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

March 9, 2020 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Department of clinical Physiology - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minutes walking distance
Time Frame: 10 years
6 minutes walking distance
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: 10 years
death
10 years
health-related quality of life
Time Frame: 10 years
health-related quality of life : VQ-11 questionnaire
10 years
Forced expiratory volume in 1 seconde
Time Frame: 10 years
Forced expiratory volume in 1 seconde : FEV1
10 years
BODE index
Time Frame: 10 years
BODE index
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Farés Gouzi, MD, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2018

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ACTUAL)

December 30, 2019

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (ACTUAL)

October 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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