Clinical trial NCT00099424: Exercise Training in Sarcoidosis (EXTRAS Study)
Official title: EXercise TRAining in Sarcoidosis (EXTRAS Study): A Prospective, Randomized, Controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Keywords: exercise training
resistance training
endurance training
Boeck's Sarcoid
Besnier-Boeck Disease
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2004-12-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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: 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 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

Primary outcomes:
measure: Health status: Medical Outcomes Study 36-Item Short-Form Health Survey
measure: Disease-specific quality of life: Sarcoidosis Health Questionnaire
measure: Peak exercise capacity: a symptom-limited peak exercise test on a cycle ergometer
measure: Functional exercise capacity (I): a symptom-limited endurance cycling test at 70% of the achieved peak external load
measure: Functional exercise capacity (II): the distance walked in 6 minutes
Secondary outcomes:
measure: Pulmonary function: forced vital capacity and transfer factor for carbon monoxide
measure: Muscle function: isometric quadriceps femoris muscle peak torque
measure: Systemic inflammation: circulating levels of IL-2, sIL-2r, IL-6, IL-8, TNF-alpha, sTNFR-p55, sTNFR-p75
measure: Anxiety and depression: Hospital Anxiety and Depression Scale
measure: Health-related quality of life (I): Chronic Respiratory Disease Questionnaire
measure: Health-related quality of life (II): St. George's Respiratory Questionnaire
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Martijn A. Spruit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Gasthuisberg
name: Marc Decramer, PhD MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Gasthuisberg
name: Michiel J. Thomeer, MD
role: STUDY_CHAIR
References: