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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLimoges University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be a physiotherapist or kinesiologist working in the public sector, private sector, or in a mixed capacity,

Have been graduated for at least one year,

Conduct ER program with chronic patients and provide written consent.

Be 18 years of age or older,

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Chronic disease patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0, Week 12, Week 18

Secondary outcomes

1

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.

Time frame
Day 0, Week 12, Week 18
2

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.

Time frame
Day 0, Week 12, Week 18
3

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

Time frame
Day 0, Week 12, Week 18
4

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

Time frame
Week 12, Week 18.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Limoges University

Lead sponsor

Regional Health Agency New Aquitaine

Collaborator

University Hospital, Limoges

Collaborator

This trial is not recruiting at the moment. You can still explore other options: