SarcopeniaMaSSNCT01820988
MaSS - Maastricht Sarcopenia Study
An observational study of Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 247 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Dec 2015
- 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 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling older people
Who may be able to join
- ≥ 65 years old
- Have given informed consent
- Understand Dutch language
- Able to perform a walk test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
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 |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 home visit
Secondary outcomes (3)
Prevalence of sarcopenia in community-dwelling older people
Measured: 1 home visit
Number of sarcopenic participants with frailty as a measure of the FRAIL scale and Fried criteria
Measured: 1 home visit
Health care costs by sarcopenic vs. non-sarcopenic participants, measured by health care use
Measured: 1 home visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionDec 2015
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 SarcopeniaStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Research Fundation
- Responsible party
- Sponsor
- Investigators
- J.M.G.A. Schols, Prof. Dr., Study director, Maastricht UniversityR.J.G. Halfens, PhD, Principal investigator, Maastricht UniversityJ.M.M. Meijers, PhD, Principal investigator, Maastricht UniversityD.M. Mijnarends, MSc, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820988
- Sponsor's protocol ID
- METC 13-3-006
- Acronym
- MaSS
- Status last verified
- Apr 2015
- First submitted
- 12 Mar 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23276432Mijnarends 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.
PubMed 25530211
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study on the Identification and Characterization of Community-dwelling Older People With Sarcopenia
- ClinicalTrials.gov ID
- NCT01820988
- Acronym / sponsor ID
- MaSS / METC 13-3-006
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Nutricia Research Fundation
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Mar 2013 (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 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.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older people
Key inclusion criteria (4 listed)
- ≥ 65 years old
- Have given informed consent
- Understand Dutch language
- Able to perform a walk test
Key exclusion criteria (3 listed)
- 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
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
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
3 secondary outcomes
Prevalence of sarcopenia in community-dwelling older people
Time frame: 1 home visit
Number of sarcopenic participants with frailty as a measure of the FRAIL scale and Fried criteria
Time frame: 1 home visit
Health care costs by sarcopenic vs. non-sarcopenic participants, measured by health care use
Time frame: 1 home visit
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 20 Jan 2016.
- Results publication: PubMed 23276432Mijnarends 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.
- Results publication: PubMed 25530211Mijnarends 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.
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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.
J.M.G.A. Schols, Prof. Dr. study director
Maastricht University
R.J.G. Halfens, PhD principal investigator
Maastricht University
J.M.M. Meijers, PhD principal investigator
Maastricht University
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 Sarcopenia, 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 4 inclusion and 3 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 20 Jan 2016. 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?
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). 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 NCT01820988, 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 20 Jan 2016.