NCT03704935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

October 10, 2018

Last Update Submit

March 9, 2020

Conditions

Chronic Respiratory Disease

Keywords

Pulmonary rehabilitationMaintenance programCohortMicroenvironmentLong-term benefits

Outcome Measures

Primary Outcomes (1)

  • 6 minutes walking distance

    6 minutes walking distance

    10 years

Secondary Outcomes (4)

  • health-related quality of life

    10 years

  • Forced expiratory volume in 1 seconde

    10 years

  • BODE index

    10 years

  • death

    10 years

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Contraindication to exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of clinical Physiology - University Hospital

Montpellier, 34295, France

Location

Study Officials

  • Farés Gouzi, MD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

October 10, 2018

Primary Completion

April 30, 2019

Study Completion

December 30, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

FR(1)