NCT01820988

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

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

First Submitted

Initial submission to the registry

March 12, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

March 12, 2013

Last Update Submit

January 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Prevalence of sarcopenia in community-dwelling older people

    1 home visit

  • Number of sarcopenic participants with frailty as a measure of the FRAIL scale and Fried criteria

    1 home visit

  • Health care costs by sarcopenic vs. non-sarcopenic participants, measured by health care use

    1 home visit

Study Arms (1)

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).

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Community-dwelling older people

You may qualify if:

  • ≥ 65 years old
  • Have given informed consent
  • Understand Dutch language
  • Able to perform a walk test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Related 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: 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • J.M.G.A. Schols, Prof. Dr.

    Maastricht University

    STUDY DIRECTOR
  • R.J.G. Halfens, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR
  • J.M.M. Meijers, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR
  • D.M. Mijnarends, MSc

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 29, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Study Completion

December 1, 2015

Last Updated

January 20, 2016

Record last verified: 2015-04

Locations