- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00854672
Muscle Strength and Exercise Capacity in Sarcoidosis Patients
Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maastricht, Netherlands
- Maastricht University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines
Exclusion Criteria:
- not being able to walk
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise capacity, muscle strength and fatigue in sarcoidosis: a two-year follow-up study
Time Frame: 30 months
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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).
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30 months
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Collaborators and Investigators
Collaborators
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
Publications and helpful links
General Publications
- Marcellis RG, Lenssen AF, Elfferich MD, De Vries J, Kassim S, Foerster K, Drent M. Exercise capacity, muscle strength and fatigue in sarcoidosis. Eur Respir J. 2011 Sep;38(3):628-34. doi: 10.1183/09031936.00117710. Epub 2011 Mar 24.
- Marcellis RG, Lenssen AF, Kleynen S, De Vries J, Drent M. Exercise capacity, muscle strength, and fatigue in sarcoidosis: a follow-up study. Lung. 2013 Jun;191(3):247-56. doi: 10.1007/s00408-013-9456-6. Epub 2013 Apr 5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 09-4-007
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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