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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01820988
Other study ID # METC 13-3-006
Secondary ID
Status Completed
Phase N/A
First received March 12, 2013
Last updated January 18, 2016
Start date May 2013
Est. completion date December 2015

Study information

Verified date April 2015
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 247
Est. completion date December 2015
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 99 Years
Eligibility 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 Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Maastricht University Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Nutricia Research Fundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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 — View Citation

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. 201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 home visit No
Secondary Prevalence of sarcopenia in community-dwelling older people 1 home visit No
Secondary Number of sarcopenic participants with frailty as a measure of the FRAIL scale and Fried criteria 1 home visit No
Secondary Health care costs by sarcopenic vs. non-sarcopenic participants, measured by health care use 1 home visit No
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