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Completed

NCT Number: NCT02044939

Pulmonary Rehabilitation in Patients With Sarcoidosis

The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program.

The secondary objectives are the following:

* assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program * assess the improvement of exercise capacity by tests used in medical practice * assess the correlation between daily activity and exercise capacity * assess the improvement of dyspnea * assess the improvement of quality of life and psychological state

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Key information

Conditions

Stage 4 Pulmonary Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Respiratory Tract Diseases Sarcoidosis Sarcoidosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique des Maladies Respiratoires, CHRU de LILLE, Lille, Nord, France

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About this study

The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program

The secondary objectives are the following :

  • assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
  • assess the improvement of exercise capacity by tests used in medical practice
  • assess the correlation between daily activity and exercise capacity
  • assess the improvement of dyspnea
  • assess the improvement of quality of life and psychological state

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stage IV Sarcoidosis
  • No hospitalization for respiratory distress in the 3 months preceding the inclusion
  • Dyspnea on exertion
  • Age over 18 years

Exclusion criteria

  • Physical disability does not allow the creation of a rehabilitation program
  • Inability to give written consent to the study
  • Refusal of contraception in women of childbearing age
  • Inability to participate in the entire study
  • No cover by the social security system
  • Inability to perform self-questionnaires etude

The trial does not include special populations include:

  • Pregnant women
  • Breastfeeding women
  • People in emergencies
  • Persons unable to consent
  • Persons deprived of liberty

Treatment and study plan

Pulmonary rehabilitation program

Other

Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)

Primary outcomes

  1. Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET)

    Time frame: 12 months

    In everyday life, it corresponds to a walking in 5 km/h or in domestic chores. This measure will be realized by using Armband's accelerometer, in ambulatory. The measure will be realized over a period of 4 full days including the weekend.

Secondary outcomes

  1. Daily activity assessed by time spent in moderate activity (superior to 2,5 MET)

    Time frame: 2 and 6 months

  2. exercise capacity assessed by symptom-limited cardiopulmonary exercise test, 6 minutes walk test, endurance test on bicycle, St Etienne questionnaire, 6 minutes stepper test

    Time frame: 2, 6 and 12 months

  3. MRC scale for dyspnea

    Time frame: 2, 6 and 12 months

  4. Questionnaire to evaluate quality of life and/or psychological state : VSRQ

    Time frame: 2, 6 and 12 months

  5. Questionnaire to evaluate quality of life and/or psychological state : MRF 28

    Time frame: 2, 6 and 12 months

  6. Questionnaire to evaluate quality of life and/or psychological state : HAD

    Time frame: 2, 6 and 12 months

  7. Questionnaire to evaluate quality of life and/or psychological state : FAS

    Time frame: 2, 6 and 12 months

  8. Questionnaire to evaluate quality of life and/or psychological state : DIRECT

    Time frame: 2, 6 and 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2014
Registry last updated
Apr 7, 2026

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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