Exercise Training in Sarcoidosis (EXTRAS Study)

Sponsor

University Hospital, Gasthuisberg (Other)

Overall Status

Completed

CT.gov ID

NCT00099424

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoidosis	Behavioral: High-intensity exercise training	N/A

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2004

Study Completion Date :

Aug 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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