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Pulmonary Rehabilitation in Patients With Sarcoidosis

U

University Hospital, Lille

Status

Terminated

Conditions

Stage 4 Pulmonary Sarcoidosis

Treatments

Other: Pulmonary rehabilitation program

Study type

Interventional

Funder types

Other

Identifiers

NCT02044939
2012-A00347-36 (Other Identifier)
2011_23/1917

Details and patient eligibility

About

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

Full description

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

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

Pulmonary rehabilitation
Experimental group
Description:
Sarcoidosis patients will realize a pulmonary rehabilitation program
Treatment:
Other: Pulmonary rehabilitation program
Controls
No Intervention group
Description:
Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling.

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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