Clinical trial NCT00854672: Muscle Strength and Exercise Capacity in Sarcoidosis Patients
Official title: Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Keywords: Sarcoidosis
muscle strength
exercise intolerance
QOL
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ild care foundation
First posted: 2009-03-03
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines

Exclusion Criteria:

* not being able to walk

Primary outcomes:
measure: Exercise capacity, muscle strength and fatigue in sarcoidosis: a two-year follow-up study
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Rik Marcellis, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center and University Maastricht
name: Marjolein Drent, MD, PhD
role: STUDY_CHAIR
affiliation: Maastricht UMC and University of Maastricht
name: Ton Lenssen, MSc, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.