Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— m-Rehab COPD  

Official title:

Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550741
• Other study ID #: UF 9797
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: Maurice HAYOT, MD, PhD
• Phone: +33 467 335 908
• Email: m-hayot[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.

In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.

In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

Description:

Exclusion criteria:

• Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).

• Patients with significant and unstable cardiovascular disease.

• Inability to understand and/or answer questionnaires.

• Refusal to use a smartphone or digital device.

• Unable to access an internet connection at home.

Analysis:

• The main analysis will be the univariate intention-to-treat analysis of the primary outcome.

• Secondary analyzes will include:

• Analysis with intention to treat secondary endpoints.

• Multivariate analysis of the efficiency criteria.

• Univariate and multivariate medico - economic cost - utility analyzes, with their respective sensitivity analyzes.

Protocol:

This prospective, randomized study with two parallel arms, controlled against standard chronic care will be multicentric and open.

• Patients included will be patients diagnosed with COPD who are on RR for four weeks in one of the three centers participating in the study.

• Participation in the study will be offered after verification of the eligibility criteria, during the 3rd week of the stay.

• The information note will then be provided to them.

• After obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms:

• - Experimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution. The solution will be provided during the fourth and final week of RR's stay during which patients will be trained to use all of the solution's features. Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1, 3, 6 and 12 months as well as assessments at 3, 6 and 12 months by filling. electronic auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home.

• Control group of 100 patients following usual standard chronic care. Patients will receive during the last week of stay in the center, the usual advice to continue physical activity and nutritional advice at home. The evaluations at 3, 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home.

The duration of the inclusions is 18 months and the follow-up will be carried out over 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 78 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with COPD according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) creteria.

• Presence of an incompletely reversible obstructive ventilatory disorder defined by a report VEMS / CVF lower than the lower limit of normal post-bronchodilator.

• Patient on RR for four weeks in respiratory rehabilitation center.

• Aged between 40 and 78 years.

Exclusion Criteria:

• Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).

• Patients with significant and unstable cardiovascular disease.

• Inability to understand and/or answer questionnaires.

• Refusal to use a smartphone or digital device.

• Unable to access an internet connection at home.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• telerehabilitation
After obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms: Experimental and Control group

Locations

Country	Name	City	State
France	Centre hopsitalier universitaire de Montpellier	Montpellier	Occitanie
France	Clinique du Souffle	Osséja

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program	Quality of life assessed by the Saint Georges Respiratory Questionnaire. Three scores are calculated for the components: Symptoms; Activities; Impacts. A Total SCORE is also calculated.; The minimum significant difference is 4 points.	12 months
Secondary	Pre-intentional variables	Perceived risk: questionnaire focused on respiratory disease and conditioned by absence of adoption of physical activity behavior.; Expectation of conséquences: questionnaire of the expected effects of Physical activity on physical health and psychological well-being.; Self-efficacy: questionnaire relating to their perceived ability to perform the quantity of physical activity recommended by healthcare professionals.; Intentions: determination and realization of physical activity behavior in the next months.	baseline
Secondary	Post-intentional variables	planning: by a Questionnaire relating to the anticipation of the conditions to realize physical activity.; self-efficacy with regard to barriers: questionnaire relating to their perceived ability to perform physical activity recommended despite the difficulties encountered.; Social support:questionnaire relating to the behavior of the entourage habits: questionnaire on automatic nature of physical activity behavior.	6 months
Secondary	Physical Activity behaviors.	Measured by the International Physical Activity Questionnaire as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.; walking consider to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.	12 months
Secondary	Predictive model of physical activity behavior	Test a predictive model of physical activity behavior at 12 months in each of the two arm groups.	At 12 months