SarcoidosisNCT00854672
Muscle Strength and Exercise Capacity in Sarcoidosis Patients
An observational study of Sarcoidosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines
Who cannot join
- not being able to walk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcoidosis
- Keywords
- Sarcoidosis, muscle strength, exercise intolerance, QOL
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ild care foundation
- Responsible party
- Principal investigator, marjolein drent, Maastricht University Medical Center
- Investigators
- Rik Marcellis, MSc, Principal investigator, Maastricht University Medical CenterMarjolein Drent, MD, PhD, Study chair, Maastricht University Medical Center and University MaastrichtTon Lenssen, MSc, PhD, Study director, Maastricht UMC and University of Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854672
- Sponsor's protocol ID
- MEC 09-4-007
- Status last verified
- Apr 2012
- First submitted
- 26 Feb 2009
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21436356Marcellis 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.
PubMed 23558599
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study
- ClinicalTrials.gov ID
- NCT00854672
- Acronym / sponsor ID
- MEC 09-4-007
- Conditions
- Sarcoidosis
- Keywords
- Sarcoidosis, muscle strength, exercise intolerance, QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ild care foundation
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines
Key exclusion criteria (1 listed)
- not being able to walk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Results publication: PubMed 21436356Marcellis 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.
- Derived from this study: PubMed 23558599Marcellis 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.
- official site of the Maastricht University Medical CentreLink provided by the sponsor.
Related trials for Sarcoidosis
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Cardiac Sarcoidosis Multi-Center Prospective Cohort
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
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Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rik Marcellis, MSc principal investigator
Maastricht University Medical Center
Marjolein Drent, MD, PhD study chair
Maastricht University Medical Center and University Maastricht
Ton Lenssen, MSc, PhD study director
Maastricht UMC and University of Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity, muscle strength and fatigue in sarcoidosis: a two-year follow-up study (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00854672, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.