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NCT00854672 Clinical Trial

Muscle Strength and Exercise Capacity in Sarcoidosis Patients

Sarcoidosis Clinical Trial

Official title:
Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00854672
Other study ID # MEC 09-4-007
Secondary ID
Status Completed
Phase N/A
First received February 26, 2009
Last updated April 5, 2012
Start date January 2009
Est. completion date September 2011

Study information
Verified date April 2012
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date September 2011
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines

Exclusion Criteria:

- not being able to walk

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Maastricht University Medical Center Maastricht

Sponsors (2)
Lead Sponsor Collaborator
Maastricht University Medical Center ild care foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Exercise capacity, muscle strength and fatigue in sarcoidosis: a two-year follow-up study 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). 30 months No
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