Ba, M L Lê, A E Cabo, F Siroma, A Devort, C MacLeod, J Lapègue, M Seye, A B Traoré, T Cerveau, D Léger, K Gallandat, Y Gnokane, A Vargas Brizuela, S Stern, L Braun, O Cumming
Introduction: High-quality evidence is crucial for guiding effective humanitarian responses, yet conducting rigorous research, particularly randomised controlled trials, in humanitarian crises remains challenging. The TISA ("traitement intégré de la sous-nutrition aiguë") trial aimed to evaluate the impact of a Water, Sanitation and Hygiene (WASH) intervention on the standard national treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6-59 months. Implemented in two northern Senegalese regions from December 22, 2021, to February 20, 2023, the trial faced numerous challenges, which this paper explores along with the lessons learned.
Methods: The study utilised trial documentation, including field reports, meeting minutes, training plans, operational monitoring data and funding proposals, to retrace the trial timeline, identify challenges and outline implemented solutions. Contributions from all TISA key staff-current and former, field-based and headquarters-were essential for collecting and interpreting information. Challenges were categorised as internal (within the TISA consortium) or external (broader contextual issues).
Results: The TISA trial, executed by a consortium of academic, operational, and community stakeholders, enrolled over 2000 children with uncomplicated SAM across 86 treatment posts in a 28,000 km2 area. The control group received standard outpatient SAM care, while the intervention group also received a WASH kit and hygiene promotion. Initially planned to start in April 2019 for 12 months, the trial faced a 30-month delay and was extended to 27 months due to challenges like the COVID-19 pandemic, national strikes, health system integration issues and weather-related disruptions. Internal challenges included logistics, staffing, data management, funding and aligning diverse stakeholder priorities.
Discussion and conclusion: Despite these obstacles, the trial concluded successfully, underscoring the importance of tailored monitoring, open communication, transparency and community involvement. Producing high-quality evidence in humanitarian contexts demands extensive preparation and strong coordination among local and international researchers, practitioners, communities, decision-makers and funders from the study's inception.
{"title":"Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial.","authors":"D S N'Diaye, S Frison, M Ba, M L Lê, A E Cabo, F Siroma, A Devort, C MacLeod, J Lapègue, M Seye, A B Traoré, T Cerveau, D Léger, K Gallandat, Y Gnokane, A Vargas Brizuela, S Stern, L Braun, O Cumming","doi":"10.1186/s13063-024-08459-1","DOIUrl":"https://doi.org/10.1186/s13063-024-08459-1","url":null,"abstract":"<p><strong>Introduction: </strong>High-quality evidence is crucial for guiding effective humanitarian responses, yet conducting rigorous research, particularly randomised controlled trials, in humanitarian crises remains challenging. The TISA (\"traitement intégré de la sous-nutrition aiguë\") trial aimed to evaluate the impact of a Water, Sanitation and Hygiene (WASH) intervention on the standard national treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6-59 months. Implemented in two northern Senegalese regions from December 22, 2021, to February 20, 2023, the trial faced numerous challenges, which this paper explores along with the lessons learned.</p><p><strong>Methods: </strong>The study utilised trial documentation, including field reports, meeting minutes, training plans, operational monitoring data and funding proposals, to retrace the trial timeline, identify challenges and outline implemented solutions. Contributions from all TISA key staff-current and former, field-based and headquarters-were essential for collecting and interpreting information. Challenges were categorised as internal (within the TISA consortium) or external (broader contextual issues).</p><p><strong>Results: </strong>The TISA trial, executed by a consortium of academic, operational, and community stakeholders, enrolled over 2000 children with uncomplicated SAM across 86 treatment posts in a 28,000 km<sup>2</sup> area. The control group received standard outpatient SAM care, while the intervention group also received a WASH kit and hygiene promotion. Initially planned to start in April 2019 for 12 months, the trial faced a 30-month delay and was extended to 27 months due to challenges like the COVID-19 pandemic, national strikes, health system integration issues and weather-related disruptions. Internal challenges included logistics, staffing, data management, funding and aligning diverse stakeholder priorities.</p><p><strong>Discussion and conclusion: </strong>Despite these obstacles, the trial concluded successfully, underscoring the importance of tailored monitoring, open communication, transparency and community involvement. Producing high-quality evidence in humanitarian contexts demands extensive preparation and strong coordination among local and international researchers, practitioners, communities, decision-makers and funders from the study's inception.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov NCT04667767 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11414177/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-19DOI: 10.1186/s13063-024-08461-7
Katie O'Hearn, Kusum Menon, Lisa Albrecht, Karin Amrein, Philip Britz-McKibbin, Florence Cayouette, Karen Choong, Jennifer Ruth Foster, Dean A Fergusson, Alejandro Floh, Patricia Fontela, Pavel Geier, Elaine Gilfoyle, Gonzalo Garcia Guerra, Anna Gunz, Erick Helmeczi, Ali Khamessan, Ari R Joffe, Laurie Lee, Lauralyn McIntyre, Srinivas Murthy, Simon J Parsons, Tim Ramsay, Lindsay Ryerson, Marisa Tucci, Dayre McNally
Background: The rate of vitamin D deficiency (VDD) in critically ill children worldwide has been estimated at 50%. These children are at risk of multiple organ dysfunction, chronic morbidity, and decreased health related quality of life (HRQL). Pediatric and adult ICU clinical trials suggest that VDD is associated with worse clinical outcomes, although data from supplementation trials are limited and inconclusive. Our group's phase II multicenter dose evaluation pilot study established the efficacy and safety of an enteral weight-based cholecalciferol loading dose to rapidly restore vitamin D levels in critically ill children.
Methods: Our aim is to evaluate the impact of this dosing regimen on clinical outcomes. VITdALIZE-KIDS is a pragmatic, phase III, multicenter, double-blind RCT aiming to randomize 766 critically ill children from Canadian PICUs. Participants are randomized using a 1:1 scheme to receive a single dose at enrollment of enteral cholecalciferol (10,000 IU/kg, max 400,000 IU) or placebo. Eligibility criteria include critically ill children aged newborn (> 37 weeks corrected gestational age) to < 18 years who have blood total 25-hydroxyvitamin D < 50 nmol/L. The primary objective is to determine if rapid normalization of vitamin D status improves HRQL at 28 days following enrollment. The secondary objective is to evaluate the impact of rapid normalization of vitamin D status on multiple organ dysfunction. The study includes additional tertiary outcomes including functional status, HRQL and mortality at hospital discharge and 90 days, PICU and hospital length of stay, and adverse events related to vitamin D toxicity. Additionally, we are performing comprehensive vitamin D speciation and non-targeted metabolite profiling as part of a sub-study for the first 100 participants from whom an enrollment and at least one post-intervention blood and urine sample were obtained.
Discussion: The VITdALIZE-KIDS trial is the first phase III, multicenter trial to evaluate whether rapid normalization of vitamin D status could represent a simple, inexpensive, and safe means of improving outcomes following pediatric critical illness. Recruitment was initiated in June 2019 and is expected to continue to March 2026.
Trial registration: Clinicaltrials.gov, NCT03742505. Study first submitted on November 12, 2018 https://clinicaltrials.gov/study/NCT03742505.
背景：据估计，全球重症儿童的维生素 D 缺乏率（VDD）为 50%。这些儿童有可能出现多器官功能障碍、慢性发病和与健康相关的生活质量下降（HRQL）。儿童和成人重症监护室的临床试验表明，VDD 与较差的临床预后有关，但补充试验的数据有限，且尚无定论。我们小组的 II 期多中心剂量评估试验研究确定了基于体重的肠道胆钙化醇负荷剂量对快速恢复重症儿童维生素 D 水平的有效性和安全性：我们的目的是评估这种给药方案对临床结果的影响。VITdALIZE-KIDS 是一项务实的 III 期多中心双盲 RCT 研究，旨在对来自加拿大 PICU 的 766 名重症儿童进行随机分组。参与者按照 1:1 的比例随机分配，在入院时接受单剂量肠内胆钙醇（10,000 IU/kg，最大剂量 400,000 IU）或安慰剂。资格标准包括新生儿（胎龄大于 37 周）至讨论期的重症患儿：VITdALIZE-KIDS试验是首个III期多中心试验，旨在评估快速使维生素D状态正常化是否是一种简单、廉价、安全的改善儿科危重病后预后的方法。招募工作于2019年6月启动，预计将持续到2026年3月：Clinicaltrials.gov, NCT03742505.研究首次提交于2018年11月12日https://clinicaltrials.gov/study/NCT03742505。
{"title":"Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial.","authors":"Katie O'Hearn, Kusum Menon, Lisa Albrecht, Karin Amrein, Philip Britz-McKibbin, Florence Cayouette, Karen Choong, Jennifer Ruth Foster, Dean A Fergusson, Alejandro Floh, Patricia Fontela, Pavel Geier, Elaine Gilfoyle, Gonzalo Garcia Guerra, Anna Gunz, Erick Helmeczi, Ali Khamessan, Ari R Joffe, Laurie Lee, Lauralyn McIntyre, Srinivas Murthy, Simon J Parsons, Tim Ramsay, Lindsay Ryerson, Marisa Tucci, Dayre McNally","doi":"10.1186/s13063-024-08461-7","DOIUrl":"https://doi.org/10.1186/s13063-024-08461-7","url":null,"abstract":"<p><strong>Background: </strong>The rate of vitamin D deficiency (VDD) in critically ill children worldwide has been estimated at 50%. These children are at risk of multiple organ dysfunction, chronic morbidity, and decreased health related quality of life (HRQL). Pediatric and adult ICU clinical trials suggest that VDD is associated with worse clinical outcomes, although data from supplementation trials are limited and inconclusive. Our group's phase II multicenter dose evaluation pilot study established the efficacy and safety of an enteral weight-based cholecalciferol loading dose to rapidly restore vitamin D levels in critically ill children.</p><p><strong>Methods: </strong>Our aim is to evaluate the impact of this dosing regimen on clinical outcomes. VITdALIZE-KIDS is a pragmatic, phase III, multicenter, double-blind RCT aiming to randomize 766 critically ill children from Canadian PICUs. Participants are randomized using a 1:1 scheme to receive a single dose at enrollment of enteral cholecalciferol (10,000 IU/kg, max 400,000 IU) or placebo. Eligibility criteria include critically ill children aged newborn (> 37 weeks corrected gestational age) to < 18 years who have blood total 25-hydroxyvitamin D < 50 nmol/L. The primary objective is to determine if rapid normalization of vitamin D status improves HRQL at 28 days following enrollment. The secondary objective is to evaluate the impact of rapid normalization of vitamin D status on multiple organ dysfunction. The study includes additional tertiary outcomes including functional status, HRQL and mortality at hospital discharge and 90 days, PICU and hospital length of stay, and adverse events related to vitamin D toxicity. Additionally, we are performing comprehensive vitamin D speciation and non-targeted metabolite profiling as part of a sub-study for the first 100 participants from whom an enrollment and at least one post-intervention blood and urine sample were obtained.</p><p><strong>Discussion: </strong>The VITdALIZE-KIDS trial is the first phase III, multicenter trial to evaluate whether rapid normalization of vitamin D status could represent a simple, inexpensive, and safe means of improving outcomes following pediatric critical illness. Recruitment was initiated in June 2019 and is expected to continue to March 2026.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT03742505. Study first submitted on November 12, 2018 https://clinicaltrials.gov/study/NCT03742505.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11414195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In addition to Helicobacter pylori (H. pylori) infection eradication, some medications, including aspirin, metformin, and statins, have been suggested to have protective effects against gastric cancer (GC) development in observational studies. We launched the Ardabil gastric cancer randomized placebo-controlled prevention trial (AGCPT) to evaluate the effectiveness of long-term low-dose aspirin use for the prevention of development and mortality of GC after H. pylori eradication. AGCPT is a prospective population-based double-blind, randomized clinical trial. The study sample was targeted at 21,000 participants aged from 35 to 70 years old, both sexes, in Ardabil, a province in northwest Iran with relatively high rates of GC incidence and mortality. All eligible participants were initially tested for H. pylori infection using a H. pylori stool antigen test. Participants with positive tests undergo H. pylori eradication by standard treatment regimens. All participants with a negative test and those with a positive test with a subsequent confirmed H. pylori eradication test were entered into the intervention phase. In the intervention phase, participants were allocated randomly into either the treatment (daily oral consumption of 81 mg enteric-coated aspirin tablets) arm or the control (placebo) arm using permuted balanced blocks. Subjects will be followed for an average period of 10 years to evaluate the incidence and mortality rates of GC. In addition to preventing other diseases like cardiovascular events, aspirin may prevent GC incidence and mortality. AGCPT will investigate the difference between the two study arms in the proportion of the cumulative incidence and mortality rates of GC. The study’s results may help policymakers and researchers update the strategies for GC prevention. This trial with the registry name of “The effect of Low-dose Aspirin in the Prevention of Gastric Cancer” was registered in the Iranian Registry of Clinical Trials, IRCT.ir, under the identifier IRCT201105082032N3. Registered on April 21, 2017.
{"title":"Effectiveness of long-term low-dose aspirin in the prevention of gastric cancer after Helicobacter pylori eradication: study design and rationale of Ardabil gastric cancer randomized placebo-controlled prevention trial (AGCPT)","authors":"Farhad Pourfarzi, Mohammad-Mahdi Rashidi, Abbas Yazdanbod, Ali Nemati, Hadi Peeri Dogaheh, Elnaz Faghfuri, Fateme Gorgani, Saied Hosseini-Asl, Bijan Zamani, Sanaz Pourfarzi, Arash Etemadi, Fateme Shafighian, Negar Rezaei, Hossein Poustchi, Reza Malekzadeh, Alireza Sadjadi","doi":"10.1186/s13063-024-08455-5","DOIUrl":"https://doi.org/10.1186/s13063-024-08455-5","url":null,"abstract":"In addition to Helicobacter pylori (H. pylori) infection eradication, some medications, including aspirin, metformin, and statins, have been suggested to have protective effects against gastric cancer (GC) development in observational studies. We launched the Ardabil gastric cancer randomized placebo-controlled prevention trial (AGCPT) to evaluate the effectiveness of long-term low-dose aspirin use for the prevention of development and mortality of GC after H. pylori eradication. AGCPT is a prospective population-based double-blind, randomized clinical trial. The study sample was targeted at 21,000 participants aged from 35 to 70 years old, both sexes, in Ardabil, a province in northwest Iran with relatively high rates of GC incidence and mortality. All eligible participants were initially tested for H. pylori infection using a H. pylori stool antigen test. Participants with positive tests undergo H. pylori eradication by standard treatment regimens. All participants with a negative test and those with a positive test with a subsequent confirmed H. pylori eradication test were entered into the intervention phase. In the intervention phase, participants were allocated randomly into either the treatment (daily oral consumption of 81 mg enteric-coated aspirin tablets) arm or the control (placebo) arm using permuted balanced blocks. Subjects will be followed for an average period of 10 years to evaluate the incidence and mortality rates of GC. In addition to preventing other diseases like cardiovascular events, aspirin may prevent GC incidence and mortality. AGCPT will investigate the difference between the two study arms in the proportion of the cumulative incidence and mortality rates of GC. The study’s results may help policymakers and researchers update the strategies for GC prevention. This trial with the registry name of “The effect of Low-dose Aspirin in the Prevention of Gastric Cancer” was registered in the Iranian Registry of Clinical Trials, IRCT.ir, under the identifier IRCT201105082032N3. Registered on April 21, 2017.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142267429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Numerous studies have validated the clinical effectiveness of electromagnetic pairing-associated stimulation. Building upon this foundation, we have developed a novel approach involving high-frequency magnetic paired-associated stimulation, aiming to enhance clinical applicability and potentially improve efficacy. However, the clinical effectiveness of this approach remains unclear. Our objective is to demonstrate the therapeutic efficacy of this novel approach by employing high-frequency pairing to intervene in patients experiencing motor dysfunction following a stroke. This is a single-center, single-blind, sham stimulation controlled clinical trial involving patients with upper limb motor dysfunction post-stroke. The intervention utilizes paired magnetic stimulation, combining peripheral and central magnetic stimulation, in patients with Brunnstrom stage III–V stroke lasting from 3 months to 1 year. Evaluation of patients’ upper limb motor function occurred before the intervention and after 3 weeks of intervention. Follow-up visits will be conducted after 5 weeks and 3 months of intervention. The primary outcome measure is the Action Research Arm Test, with secondary measures including the Fugl-Meyer Assessment-upper, Modified Barthel Index, modified Tardieu scale, functional near-infrared spectroscopy, and neuroelectrophysiology. The high-frequency magnetic paired associative stimulation used in this study combined high-frequency magnetic stimulation with paired stimulation, potentially facilitating both cortical excitation through high-frequency stimulation and specific circuit enhancement through paired stimulation. As dual-coil magnetic stimulation equipment becomes increasingly popular, magnetic-magnetic paired associated stimulation may offer patients improved clinical outcomes at reduced costs. Chinese Clinical Trial Registry,ChiCTR2400083363. Registered on 23 April 2024.
{"title":"High-frequency magnetic paired associated stimulation promotes motor function recovery in ischemic stroke patients: a study protocol for single-center, sham stimulation randomized controlled trials (H2MPAS)","authors":"Guangyue Zhu, Shuping Wang, Guodong Zhang, Yu Zhang, Zhexue Huang, Xiaoshun Tan, Yuhui Chen, Hui Sun, Dongsheng Xu","doi":"10.1186/s13063-024-08451-9","DOIUrl":"https://doi.org/10.1186/s13063-024-08451-9","url":null,"abstract":"Numerous studies have validated the clinical effectiveness of electromagnetic pairing-associated stimulation. Building upon this foundation, we have developed a novel approach involving high-frequency magnetic paired-associated stimulation, aiming to enhance clinical applicability and potentially improve efficacy. However, the clinical effectiveness of this approach remains unclear. Our objective is to demonstrate the therapeutic efficacy of this novel approach by employing high-frequency pairing to intervene in patients experiencing motor dysfunction following a stroke. This is a single-center, single-blind, sham stimulation controlled clinical trial involving patients with upper limb motor dysfunction post-stroke. The intervention utilizes paired magnetic stimulation, combining peripheral and central magnetic stimulation, in patients with Brunnstrom stage III–V stroke lasting from 3 months to 1 year. Evaluation of patients’ upper limb motor function occurred before the intervention and after 3 weeks of intervention. Follow-up visits will be conducted after 5 weeks and 3 months of intervention. The primary outcome measure is the Action Research Arm Test, with secondary measures including the Fugl-Meyer Assessment-upper, Modified Barthel Index, modified Tardieu scale, functional near-infrared spectroscopy, and neuroelectrophysiology. The high-frequency magnetic paired associative stimulation used in this study combined high-frequency magnetic stimulation with paired stimulation, potentially facilitating both cortical excitation through high-frequency stimulation and specific circuit enhancement through paired stimulation. As dual-coil magnetic stimulation equipment becomes increasingly popular, magnetic-magnetic paired associated stimulation may offer patients improved clinical outcomes at reduced costs. Chinese Clinical Trial Registry,ChiCTR2400083363. Registered on 23 April 2024.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142267428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rotator cuff calcific tendinitis (RCCT) is a common shoulder disease whose main symptoms include shoulder pain, limited mobility, and calcification deposits in the shoulder. Traditional treatment methods have certain limitations, so finding new treatment methods has become the focus of research. Extracorporeal shock wave (ESW) and platelet-rich plasma (PRP) treatments have attracted much attention due to their non-invasive and tissue repair-promoting properties; however, the efficacy of their combined treatment in RCCT remains unclear. This study is designed as a single-center, assessment-blind, randomized controlled clinical trial with three parallel groups. Sixty subjects will be recruited and randomly divided into the ESW group, PRP group, and ESW combined with PRP group, in a 1:1:1 ratio. The entire intervention period is 4 weeks, and the follow-up period is 4 weeks. Outcomes will be measured at baseline (T0), after 1 week of intervention (T1), after 2 weeks of intervention (T2), after 4 weeks of intervention (T3), and after an additional 4 weeks of follow-up period (T4). The primary endpoint is the VAS score. Secondary endpoints are ASES, CMS, UCLA, and the location and size of calcified areas. This study aims to evaluate the efficacy of ESW therapy combined with PRP in treating RCCT. We compare the effects of single and combined treatments to explore their impact on disease symptoms, functional improvement, and calcification regression. This provides a scientific basis for identifying more effective treatment options. ClinicalTrials.gov NCT06372600. Registered on April 17, 2024; version 1.
{"title":"Effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on rotator cuff calcific tendinitis: study protocol for a randomized controlled trial","authors":"Xiaofang Wang, Shuya Jia, Jianhui Cui, Xiali Xue, Zhiguang Tian","doi":"10.1186/s13063-024-08407-z","DOIUrl":"https://doi.org/10.1186/s13063-024-08407-z","url":null,"abstract":"Rotator cuff calcific tendinitis (RCCT) is a common shoulder disease whose main symptoms include shoulder pain, limited mobility, and calcification deposits in the shoulder. Traditional treatment methods have certain limitations, so finding new treatment methods has become the focus of research. Extracorporeal shock wave (ESW) and platelet-rich plasma (PRP) treatments have attracted much attention due to their non-invasive and tissue repair-promoting properties; however, the efficacy of their combined treatment in RCCT remains unclear. This study is designed as a single-center, assessment-blind, randomized controlled clinical trial with three parallel groups. Sixty subjects will be recruited and randomly divided into the ESW group, PRP group, and ESW combined with PRP group, in a 1:1:1 ratio. The entire intervention period is 4 weeks, and the follow-up period is 4 weeks. Outcomes will be measured at baseline (T0), after 1 week of intervention (T1), after 2 weeks of intervention (T2), after 4 weeks of intervention (T3), and after an additional 4 weeks of follow-up period (T4). The primary endpoint is the VAS score. Secondary endpoints are ASES, CMS, UCLA, and the location and size of calcified areas. This study aims to evaluate the efficacy of ESW therapy combined with PRP in treating RCCT. We compare the effects of single and combined treatments to explore their impact on disease symptoms, functional improvement, and calcification regression. This provides a scientific basis for identifying more effective treatment options. ClinicalTrials.gov NCT06372600. Registered on April 17, 2024; version 1.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142267430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-17DOI: 10.1186/s13063-024-08444-8
Katrien Nulens, Els Papy, Katrien Tartaglia, Isabelle Dehaene, Hilde Logghe, Joachim Van Keirsbilck, Frédéric Chantraine, Veronique Masson, Eva Simoens, Willem Gysemans, Liesbeth Bruckers, Sarah Lebeer, Camille Nina Allonsius, Eline Oerlemans, Deborah Steensels, Marijke Reynders, Dirk Timmerman, Roland Devlieger, Caroline Van Holsbeke
Prematurity remains one of the main causes of neonatal morbidity and mortality. Approximately two thirds of preterm births are spontaneous, i.e. secondary to preterm labour, preterm prelabour rupture of membranes (PPROM) or cervical insufficiency. Etiologically, the vaginal microbiome plays an important role in spontaneous preterm birth (sPTB). Vaginal dysbiosis and bacterial vaginosis are well-known risk factors for ascending lower genital tract infections and sPTB, while a Lactobacillus crispatus-dominated vaginal microbiome is associated with term deliveries. Synbiotics may help to achieve and/or maintain a normal, Lactobacillus-dominated vaginal microbiome. We will perform a multi-centre, double-blind, randomised, placebo-controlled trial. Women aged 18 years or older with a singleton pregnancy are eligible for inclusion at 80/7–106/7 weeks gestational age if they have one or more of the following risk factors for sPTB: previous sPTB at 240/7–356/7 weeks, prior PPROM before 360/7 weeks, or spontaneous pregnancy loss at 140/7–236/7 weeks of gestation. Exclusion criteria are multiple gestation, cervix conisation, inflammatory bowel disease, uterine anomaly, and the use of pro-/pre-/synbiotics. Patients will be randomised to oral synbiotics or placebo, starting before 11 weeks of gestation until delivery. The oral synbiotic consists of eight Lactobacillus species (including L. crispatus) and prebiotics. The primary outcome is the gestational age at delivery. Vaginal microbiome analysis once per trimester (at approximately 9, 20, and 30 weeks) and delivery will be performed using metataxonomic sequencing (16S rRNA gene) and microbial culture. Secondary outcomes include PPROM, the use of antibiotics, antenatal admission information, and neonatal outcomes. This study will evaluate the effect of oral synbiotics on the vaginal microbiome during pregnancy in a high-risk population and correlate the microbial changes with the gestational age at delivery and relevant pregnancy outcomes. ClinicalTrials.gov, NCT05966649. Registered on April 5, 2024.
{"title":"Synbiotics in patients at risk for spontaneous preterm birth: protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI)","authors":"Katrien Nulens, Els Papy, Katrien Tartaglia, Isabelle Dehaene, Hilde Logghe, Joachim Van Keirsbilck, Frédéric Chantraine, Veronique Masson, Eva Simoens, Willem Gysemans, Liesbeth Bruckers, Sarah Lebeer, Camille Nina Allonsius, Eline Oerlemans, Deborah Steensels, Marijke Reynders, Dirk Timmerman, Roland Devlieger, Caroline Van Holsbeke","doi":"10.1186/s13063-024-08444-8","DOIUrl":"https://doi.org/10.1186/s13063-024-08444-8","url":null,"abstract":"Prematurity remains one of the main causes of neonatal morbidity and mortality. Approximately two thirds of preterm births are spontaneous, i.e. secondary to preterm labour, preterm prelabour rupture of membranes (PPROM) or cervical insufficiency. Etiologically, the vaginal microbiome plays an important role in spontaneous preterm birth (sPTB). Vaginal dysbiosis and bacterial vaginosis are well-known risk factors for ascending lower genital tract infections and sPTB, while a Lactobacillus crispatus-dominated vaginal microbiome is associated with term deliveries. Synbiotics may help to achieve and/or maintain a normal, Lactobacillus-dominated vaginal microbiome. We will perform a multi-centre, double-blind, randomised, placebo-controlled trial. Women aged 18 years or older with a singleton pregnancy are eligible for inclusion at 80/7–106/7 weeks gestational age if they have one or more of the following risk factors for sPTB: previous sPTB at 240/7–356/7 weeks, prior PPROM before 360/7 weeks, or spontaneous pregnancy loss at 140/7–236/7 weeks of gestation. Exclusion criteria are multiple gestation, cervix conisation, inflammatory bowel disease, uterine anomaly, and the use of pro-/pre-/synbiotics. Patients will be randomised to oral synbiotics or placebo, starting before 11 weeks of gestation until delivery. The oral synbiotic consists of eight Lactobacillus species (including L. crispatus) and prebiotics. The primary outcome is the gestational age at delivery. Vaginal microbiome analysis once per trimester (at approximately 9, 20, and 30 weeks) and delivery will be performed using metataxonomic sequencing (16S rRNA gene) and microbial culture. Secondary outcomes include PPROM, the use of antibiotics, antenatal admission information, and neonatal outcomes. This study will evaluate the effect of oral synbiotics on the vaginal microbiome during pregnancy in a high-risk population and correlate the microbial changes with the gestational age at delivery and relevant pregnancy outcomes. ClinicalTrials.gov, NCT05966649. Registered on April 5, 2024.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142267459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-16DOI: 10.1186/s13063-024-08460-8
Lindsay Kehoe, Trevan Locke, Mark McClellan, Martin Landray, Adrian Hernandez, Sally Okun
Clinical evidence generation from and for representative populations can be improved through increased research access and ease of trial participation. To improve access and participation, a modern trial infrastructure is needed that broadens research into more routine practice. This commentary highlights current barriers, areas of advancement, and actions needed to enable continued transformation toward a modern trial infrastructure for an improved evidence generation system. The focus of this commentary is on the development of medical products (e.g., drugs, devices, biologics) and infrastructure issues within the United States, with the aim to have broader, multi-national applicability.
{"title":"Overcoming the barriers to better evidence generation from clinical trials","authors":"Lindsay Kehoe, Trevan Locke, Mark McClellan, Martin Landray, Adrian Hernandez, Sally Okun","doi":"10.1186/s13063-024-08460-8","DOIUrl":"https://doi.org/10.1186/s13063-024-08460-8","url":null,"abstract":"Clinical evidence generation from and for representative populations can be improved through increased research access and ease of trial participation. To improve access and participation, a modern trial infrastructure is needed that broadens research into more routine practice. This commentary highlights current barriers, areas of advancement, and actions needed to enable continued transformation toward a modern trial infrastructure for an improved evidence generation system. The focus of this commentary is on the development of medical products (e.g., drugs, devices, biologics) and infrastructure issues within the United States, with the aim to have broader, multi-national applicability.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142267460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-16DOI: 10.1186/s13063-024-08326-z
Pierre Huette, Mouhamed Moussa, Momar Diouf, Thomas Lefebvre, Guillaume Bayart, Mathieu Guilbart, Christophe Viart, Guillaume Haye, Stéphane Bar, Thierry Caus, Sandrine Soriot-Thomas, Sophie Boddaert, Hamza Yahia Alshatri, Paul Tarpin, Ottilie Fumery, Christophe Beyls, Hervé Dupont, Yazine Mahjoub, Emmanuel Besnier, Osama Abou-Arab
Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for the management of acute postoperative pain as part of a multimodal strategy to reduce opioid use, relieve pain, and reduce chronic pain in non-cardiac surgery. However, significant concerns arise in cardiac surgery due to the potential adverse effects of NSAID including increased bleeding and acute kidney injury (AKI). We hypothesized that NSAIDs are effective against pain and safe in the early postoperative period following cardiac surgery, taking contraindications into account. The KETOPAIN trial is a prospective, double blind, 1:1 ratio, versus placebo multicentric trial, randomizing 238 patients scheduled for cardiac surgery. Written consent will be obtained for all participants. The inclusion criterion is patients more than 18 years old undergoing for elective cardiac surgery under cardiopulmonary bypass (CPB). Patients will be allocated to the intervention (ketoprofen) group (n = 119) or the control (placebo) group (n = 119). In the intervention group, in addition to the standard treatment, patients will receive NSAIDs (ketoprofen) at a dose of 100 mg each 12 h 48 h after. The control group, in addition to the standard treatment, will receive a placebo of NSAIDs every 12 h for 48 h after surgery. An intention-to-treat analysis will be performed. The primary endpoint will be the intensity of acute postoperative pain at rest at 24 h from the end of surgery. Pain will be assessed using the numerous rating scale. The secondary endpoints will be postoperative pain on coughing during chest physiotherapy, postoperative pain until day 7, the pain trajectory between day 3 and day 7, cumulative opioid consumption within 48 h after surgery, nausea and vomiting, the occurrence of postoperative pulmonary complications within the first 7 days after surgery, neuropathic pain at 3 months, and quality of life at 3 months. NSAIDs function as non-selective, reversible inhibitors of the cyclooxygenase enzyme and play a role in a multimodal pain management approach. While there are recommendations supporting the use of NSAIDs in major non-cardiac surgery, recent guidelines do not favor their use in cardiac surgery. However, this is based on low-quality evidence. Major concerns regarding NSAID use in cardiac surgery patients are potential increase in postoperative bleeding or AKI. However, few studies support the possible use of NSAIDs without the risk of bleeding and/or AKI. Also, in a recent French survey, many anesthesiologists reported using NSAIDs in cardiac surgery. To date, no large randomized study has been conducted to evaluate the efficacy of NSAIDs in the management of postoperative pain in cardiac surgery. The expected outcome of this study is an improvement in the management of acute postoperative pain in cardiac surgery with a multimodal strategy including the use of NSAIDs. ClinicalTrials.gov NCT06381063. Registered on April 24, 2024.
{"title":"Effect of non-steroidal anti-inflammatory drugs on the management of postoperative pain after cardiac surgery: a multicenter, randomized, controlled, double-blind trial (KETOPAIN Study)","authors":"Pierre Huette, Mouhamed Moussa, Momar Diouf, Thomas Lefebvre, Guillaume Bayart, Mathieu Guilbart, Christophe Viart, Guillaume Haye, Stéphane Bar, Thierry Caus, Sandrine Soriot-Thomas, Sophie Boddaert, Hamza Yahia Alshatri, Paul Tarpin, Ottilie Fumery, Christophe Beyls, Hervé Dupont, Yazine Mahjoub, Emmanuel Besnier, Osama Abou-Arab","doi":"10.1186/s13063-024-08326-z","DOIUrl":"https://doi.org/10.1186/s13063-024-08326-z","url":null,"abstract":"Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for the management of acute postoperative pain as part of a multimodal strategy to reduce opioid use, relieve pain, and reduce chronic pain in non-cardiac surgery. However, significant concerns arise in cardiac surgery due to the potential adverse effects of NSAID including increased bleeding and acute kidney injury (AKI). We hypothesized that NSAIDs are effective against pain and safe in the early postoperative period following cardiac surgery, taking contraindications into account. The KETOPAIN trial is a prospective, double blind, 1:1 ratio, versus placebo multicentric trial, randomizing 238 patients scheduled for cardiac surgery. Written consent will be obtained for all participants. The inclusion criterion is patients more than 18 years old undergoing for elective cardiac surgery under cardiopulmonary bypass (CPB). Patients will be allocated to the intervention (ketoprofen) group (n = 119) or the control (placebo) group (n = 119). In the intervention group, in addition to the standard treatment, patients will receive NSAIDs (ketoprofen) at a dose of 100 mg each 12 h 48 h after. The control group, in addition to the standard treatment, will receive a placebo of NSAIDs every 12 h for 48 h after surgery. An intention-to-treat analysis will be performed. The primary endpoint will be the intensity of acute postoperative pain at rest at 24 h from the end of surgery. Pain will be assessed using the numerous rating scale. The secondary endpoints will be postoperative pain on coughing during chest physiotherapy, postoperative pain until day 7, the pain trajectory between day 3 and day 7, cumulative opioid consumption within 48 h after surgery, nausea and vomiting, the occurrence of postoperative pulmonary complications within the first 7 days after surgery, neuropathic pain at 3 months, and quality of life at 3 months. NSAIDs function as non-selective, reversible inhibitors of the cyclooxygenase enzyme and play a role in a multimodal pain management approach. While there are recommendations supporting the use of NSAIDs in major non-cardiac surgery, recent guidelines do not favor their use in cardiac surgery. However, this is based on low-quality evidence. Major concerns regarding NSAID use in cardiac surgery patients are potential increase in postoperative bleeding or AKI. However, few studies support the possible use of NSAIDs without the risk of bleeding and/or AKI. Also, in a recent French survey, many anesthesiologists reported using NSAIDs in cardiac surgery. To date, no large randomized study has been conducted to evaluate the efficacy of NSAIDs in the management of postoperative pain in cardiac surgery. The expected outcome of this study is an improvement in the management of acute postoperative pain in cardiac surgery with a multimodal strategy including the use of NSAIDs. ClinicalTrials.gov NCT06381063. Registered on April 24, 2024.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142267461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-13DOI: 10.1186/s13063-024-08413-1
Alberto Pilotto, Marina Barbagelata, Eleonora Lacorte, Carlo Custodero, Nicola Veronese, Valentina Maione, Wanda Morganti, Emanuele Seminerio, Paola Piscopo, Elisa Fabrizi, Patrizia Lorenzini, Elena Carbone, Pierangelo Lora Aprile, Vincenzo Solfrizzi, Mario Barbagallo, Nicola Vanacore
Multicomponent interventions based on a comprehensive geriatric assessment (CGA) could promote active aging and improve health status in older people with Noncommunicable Chronic Diseases (NCDs), but conflicting evidences are available. To evaluate the efficacy of a CGA-based multicomponent personalized preventive program (PPP) in reducing unplanned hospitalization rates during 12-month follow-up in community-dwelling older people with NCDs. In this randomized clinical trial (RCT), 1216 older adults recruited by 33 general practitioners (GPs) will be randomly allocated to intervention group (IG) or usual care control group (CG). The IG will receive a multicomponent PPP developed on the findings of the CGA-based Multidimensional Prognostic Index short-form (Brief-MPI), including structured interventions to improve functional, physical, cognitive, and nutritional status, to monitor NCDs and vaccinations, and to prevent social isolation. Participants in the CG will receive usual care. Brief-MPI, resilience, and health-related quality of life will be assessed after 6 and 12 months. Moreover, saliva samples will be collected at baseline in IG to measure biomarkers of oxidative stress, inflammatory cytokines, and oral microbiome. The CGA-based PPP might reduce unplanned hospitalization rates and potentially institutionalization rates, emergency department (ED) and unplanned GP visits, and mortality. Further outcomes explored in the IG will be the adherence to PPP, resilience, health-related quality of life, and multidimensional frailty as assessed by the Brief-MPI. Results will suggest whether the CGA-based multicomponent PPP is able to improve specific outcomes in a primary care setting. ClinicalTrials.gov; identifier: NCT06224556 ; Registered January 25, 2024.
{"title":"A multicomponent personalized prevention program in the primary care setting: a randomized clinical trial in older people with noncommunicable chronic diseases (Primacare_P3 study)","authors":"Alberto Pilotto, Marina Barbagelata, Eleonora Lacorte, Carlo Custodero, Nicola Veronese, Valentina Maione, Wanda Morganti, Emanuele Seminerio, Paola Piscopo, Elisa Fabrizi, Patrizia Lorenzini, Elena Carbone, Pierangelo Lora Aprile, Vincenzo Solfrizzi, Mario Barbagallo, Nicola Vanacore","doi":"10.1186/s13063-024-08413-1","DOIUrl":"https://doi.org/10.1186/s13063-024-08413-1","url":null,"abstract":"Multicomponent interventions based on a comprehensive geriatric assessment (CGA) could promote active aging and improve health status in older people with Noncommunicable Chronic Diseases (NCDs), but conflicting evidences are available. To evaluate the efficacy of a CGA-based multicomponent personalized preventive program (PPP) in reducing unplanned hospitalization rates during 12-month follow-up in community-dwelling older people with NCDs. In this randomized clinical trial (RCT), 1216 older adults recruited by 33 general practitioners (GPs) will be randomly allocated to intervention group (IG) or usual care control group (CG). The IG will receive a multicomponent PPP developed on the findings of the CGA-based Multidimensional Prognostic Index short-form (Brief-MPI), including structured interventions to improve functional, physical, cognitive, and nutritional status, to monitor NCDs and vaccinations, and to prevent social isolation. Participants in the CG will receive usual care. Brief-MPI, resilience, and health-related quality of life will be assessed after 6 and 12 months. Moreover, saliva samples will be collected at baseline in IG to measure biomarkers of oxidative stress, inflammatory cytokines, and oral microbiome. The CGA-based PPP might reduce unplanned hospitalization rates and potentially institutionalization rates, emergency department (ED) and unplanned GP visits, and mortality. Further outcomes explored in the IG will be the adherence to PPP, resilience, health-related quality of life, and multidimensional frailty as assessed by the Brief-MPI. Results will suggest whether the CGA-based multicomponent PPP is able to improve specific outcomes in a primary care setting. ClinicalTrials.gov; identifier: NCT06224556 ; Registered January 25, 2024.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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