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Muscle Strength and Exercise Capacity in Sarcoidosis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00854672
First Posted: March 3, 2009
Last Update Posted: April 6, 2012
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.
Collaborator:
ild care foundation
Information provided by (Responsible Party):
marjolein drent, Maastricht University Medical Center
February 26, 2009
March 3, 2009
April 6, 2012
January 2009
August 2009   (Final data collection date for primary outcome measure)
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).
6 MWD, and muscle strength measurements of hand, arm and leg muscles. Questionnaires: WHOQOL-bref, Small Fibre Neuropathy Scoring List(SFNSL) and Fatigue Assessment Score (FAS) [ Time Frame: 9 months ]
Complete list of historical versions of study NCT00854672 on ClinicalTrials.gov Archive Site
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Muscle Strength and Exercise Capacity in Sarcoidosis Patients
Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
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
Sarcoidosis
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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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
September 2011
August 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines

Exclusion Criteria:

  • not being able to walk
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00854672
MEC 09-4-007
Yes
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marjolein drent, Maastricht University Medical Center
Maastricht University Medical Center
ild care foundation
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
Maastricht University Medical Center
April 2012