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

NCT06558591 | Not Yet Recruiting DMC

• 1 other identifier: SMandigout_ADEPINA
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Disease; Chronic Condition; Stroke Sequelae; Age Problem; Parkinson Disease

Keywords

Physical training; Telerehabilitation; Fitness test; health professional; chronic disease

Outcome Measures

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

  Day 0, Week 12, Week 18

Secondary Outcomes (5)

• To evaluate the impact of the intervention on patient's lower limb strengh

  Day 0, Week 12, Week 18

• To evaluate the impact of the intervention on patient's dynamic balance

  Day 0, Week 12, Week 18

• To assess the impact of the intervention onpatient's quality of life

  Day 0, Week 12, Week 18

• The adherence to the rehabilitation exercise program will be assessed by evaluating the system usage time by participants

  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).

  Week 12, Week 18.

Study Arms (1)

Chronic disease patients

EXPERIMENTAL

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

Device: Telerehabilitation intervention

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.

Chronic disease patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Be able to walk with or without assistives devices
• Be capable of giving informed consent,
• Be registered with the French health social security system,
• Be under the care of a rehabilitation exercise professional.
• Have an intolerance or inability to use digital tools,
• Have a cognitive impairment,
• Have contraindications to physical activity (unstable diabetes, unstable hypertension, unstable angina, intracardiac thrombus).

Sponsors & Collaborators

• Limoges University: lead
• Regional Health Agency New Aquitaine: collaborator
• University Hospital, Limoges: collaborator

Related Publications (7)

• Hwang R, Bruning J, Morris NR, Mandrusiak A, Russell T. Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial. J Physiother. 2017 Apr;63(2):101-107. doi: 10.1016/j.jphys.2017.02.017. Epub 2017 Mar 14.

  PMID: 28336297 BACKGROUND

• Batalik L, Dosbaba F, Hartman M, Konecny V, Batalikova K, Spinar J. Long-term exercise effects after cardiac telerehabilitation in patients with coronary artery disease: 1-year follow-up results of the randomized study. Eur J Phys Rehabil Med. 2021 Oct;57(5):807-814. doi: 10.23736/S1973-9087.21.06653-3. Epub 2021 Feb 23.

  PMID: 33619944 BACKGROUND

• Wu YQ, Long Y, Peng WJ, Gong C, Liu YQ, Peng XM, Zhong YB, Luo Y, Wang MY. The Efficacy and Safety of Telerehabilitation for Fibromyalgia: Systematic Review and Meta-analysis of Randomized Controlled Trials. J Med Internet Res. 2023 Apr 25;25:e42090. doi: 10.2196/42090.

  PMID: 37097721 BACKGROUND

• Scott Kruse C, Karem P, Shifflett K, Vegi L, Ravi K, Brooks M. Evaluating barriers to adopting telemedicine worldwide: A systematic review. J Telemed Telecare. 2018 Jan;24(1):4-12. doi: 10.1177/1357633X16674087. Epub 2016 Oct 16.

  PMID: 29320966 RESULT

• Mura A, Maier M, Ballester BR, De la Torre Costa J, Lopez-Luque J, Gelineau A, Mandigout S, Ghatan PH, Fiorillo R, Antenucci F, Coolen T, Chivite I, Callen A, Landais H, Gomez OI, Melero C, Brandi S, Domenech M, Daviet JC, Zucca R, Verschure PFMJ. Bringing rehabilitation home with an e-health platform to treat stroke patients: study protocol of a randomized clinical trial (RGS@home). Trials. 2022 Jun 20;23(1):518. doi: 10.1186/s13063-022-06444-0.

  PMID: 35725616 RESULT

• Seinsche J, de Bruin ED, Saibene E, Rizzo F, Carpinella I, Ferrarin M, Ifanger S, Moza S, Giannouli E. Feasibility and Effectiveness of a Personalized Home-Based Motor-Cognitive Training Program in Community-Dwelling Older Adults: Protocol for a Pragmatic Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 9;12:e49377. doi: 10.2196/49377.

  PMID: 37943591 RESULT

• Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4.

  PMID: 27592691 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Chronic Disease; Parkinson Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Stephane Mandigout, Full professor

CONTACT

+33 5 55 45 76 32; stephane.mandigout@unilim.fr

Justine Lacroix, Associate professor

CONTACT

+33 5 55 45 76 32; justine.lacroix@unilim.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective pilot study.

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: August 16, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share