Jesus Orellana-Jaén , Matilde Mora-Fernández , Luis Carrasco-Páez
{"title":"运动和认知训练计划对乳腺癌幸存者执行功能和与肌肉-大脑串扰相关的不同生物标志物的影响：三臂随机对照 BRAINonFIT 研究方案","authors":"Jesus Orellana-Jaén , Matilde Mora-Fernández , Luis Carrasco-Páez","doi":"10.1016/j.cct.2024.107672","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Cancer-related cognitive impairment (CRCI) is a significant but often neglected issue for breast cancer survivors that reduces their quality of life. Physical exercise and cognitive training have emerged as promising strategies for CRCI; however, evidence regarding its effectiveness is still unknown. A recently developed motor-cognitive training (dual-tasks) is proposed to examine its efficacy on executive function, physical fitness, emotional symptomatology, and important muscle-brain crosstalk biomarkers.</p></div><div><h3>Methods</h3><p>The BRAINonFIT study is a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks). Breast cancer survivors (stage I-IIIA) with completed chemotherapy are recruited from QuirónSalud Hospital in Seville. Principal outcomes are executive functions, measured by the Trail Making Test, Stroop and Digit Span Backwards; physical fitness, assessed by muscle strength, cardiorespiratory fitness, and body composition; and several muscle-brain biomarkers analysed by immunoenzymatic assay (ELISA). Secondary endpoints are memory function, intelligence, learning ability, self-reported cognitive function, and emotional symptomatology. Assessments take place after the enrolment (baseline; T<sub>1</sub>), after completing the interventions (5 months after baseline; T<sub>2</sub>), and after completing the follow-up period (8 months after baseline; T<sub>3</sub>).</p></div><div><h3>Discussion</h3><p>Given the importance of improving care for breast cancer survivors, this study will provide preliminary evidence for the effectiveness of cognitive-motor training (dual task) as a therapeutic strategy to improve CRCI. Moreover, addressing muscle-brain crosstalk by representative biomarkers will help to elucidate the underlying mechanisms by which this intervention may beneficially impact CRCI.</p><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT06073717</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107672"},"PeriodicalIF":2.0000,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of a motor and cognitive training program on executive function and different biomarkers related to muscle-brain crosstalk in breast cancer survivors: 3-arm randomised controlled BRAINonFIT study protocol\",\"authors\":\"Jesus Orellana-Jaén , Matilde Mora-Fernández , Luis Carrasco-Páez\",\"doi\":\"10.1016/j.cct.2024.107672\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Cancer-related cognitive impairment (CRCI) is a significant but often neglected issue for breast cancer survivors that reduces their quality of life. Physical exercise and cognitive training have emerged as promising strategies for CRCI; however, evidence regarding its effectiveness is still unknown. A recently developed motor-cognitive training (dual-tasks) is proposed to examine its efficacy on executive function, physical fitness, emotional symptomatology, and important muscle-brain crosstalk biomarkers.</p></div><div><h3>Methods</h3><p>The BRAINonFIT study is a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks). Breast cancer survivors (stage I-IIIA) with completed chemotherapy are recruited from QuirónSalud Hospital in Seville. Principal outcomes are executive functions, measured by the Trail Making Test, Stroop and Digit Span Backwards; physical fitness, assessed by muscle strength, cardiorespiratory fitness, and body composition; and several muscle-brain biomarkers analysed by immunoenzymatic assay (ELISA). Secondary endpoints are memory function, intelligence, learning ability, self-reported cognitive function, and emotional symptomatology. Assessments take place after the enrolment (baseline; T<sub>1</sub>), after completing the interventions (5 months after baseline; T<sub>2</sub>), and after completing the follow-up period (8 months after baseline; T<sub>3</sub>).</p></div><div><h3>Discussion</h3><p>Given the importance of improving care for breast cancer survivors, this study will provide preliminary evidence for the effectiveness of cognitive-motor training (dual task) as a therapeutic strategy to improve CRCI. Moreover, addressing muscle-brain crosstalk by representative biomarkers will help to elucidate the underlying mechanisms by which this intervention may beneficially impact CRCI.</p><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT06073717</span><svg><path></path></svg></span></p></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"146 \",\"pages\":\"Article 107672\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-09-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424002556\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002556","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Effects of a motor and cognitive training program on executive function and different biomarkers related to muscle-brain crosstalk in breast cancer survivors: 3-arm randomised controlled BRAINonFIT study protocol
Introduction
Cancer-related cognitive impairment (CRCI) is a significant but often neglected issue for breast cancer survivors that reduces their quality of life. Physical exercise and cognitive training have emerged as promising strategies for CRCI; however, evidence regarding its effectiveness is still unknown. A recently developed motor-cognitive training (dual-tasks) is proposed to examine its efficacy on executive function, physical fitness, emotional symptomatology, and important muscle-brain crosstalk biomarkers.
Methods
The BRAINonFIT study is a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks). Breast cancer survivors (stage I-IIIA) with completed chemotherapy are recruited from QuirónSalud Hospital in Seville. Principal outcomes are executive functions, measured by the Trail Making Test, Stroop and Digit Span Backwards; physical fitness, assessed by muscle strength, cardiorespiratory fitness, and body composition; and several muscle-brain biomarkers analysed by immunoenzymatic assay (ELISA). Secondary endpoints are memory function, intelligence, learning ability, self-reported cognitive function, and emotional symptomatology. Assessments take place after the enrolment (baseline; T1), after completing the interventions (5 months after baseline; T2), and after completing the follow-up period (8 months after baseline; T3).
Discussion
Given the importance of improving care for breast cancer survivors, this study will provide preliminary evidence for the effectiveness of cognitive-motor training (dual task) as a therapeutic strategy to improve CRCI. Moreover, addressing muscle-brain crosstalk by representative biomarkers will help to elucidate the underlying mechanisms by which this intervention may beneficially impact CRCI.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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