LTAir+R: Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03704935

Collaborator

(none)

1,000

Enrollment

Location

14.7

Actual Duration (Months)

68.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic respiratory diseases are characterized by a progressive and long term deline. Pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. After an inpatient PR program, maintenance program can stabilize the disease outcomes. However, maintenance program are heterogeneous and long term benefits (>36 month) have been observed in only one study, which is not feasible in France. A realistic maintenance program as proposed by the French Air+R network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. In addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. In particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a "spill-over" of inflammatory pulmonary molecules in the systemic milieu.

Condition or Disease	Intervention/Treatment	Phase
Chronic Respiratory Disease

Study Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program in Patients With a Chronic Respiratory Disease: Time Course and Determinants

Actual Study Start Date :

Oct 10, 2018

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Dec 30, 2019

Outcome Measures

Primary Outcome Measures

6 minutes walking distance [10 years]
6 minutes walking distance

Secondary Outcome Measures

health-related quality of life [10 years]
health-related quality of life : VQ-11 questionnaire
Forced expiratory volume in 1 seconde [10 years]
Forced expiratory volume in 1 seconde : FEV1
BODE index [10 years]
BODE index
death [10 years]
death

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Patients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, …) undergoing pulmonary rehabilitation (maintenance or inpatient)