Skip to main content
OpenTrials
Completed

NCT Number: NCT00099424

Exercise Training in Sarcoidosis (EXTRAS Study)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Leuven

Leuven, Vlaams-Brabant, B-3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity exercise training

Behavioral

Primary outcomes

  1. Health status: Medical Outcomes Study 36-Item Short-Form Health Survey

  2. Disease-specific quality of life: Sarcoidosis Health Questionnaire

  3. Peak exercise capacity: a symptom-limited peak exercise test on a cycle ergometer

  4. Functional exercise capacity (I): a symptom-limited endurance cycling test at 70% of the achieved peak external load

  5. Functional exercise capacity (II): the distance walked in 6 minutes

Secondary outcomes

  1. Pulmonary function: forced vital capacity and transfer factor for carbon monoxide

  2. Muscle function: isometric quadriceps femoris muscle peak torque

  3. Systemic inflammation: circulating levels of IL-2, sIL-2r, IL-6, IL-8, TNF-alpha, sTNFR-p55, sTNFR-p75

  4. Anxiety and depression: Hospital Anxiety and Depression Scale

  5. Health-related quality of life (I): Chronic Respiratory Disease Questionnaire

  6. Health-related quality of life (II): St. George's Respiratory Questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Dec 14, 2004
Registry last updated
Jun 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.