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 (m-Rehab COPD)

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    200
  • sponsor
    University Hospital, Montpellier
Updated on 30 June 2022

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.

Details
Condition Chronic Obstructive Pulmonary Disease
Treatment Telerehabilitation
Clinical Study IdentifierNCT04550741
SponsorUniversity Hospital, Montpellier
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note