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Exercise Training in Sarcoidosis (EXTRAS Study)
This study has been completed.
Sponsored by: University Hospital, Gasthuisberg
Information provided by: University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00099424
  Purpose

Exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness. The present researchers reason that skeletal muscle weakness is, at least in part, related to physical inactivity and therefore partially reversible following a structured exercise training program. Nevertheless, the effects of exercise training have never been studied in patients with sarcoidosis. Therefore, the present study is undertaken to explore the effects of exercise training in patients with sarcoidosis. A priori, the following hypotheses are formulated:

  • A 12-week exercise training program improves health status, quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
  • A 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
  • A 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.

Condition Intervention
Sarcoidosis
Behavioral: High-intensity exercise training

MedlinePlus related topics: Anxiety Depression Exercise and Physical Fitness Sarcoidosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title: EXercise TRAining in Sarcoidosis (EXTRAS Study): A Prospective, Randomized, Controlled, Crossover Trial

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Health status: Medical Outcomes Study 36-Item Short-Form Health Survey
  • Disease-specific quality of life: Sarcoidosis Health Questionnaire
  • Peak exercise capacity: a symptom-limited peak exercise test on a cycle ergometer
  • Functional exercise capacity (I): a symptom-limited endurance cycling test at 70% of the achieved peak external load
  • Functional exercise capacity (II): the distance walked in 6 minutes

Secondary Outcome Measures:
  • Pulmonary function: forced vital capacity and transfer factor for carbon monoxide
  • Muscle function: isometric quadriceps femoris muscle peak torque
  • Systemic inflammation: circulating levels of IL-2, sIL-2r, IL-6, IL-8, TNF-alpha, sTNFR-p55, sTNFR-p75
  • Anxiety and depression: Hospital Anxiety and Depression Scale
  • Health-related quality of life (I): Chronic Respiratory Disease Questionnaire
  • Health-related quality of life (II): St. George's Respiratory Questionnaire

Estimated Enrollment: 30
Study Start Date: February 2004
Estimated Study Completion Date: August 2005
Detailed Description:

The EXTRAS study is a prospective, randomized, controlled, 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa. Consenting participants will be assessed at baseline (before randomization, week 0) and at weeks 12 and 24.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Main diagnosis: previously diagnosed sarcoidosis according to the latest ATS/ERS/WASOG statement on sarcoidosis (AJRCCM 1999)

Exclusion Criteria:

  • A history of neurosarcoidosis
  • Undergoing structured exercise training at the time of enrollment or in the preceding 6 months
  • Current participation in a pharmacological study
  • Cardiovascular abnormalities on the ECG during baseline peak exercise test
  • A 'normal' baseline peak oxygen uptake (≥90% of the predicted values) in combination with a 'normal' quadriceps peak torque or distance walked in 6 minutes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099424

Locations
Belgium, Vlaams-Brabant
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium, B-3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Martijn A. Spruit, PhD Katholieke Universiteit Leuven
Study Director: Marc Decramer, PhD MD University Hospital, Gasthuisberg
Study Chair: Michiel J. Thomeer, MD University Hospital, Gasthuisberg
  More Information

Study ID Numbers: ML2563
Study First Received: December 13, 2004
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00099424  
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by University Hospital, Gasthuisberg:
exercise training
resistance training
endurance training
Boeck's Sarcoid
Besnier-Boeck Disease

Study placed in the following topic categories:
Lymphatic Diseases
Sarcoidosis
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on January 16, 2009