Feasibility and Potential Impact of an Individualized Exercise Program Via a Telerehabilitation Device in Chronic Patients: A Pilot Study
NCT Number: NCT06558591
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Disease|Chronic Condition|Stroke Sequelae|Age Problem|Parkinson Disease
Interventions: DEVICE: Telerehabilitation intervention
Sponsor: Limoges University
Collaborators: Regional Health Agency New Aquitaine|University Hospital, Limoges
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2027-07

Summary:
Exercise Rehabilitation (ER) is widely used and effective in the treatment of chronic diseases; however, patients do not adhere to ER programs. Tele-rehabilitation is effective and often used to support and improve patient adherence. Thus, the ADEPINA device could be a promising solution for the individualized management of patients by their therapists. The aim of the study will be: a) To assess functional improvement, measured by the 6-minute walk test (6MWT) after the 12 weeks ER program in people with chronic disease. Additionally, the study will assess the individualized program' adherence and his effect on patients' physical fitness and quality of life. Methods: Fifty patients will follow individualized ER sessions to their patients (with chronic diseases) using the ADEPINA device, 2 to 3 times per week for 12 weeks. At the end of the intervention, the investigator will assess patients' lower limb strength (with sit to stand test), dynamic balance (Timed up and go test), patients' adherence to the ER program by evaluating the usage time of the system by participants, the treatment credibility and participant expectations for improvement will be assessed with the French version of the Credibility and Expectancy Questionnaire. The investigator will also evaluate the patients' quality of life (using the "World Health Organization Quality of Life" (WHOQOL) scale) at the beginning and end of the intervention. Discussion: This interventional pilot study could have positive impacts for participants and explore gaps in the current literature regarding the individualized telerehabilitation program' feasibility.

Primary Outcome Measures: To assess functional improvement, measured by the 6-minute walk test (6MWT) after the 12 weeks ER program in people with chronic disease., The investigator will assess the 6-minutes walk distance change after the intervention, Day 0, Week 12, Week 18
Secondary Outcome Measures: To evaluate the impact of the intervention on patient's lower limb strengh, Physical fitness will be assessed using a clinical test (a 30 seconde' sit to stand test) validated and standardized among the chronic disease population., Day 0, Week 12, Week 18|To evaluate the impact of the intervention on patient's dynamic balance, Physical fitness will be assessed using a clinical test (a time up and go test) validated and standardized among the chronic disease population., Day 0, Week 12, Week 18|To assess the impact of the intervention onpatient's quality of life, Quality of life will be assessed using the World Health Organization Quality of Life (WHOQOL) questionnaire, Day 0, Week 12, Week 18|The adherence to the rehabilitation exercise program will be assessed by evaluating the system usage time by participants, Specifically, this study will examine program adherence through the rate of patients who completed the intervention sessions and evaluations, Week 12, Week 18.|The treatment credibility and participant expectations for improvement were assessed with the French version of the Credibility and Expectancy Questionnaire (CEQ)., The CEQ includes a Credibility subscale (3 items) and an Expectancy subscale (3 items). The Credibility subscale has a 1-9 rating scale (1 "not at all" to 9 "very") for a total sub-score ranging from 3 to 27. The Expectancy scale has a 0-100% scale, and item 2 has a 1-9 rating scale for a total sub-score ranging from 3 to 27 after transforming the percentage scales. A moderate score ranges between 13.50 and 20.25; scores above 20.25 are considered high., Week 12, Week 18.