Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program

Chronic Respiratory Disease Clinical Trial

— LTAir+R  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704935
• Other study ID #: RECHMPL18_0317
• Status: Completed
• Start date: October 10, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion criteria:

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

Exclusion criteria:

Contraindication to exercise training

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• Respiration Disorders
• Respiratory Tract Diseases

Locations

Country	Name	City	State
France	Department of clinical Physiology - University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minutes walking distance	6 minutes walking distance	10 years
Secondary	health-related quality of life	health-related quality of life : VQ-11 questionnaire	10 years
Secondary	Forced expiratory volume in 1 seconde	Forced expiratory volume in 1 seconde : FEV1	10 years
Secondary	BODE index	BODE index	10 years
Secondary	death	death	10 years