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Exercise Training in Sarcoidosis (EXTRAS Study)

NCT ID: NCT00099424

Last Updated: 2008-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-08-31

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.

Conditions

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Sarcoidosis

Keywords

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exercise training resistance training endurance training Boeck's Sarcoid Besnier-Boeck Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Interventions

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High-intensity exercise training

Intervention Type BEHAVIORAL

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Principal Investigators

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Martijn A. Spruit, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Marc Decramer, PhD MD

Role: STUDY_DIRECTOR

University Hospital, Gasthuisberg

Michiel J. Thomeer, MD

Role: STUDY_CHAIR

University Hospital, Gasthuisberg

Locations

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University Hospital Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML2563

Identifier Type: -

Identifier Source: org_study_id