Clinical trial NCT02295241: Improving Muscle Assessment in Older Adults - The "Can We Build a Better Mouse Trap?" Study
Official title: Improving Muscle Assessment in Older Adults - The "Can We Build a Better Mouse Trap?" Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: Sarcopenia, muscles, aging
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 112
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will evaluate community dwelling women and men ≥ 70 years recruited from the Madison, Wisconsin area.

Brief summary: The primary aim of this study is to compare traditional muscle function tests with computerized versions using body-worn motion sensors and video motion analysis of the same tests. The investigators selected the Timed Up and Go (TUG) test as the investigators primary variable for this aim with several other function tests (e.g., repeated chair rise, 6-meter walk, 2-minute walk, Romberg stance, semi-tandem / tandem stance) as secondary variables. The investigators primary hypothesis is that the computerized versions of the TUG test are highly correlated (\>0.9) with the traditional method, but with comparable or better reproducibility. Secondary analyses will correlate other function tests with their computerized version, again with the hypothesis that they are highly correlated and that computerized versions are of similar or better reproducibility. This analysis will also compare traditional assessments of balance with a computerized balance method, computerized dynamic posturography.


Eligibility criteria: Inclusion Criteria:

1. Ambulatory, community dwelling men and women age ≥ 70 years
2. Able and willing to sign informed consent
3. Able to stand without assistance

Exclusion Criteria:

1. History of myocardial infarction within the prior six months or ongoing angina
2. History of injury or surgery within the prior six months which limits the ability to ambulate
3. History of malignancy with metastasis to the musculoskeletal system
4. Neuromuscular disease or severe end organ disease impairing balance or muscle function to the degree that completion of all study tests is unlikely.

Primary outcomes:
measure: The comparison of results of traditional physical function tests with the results of computerized versions (body worn sensors and Kinect system) of the same tests.
timeFrame: All physical function tests will be performed at the first visit and visit 2 up to 4 days later
Secondary outcomes:
measure: Explore the capabilities of the Microsoft Kinect system to record and analyze muscle function tests and correlate the Microsoft Kinect system to a gold standard motion analysis system.
timeFrame: All physical function tests will be performed at the first visit and visit 2 up to 4 days later.
measure: Validate the use of BIS (Bioelectrical Impedance Spectroscopy) to adjust DXA (Dual Energy X-ray Absorptiometry) -measured body composition by providing muscle mass measurement
timeFrame: BIS is performed at visit 1 and visit 2 up to 4 days later. DXA is performed at visit 2.
measure: Correlate various ratios of lean or muscle mass / DXA measured fat mass with functional tests.
timeFrame: All physical function tests will be performed at the screen and follow up visits.
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison Osteoporosis Clinical Research Program
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Neil Binkley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: