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OpenTrials
Completed

NCT Number: NCT02295241

Improving Muscle Assessment in Older Adults - The "Can We Build a Better Mouse Trap?" Study

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin-Madison Osteoporosis Clinical Research Program

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

This is an observational trial, no interventions are being used.

Primary outcomes

  1. 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.

    Time frame: All physical function tests will be performed at the first visit and visit 2 up to 4 days later

    Short-term reproducibility of traditional vs. computerized functional tests will also be compared.

Secondary outcomes

  1. 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.

    Time frame: All physical function tests will be performed at the first visit and visit 2 up to 4 days later.

  2. Validate the use of BIS (Bioelectrical Impedance Spectroscopy) to adjust DXA (Dual Energy X-ray Absorptiometry) -measured body composition by providing muscle mass measurement

    Time frame: BIS is performed at visit 1 and visit 2 up to 4 days later. DXA is performed at visit 2.

    The relationship of lean mass, as estimated by DXA and BIS with muscle mass as measured by deuterated creatine dilution as a nominal gold standard. Additionally, the correlation of lean mass as measured by DXA and muscle mass as measured by BIS and creatine dilution with muscle function tests.

  3. Correlate various ratios of lean or muscle mass / DXA measured fat mass with functional tests.

    Time frame: All physical function tests will be performed at the screen and follow up visits.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2014
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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