NCT00854672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

7 months

First QC Date

February 26, 2009

Last Update Submit

April 5, 2012

Conditions

Keywords

Sarcoidosismuscle strengthexercise intoleranceQOL

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines

You may not qualify if:

  • not being able to walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Rik Marcellis, MSc

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR
  • Marjolein Drent, MD, PhD

    Maastricht University Medical Center and University Maastricht

    STUDY CHAIR
  • Ton Lenssen, MSc, PhD

    Maastricht UMC and University of Maastricht

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Marjolein Drent

Study Record Dates

First Submitted

February 26, 2009

First Posted

March 3, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

September 1, 2011

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations