NCT00099424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

First QC Date

December 13, 2004

Last Update Submit

June 4, 2008

Conditions

Sarcoidosis

Keywords

exercise trainingresistance trainingendurance trainingBoeck's SarcoidBesnier-Boeck Disease

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

High-intensity exercise trainingBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Main diagnosis: previously diagnosed sarcoidosis according to the latest ATS/ERS/WASOG statement on sarcoidosis (AJRCCM 1999)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, Vlaams-Brabant, B-3000, Belgium

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Martijn A. Spruit, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Marc Decramer, PhD MD

    University Hospital, Gasthuisberg

    STUDY DIRECTOR

  • Michiel J. Thomeer, MD

    University Hospital, Gasthuisberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2004

First Posted

December 14, 2004

Study Start

February 1, 2004

Study Completion

August 1, 2005

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations

BE(1)