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

NCT04550741 | Completed

• 2 other identifiers: RECHMPL17_00302017-A01248-45
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Telerehabilitation; Telemedicine; Exercise training; Quality of life; E-health; Connected objects; Care manager

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pre-intentional variables

  baseline

• Post-intentional variables

  6 months

• Physical Activity behaviors.

  12 months

• Predictive model of physical activity behavior

  At 12 months

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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.

Other: telerehabilitation

Standard chronic care

NO INTERVENTION

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.

Interventions

telerehabilitation OTHER

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

Also known as: Digital solution of telerehabilitation with remote connected objects

Telerehabilitation

Eligibility Criteria

• Age: 40 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Centre hopsitalier universitaire de Montpellier

Montpellier, Occitanie, 34295, France

Location

Clinique du Souffle

Osséja, 66340, France

Location

Related Publications (1)

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  PMID: 33511633 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study will be an Open study. For the primary outcome the analysis will be blind to the investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: September 16, 2020
• Study Start: March 10, 2022
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: September 30, 2025

Record last verified: 2024-12

Locations

FR (2)