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

NCT02295241 | Completed

• 1 other identifier: 2014-1109
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia, muscles, aging

Outcome Measures

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.

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

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

Secondary Outcomes (3)

• 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.

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

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

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

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

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

Interventions

No intervention OTHER

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will evaluate community dwelling women and men ≥ 70 years recruited from the Madison, Wisconsin area.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison Osteoporosis Clinical Research Program

Madison, Wisconsin, 53705, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be drawn to obtain a serum chemistry panel to document health status of the study participants. For subjects who agree to optional banking, serum aliquots will be obtained and banked for future study of markers relevant to musculoskeletal health.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Neil Binkley, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: November 20, 2014
• Study Start: February 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 28, 2016

Record last verified: 2016-03

Locations

US (1)