Exercise Training in Sarcoidosis (EXTRAS Study)

June 4, 2008 updated by: University Hospital, Gasthuisberg

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, B-3000
        • University Hospital Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

Investigators

  • Principal Investigator: Martijn A. Spruit, PhD, KU Leuven
  • Study Director: Marc Decramer, PhD MD, University Hospital, Gasthuisberg
  • Study Chair: Michiel J. Thomeer, MD, University Hospital, Gasthuisberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

December 13, 2004

First Submitted That Met QC Criteria

December 13, 2004

First Posted (Estimate)

December 14, 2004

Study Record Updates

Last Update Posted (Estimate)

June 5, 2008

Last Update Submitted That Met QC Criteria

June 4, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML2563

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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