- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02295241
Improving Muscle Assessment in Older Adults - The "Can We Build a Better Mouse Trap?" Study
March 25, 2016 updated by: University of Wisconsin, Madison
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin-Madison Osteoporosis Clinical Research Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will evaluate community dwelling women and men ≥ 70 years recruited from the Madison, Wisconsin area.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Short-term reproducibility of traditional vs. computerized functional tests will also be compared.
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All physical function tests will be performed at the first visit and visit 2 up to 4 days later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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All physical function tests will be performed at the first visit and visit 2 up to 4 days later.
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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.
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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.
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BIS is performed at visit 1 and visit 2 up to 4 days later. DXA is performed at visit 2.
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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.
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All physical function tests will be performed at the screen and follow up visits.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
October 3, 2014
First Submitted That Met QC Criteria
November 14, 2014
First Posted (Estimate)
November 20, 2014
Study Record Updates
Last Update Posted (Estimate)
March 28, 2016
Last Update Submitted That Met QC Criteria
March 25, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-1109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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