Muscle Strength and Exercise Capacity in Sarcoidosis Patients

This study has been completed.
Sponsor:
Collaborator:
ild care foundation
Information provided by (Responsible Party):
marjolein drent, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00854672
First received: February 26, 2009
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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
Sarcoidosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Exercise capacity, muscle strength and fatigue in sarcoidosis: a two-year follow-up study [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 124
Study Start Date: January 2009
Study Completion Date: September 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: February 26, 2009
Last Updated: April 5, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014