- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820988
MaSS - Maastricht Sarcopenia Study (MaSS)
January 18, 2016 updated by: Maastricht University Medical Center
Cross-sectional Study on the Identification and Characterization of Community-dwelling Older People With Sarcopenia
The objective of this cross-sectional study is to obtain insight in the characteristics (nutritional status and level of physical activity) of sarcopenic compared to non-sarcopenic community-dwelling older people.
There is one measurement moment and measurements will take place at the participant's home.
Study Overview
Status
Completed
Conditions
Detailed Description
- Characterization of sarcopenic older people (demographics, nutritional status, level of physical activity)
- Prevalence rates of sarcopenia in community-dwelling older people in the Netherlands
- Insight in differences and/or overlap between sarcopenia versus frailty
- Insight in the impact of sarcopenia on economic outcomes
Study Type
Observational
Enrollment (Actual)
247
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maastricht, Netherlands
- Maastricht University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 99 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Community-dwelling older people
Description
Inclusion Criteria:
- ≥ 65 years old
- Have given informed consent
- Understand Dutch language
- Able to perform a walk test
Exclusion Criteria:
- Older people living in a nursing home
- Older people with active rheumatoid arthritis, post stroke status with evident lingering symptoms (paralysis, loss of motor functions), diseases of the nervous system like Parkinson and MS, active angina pectoris, dementia
- Older people in a wheelchair, with ICD or pacemaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Sarcopenic vs. non-sarcopenic
Participants are classified as sarcopenic/non-sarcopenic according to the criteria of the European Working Group of Sarcopenia in Older People (EWGSOP).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Mean difference in nutritional status and level of physical activity of sarcopenic participants vs. non-sarcopenic participants, as a measure of a Food Frequency Questionnaire and Mini-Nutritional Assessment Tool and Minnesota questionnaire
Time Frame: 1 home visit
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1 home visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Prevalence of sarcopenia in community-dwelling older people
Time Frame: 1 home visit
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1 home visit
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Number of sarcopenic participants with frailty as a measure of the FRAIL scale and Fried criteria
Time Frame: 1 home visit
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1 home visit
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Health care costs by sarcopenic vs. non-sarcopenic participants, measured by health care use
Time Frame: 1 home visit
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1 home visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: J.M.G.A. Schols, Prof. Dr., Maastricht University
- Principal Investigator: R.J.G. Halfens, PhD, Maastricht University
- Principal Investigator: J.M.M. Meijers, PhD, Maastricht University
- Principal Investigator: D.M. Mijnarends, MSc, Maastricht University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mijnarends DM, Meijers JM, Halfens RJ, ter Borg S, Luiking YC, Verlaan S, Schoberer D, Cruz Jentoft AJ, van Loon LJ, Schols JM. Validity and reliability of tools to measure muscle mass, strength, and physical performance in community-dwelling older people: a systematic review. J Am Med Dir Assoc. 2013 Mar;14(3):170-8. doi: 10.1016/j.jamda.2012.10.009. Epub 2012 Dec 29.
- Mijnarends DM, Schols JM, Meijers JM, Tan FE, Verlaan S, Luiking YC, Morley JE, Halfens RJ. Instruments to assess sarcopenia and physical frailty in older people living in a community (care) setting: similarities and discrepancies. J Am Med Dir Assoc. 2015 Apr;16(4):301-8. doi: 10.1016/j.jamda.2014.11.011. Epub 2014 Dec 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
March 12, 2013
First Submitted That Met QC Criteria
March 26, 2013
First Posted (Estimate)
March 29, 2013
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 18, 2016
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 13-3-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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