JMIR Research Protocols最新文献

Background: Home-based cardiac rehabilitation is a promising approach to improve access and adherence to cardiac rehabilitation (CR), which remains underutilized. However, monitoring patient adherence and safety during home-based exercise is challenging. Therefore, we develop and implement a home-based exercise cardiac telerehabilitation (HBECTR) program, integrating structured exercise guidance with remote monitoring.

Objective: This trial is designed as a pilot feasibility study to evaluate the practicality, safety, and preliminary effects of HBECTR in patients who have undergone percutaneous coronary intervention (PCI). The primary objective is to analyze the effect of HBECTR on patients' adherence to CR, while the secondary objective is to measure the effect of HBECTR on the functional capacity of patients after PCI.

Methods: This study is a quasi-experimental nonequivalent control group pretest-posttest. The eligible participants are adults (≥18 y), patients with coronary artery disease after successful PCI, and patients having active health insurance. Patients will be consecutively recruited from Dr. Sardjito General Hospital, Yogyakarta, Indonesia, with a minimum of 60 patients after PCI as samples, divided into 2 groups: an intervention group and a comparison or control group. The intervention group will receive hybrid cardiac rehabilitation. Patients will be scheduled to do exercise twice a week at the hospital and 3 times a week at their home. When patients exercise at home, they will have to wear the smartwatch "CovWatch," which will be connected to the web-based app (App Rehab Cardio) to monitor their vital signs and the distance of walking. The control group will get usual care (center-based cardiac rehabilitation). The data will be analyzed using the Student t test to see if the data comply with the normality assumption. This protocol received approval from the institutional review board of the Faculty of Medicine, Public Health, and Nursing UGM (approval number: KE/FK/0850/EC/2024).

Results: The recruitment of the patients started in August 2024. This study is being funded since February 2025. During the submission, we have recruited 63 patients in both intervention and control groups. The intervention for both groups was finished in June 2025, and the data are being analyzed.

Conclusions: It is expected that the HBECTR program will be feasible and safely implemented in low- and middle-income countries, particularly in Indonesia. By integrating a telerehabilitation model, it is expected that HBECTR will improve patients' adherence to CR and also increase the functional capacity of patients after PCI.

Background: Chronic ocular surface pain (COSP), occurring either in isolation or as part of numerous ocular conditions, such as dry eye syndrome, is a leading cause of eye care visits in the United States. Conventional treatments directed at the ocular surface-the perceived pain source-are often inadequate for pain relief. We hypothesize that some individuals with COSP are experiencing symptoms driven by central nervous system (CNS) dysfunction, similar to chronic overlapping pain conditions, rather than solely pathological problems in the eye. Some individuals with chronic overlapping pain conditions (eg, fibromyalgia) show evidence of nociplastic pain mechanisms, where the pain results from amplified or dysregulated CNS signaling and sensory processing. Although data exist suggesting the presence of nociplastic pain features in COSP, there is a need for comprehensive studies.

Objective: Our aim is to rigorously define the role of nociplastic pain in COSP with a large, representative cohort of 200 participants with COSP using established clinical, neurobiological, and treatment response features. We propose that as sign and symptom discordance increases, features indicative of nociplastic pain will also increase.

Methods: In aim 1, we will clinically phenotype participants with COSP, using validated patient-reported outcome measures and standard ocular exams. In aim 2, we will compare the neurobiological features of nociplastic pain across the discordance spectrum among a subset of aim 1 participants using multimodal evoked sensory testing (pressure, thermal, and visual testing) at sites both local to and remote from the eye. Participants will also complete structural and functional brain magnetic resonance imaging to assess regions important for pain perception and modulation. In aim 3, we will examine and validate predictors of COSP pain responses before and after application of a topical anesthetic to the ocular surface, which should block peripherally induced discomfort to allow for clarification of pain origination.

Results: We received funding for this project in August 2024. Recruitment and enrollment began in January 2025 after protocol development and piloting were completed. This study is ongoing with 59 participants enrolled and 51 participants completing the study visits as of January 2026.

Conclusions: Findings from the study have the potential to fundamentally change the way ocular pain syndromes are conceptualized, diagnosed, and treated. This work will not only help identify new CNS-directed pain treatments for a subset of patients with COSP but also help us better understand why many peripherally directed therapies are destined to be ineffective in a subset of individuals experiencing COSP.

International registered report identifier (irrid): DERR1-10.2196/84240.

Background: Innovative approaches, such as virtual reality (VR)-based cognitive rehabilitation, are becoming essential to healthy aging.

Objective: This study aims to evaluate the feasibility and generate preliminary evidence regarding the effectiveness of an immersive VR-based cognitive remediation intervention for older individuals with mild cognitive impairment (MCI).

Methods: A total of 40 individuals aged 65 years and older, of both genders with MCI, will be recruited and randomly assigned to the experimental or control group. The experimental group will participate in a 6-week VR-based cognitive remediation program, while the control group will receive healthy lifestyle education. Feasibility will be assessed through measures, including dropout rates, side effects, and satisfaction with the program. Preliminary effectiveness will be evaluated using assessments of cognitive functions, quality of life, functional mobility, depression and anxiety symptoms, regulation of social and biological rhythms, body awareness, and physical activity levels.

Results: Recruitment began in May 2024 and is expected to conclude by November 2025; to date, 153 participants have been recruited and screened, with 39 enrolled. Preliminary analyses are planned for January 2026 and follow-up analyses for January 2027.

Conclusions: This trial will provide insights into the feasibility and preliminary effectiveness of a VR-based intervention for older adults with MCI, with implications for its integration into preventive and rehabilitative care.

Trial registration: ClinicalTrial.gov NCT06579378; https://clinicaltrials.gov/search?term=NCT06579378.

International registered report identifier (irrid): DERR1-10.2196/85089.

Background: Emerging adults (ie, those aged 18 to 25 years) in the United States exhibit the poorest diet quality among all adult age groups, contributing to adverse health and academic outcomes. Existing nutrition education programs often overlook this population, particularly those without children.

Objective: This study aims to present the development of a nutrition education curriculum for emerging adults, including its process and outcome evaluation strategies and measures.

Methods: The Fuel to Thrive program was adapted from an established state program for adults. The content was informed by reviewing the literature, conducting focus groups with health educators, and holding regular meetings with a curriculum committee. The final program consists of five 1-hour lessons incorporating nutrition education, recipe demonstrations, and physical activity. Process evaluation will involve focus groups with participants and interviews with educators to assess relevance and feasibility. Outcome evaluation will include surveys administered before and after the program to assess dietary behaviors, physical activity, food safety, and food resource management.

Results: The program is currently being piloted at a Texas university. Additional implementations are planned for fall 2025 and spring 2026, with the inclusion of the Short Healthy Eating Index Survey to better assess diet quality changes.

Conclusions: The Fuel to Thrive program addresses a critical gap in nutrition education for emerging adults by offering a tailored curriculum. Future iterations will refine the program based on participant and educator feedback and expand evaluation efforts. The long-term goal is national dissemination to improve dietary behaviors and health outcomes among emerging adults.

International registered report identifier (irrid): DERR1-10.2196/81647.

Background: Individuals who undergo metabolic and bariatric surgery (MBS) are at increased risk for postoperative alcohol use disorder. Reducing postoperative alcohol use could prevent the development of alcohol use disorder; however, the factors leading to episodic alcohol use are not known.

Objective: The purpose of this paper is to describe the protocol for a study that will examine distal and proximal factors associated with episodic alcohol use and hazardous alcohol use among individuals who undergo MBS.

Methods: We will enroll 100 participants who undergo MBS at a single health care system. Participants will complete measures of substance use, psychiatric symptoms, and disordered eating behaviors at baseline and at 6- and 12-week follow-ups. Participants will also complete a 3-week ecological momentary assessment protocol in which they will complete brief surveys each morning and evening, reporting on their mood, disordered eating, and substance use.

Results: This study received funding from the National Institute on Alcohol Abuse and Alcoholism (R21 AA029423) in May 2023. This part of the grant was approved by the institutional review board in March 2024, and data collection occurred between November 2024 and December 2025. We anticipate that our study protocol will be feasible and that we will observe at least 80% participant retention at the follow-up assessments and their response to at least 75% of ecological momentary assessment signals. We hypothesize that depressive symptoms (distal factor) and negative affect (proximal factor) will be associated with increased alcohol use, and alcohol use will occur in lieu of disordered eating behaviors.

Conclusions: Findings will help us understand distal and proximal factors leading to episodic alcohol use after undergoing MBS. This knowledge will allow us to construct better monitoring strategies for postoperative alcohol use within MBS programs and identify targets for intervention to reduce alcohol use after undergoing MBS.

International registered report identifier (irrid): DERR1-10.2196/87209.