Exercise Training in Sarcoidosis (EXTRAS Study)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
|Official Title:||EXercise TRAining in Sarcoidosis (EXTRAS Study): A Prospective, Randomized, Controlled, Crossover Trial|
- 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
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||August 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099424
|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|