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Muscle Strength and Exercise Capacity in Sarcoidosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00854672
Recruitment Status : Completed
First Posted : March 3, 2009
Last Update Posted : April 6, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to examine exercise capacity, muscle strength and fatigue in sarcoidosis. In this longitudinal study the changes in prevalence of exercise intolerance, reduced muscle strength and fatigue will be established in a two-year follow-up. Also the relation between these physical impairments in time and other clinical parameters, such as QOL, will be established.

Condition or disease
Sarcoidosis

Detailed Description:

The aim of this study is to examine exercise capacity, muscle strength and fatigue in sarcoidosis. In this longitudinal study the changes in prevalence of exercise intolerance, reduced muscle strength and fatigue will be established in a two-year follow-up. Also the relation between these physical impairments in time and other clinical parameters, such as QOL, will be established.

Study design: sarcoidosis patients referred to the ild care team of outpatient clinic of the department of Respiratory Medicine of the MUMC and also participated in the baseline study between November 2008 and September 2009 will be included in this longitudinal study. A six-minute walk test and peripheral muscle strength measurements (included in the regular clinical work-up of sarcoidosis patients) will be performed under supervision of a physical therapist at the department of physical therapy of the MUMC. Moreover, the patients will be asked to complete the WHOQOL-bref questionnaire and the Fatigue Assessment Scale. A maximum of 124 patients will be included.


Study Design

Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study
Study Start Date : January 2009
Primary Completion Date : August 2009
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
sarcoidosis patients
Sarcoidosis patients referred to the ild care team of the outpatient clinic of the department of Respiratory Medicine of the MUMC and also participated in the baseline study between November 2008 and September 2009 will be included in this study


Outcome Measures

Primary Outcome Measures :
  1. Exercise capacity, muscle strength and fatigue in sarcoidosis: a two-year follow-up study [ Time Frame: 30 months ]
    6MWD and muscle strength measurements of arm (isometric strength of the elbow flexors) and leg (isokinetic peak torques of the hamstrings and quadriceps) muscles. Questionnaires: WHOQOL-bref and Fatigue Assessment Scale (FAS).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Sarcoidosis patients referred to the ild care team of the outpatient clinic of the department of Respiratory Medicine of the Maastricht University Medical Centre (MUMC) a tertiary referral center in the Netherlands will be included in this study
Criteria

Inclusion Criteria:

  • diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines

Exclusion Criteria:

  • not being able to walk
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854672


Locations
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ild care foundation
Investigators
Principal Investigator: Rik Marcellis, MSc Maastricht University Medical Center
Study Chair: Marjolein Drent, MD, PhD Maastricht University Medical Center and University Maastricht
Study Director: Ton Lenssen, MSc, PhD Maastricht UMC and University of Maastricht
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: marjolein drent, Prof. Marjolein Drent, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00854672     History of Changes
Other Study ID Numbers: MEC 09-4-007
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by marjolein drent, Maastricht University Medical Center:
Sarcoidosis
muscle strength
exercise intolerance
QOL

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases