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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295241
• Other study ID #: 2014-1109
• Status: Completed
• Phase: N/A
• First received: October 3, 2014
• Last updated: March 25, 2016
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• No intervention
This is an observational trial, no interventions are being used.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison Osteoporosis Clinical Research Program	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	Validate the use of BIS (Bioelectrical Impedance Spectroscopy) to adjust DXA (Dual Energy X-ray Absorptiometry) -measured body composition by providing muscle mass measurement	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.	BIS is performed at visit 1 and visit 2 up to 4 days later. DXA is performed at visit 2.	No
Secondary	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.	No