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OpenTrials
Completed

NCT Number: NCT03704935

Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program

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.

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Key information

Conditions

Chronic Respiratory Disease

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of clinical Physiology - University Hospital

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 6 minutes walking distance

    Time frame: 10 years

    6 minutes walking distance

Secondary outcomes

  1. health-related quality of life

    Time frame: 10 years

    health-related quality of life : VQ-11 questionnaire

  2. Forced expiratory volume in 1 seconde

    Time frame: 10 years

    Forced expiratory volume in 1 seconde : FEV1

  3. BODE index

    Time frame: 10 years

    BODE index

  4. death

    Time frame: 10 years

    death

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: LTAir+R

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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