Feasibility and Potential Impact of an Individualized Exercise Program Via a Telerehabilitation Device in Chronic Patients: A Pilot Study

Sponsor
Limoges University
Study ID
NCT06558591
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telerehabilitation intervention — DEVICE
    Inclusion will take place within the framework of routine care for individuals with chronic diseases in rehabilitation services, hospitals, institutions, etc. The study will be offered to patients with chronic illnesses who are being cared for by their therapists. Data collection will be conducted in two sessions. The period between the two sessions will be determined based on the patient's availability, not exceeding a period of 12 weeks: 1. 1st session at 0 week : Conducting activities and initial evaluation at their usual care center. Therapists will perform the various planned tests and evaluations. 2. 2nd session at 12 weeks : This session will take place under the same conditions as the first one and without any potential health risks to the participants. 3. A final evaluation will be carried out at the 18-week follow-up. A telephone call will be made between sessions to check in and assist participants in case of any issues during the study.

Study Details

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.

Key Dates

First listed
Aug 16, 2024
Start date
Jan 31, 2025
Status verified
Aug 2024
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chronic disease patients
    The only intervention group (chronic disease patients) will use the ADEPINA device as part of their conventional treatment.

Primary Outcome Measure

To assess functional improvement, measured by the 6-minute walk test (6MWT) after the 12 weeks ER program in people with chronic disease. [ Time Frame: Day 0, Week 12, Week 18 ]

Central Contacts

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