Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ild care foundation
Information provided by (Responsible Party):
marjolein drent, Maastricht University Medical Center

Tracking Information
First Submitted Date February 26, 2009
First Posted Date March 3, 2009
Last Update Posted Date April 6, 2012
Study Start Date January 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2012)
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).
Original Primary Outcome Measures
 (submitted: March 2, 2009)
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 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Muscle Strength and Exercise Capacity in Sarcoidosis Patients
Official Title Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study
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.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Sarcoidosis
Intervention Not Provided
Study Groups/Cohorts 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 5, 2012)
124
Original Estimated Enrollment
 (submitted: March 2, 2009)
100
Actual Study Completion Date September 2011
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines

Exclusion Criteria:

  • not being able to walk
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00854672
Other Study ID Numbers MEC 09-4-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party marjolein drent, Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators 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
PRS Account Maastricht University Medical Center
Verification Date April 2012