Exercise Training in Sarcoidosis (EXTRAS Study)
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ClinicalTrials.gov Identifier: NCT00099424 |
Recruitment Status
:
Completed
First Posted
: December 14, 2004
Last Update Posted
: June 5, 2008
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoidosis | Behavioral: High-intensity exercise training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single |
Official Title: | EXercise TRAining in Sarcoidosis (EXTRAS Study): A Prospective, Randomized, Controlled, Crossover Trial |
Study Start Date : | February 2004 |
Study Completion Date : | August 2005 |
- 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
- 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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099424
Belgium | |
University Hospital Leuven | |
Leuven, Vlaams-Brabant, Belgium, B-3000 |
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 |
ClinicalTrials.gov Identifier: | NCT00099424 History of Changes |
Other Study ID Numbers: |
ML2563 |
First Posted: | December 14, 2004 Key Record Dates |
Last Update Posted: | June 5, 2008 |
Last Verified: | June 2008 |
Keywords provided by University Hospital, Gasthuisberg:
exercise training resistance training endurance training Boeck's Sarcoid Besnier-Boeck Disease |
Additional relevant MeSH terms:
Sarcoidosis Lymphoproliferative Disorders Lymphatic Diseases |