Exercise Training in Sarcoidosis (EXTRAS Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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EXercise TRAining in Sarcoidosis (EXTRAS Study): A Prospective, Randomized, Controlled, Crossover Trial

Conditions
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Sarcoidosis

Intervention / Treatment
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* Behavioral: High-intensity exercise training


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: High-intensity exercise training|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise training, resistance training, endurance training, Boeck's Sarcoid, Besnier-Boeck Disease