SarcopeniaNCT02295241
Improving Muscle Assessment in Older Adults - The "Can We Build a Better Mouse Trap?" Study
An observational study of Sarcopenia, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This study will evaluate community dwelling women and men ≥ 70 years recruited from the Madison, Wisconsin area.
Who may be able to join
- Ambulatory, community dwelling men and women age ≥ 70 years
- Able and willing to sign informed consent
- Able to stand without assistance
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison Osteoporosis Clinical Research Program
Madison, Wisconsin, 53705
About this 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.
- Conditions
- Sarcopenia
- Being tested
- No intervention
- Keywords
- Sarcopenia, muscles, aging
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational trial, no interventions are being used.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: All physical function tests will be performed at the screen and follow up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Binkley, M.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295241
- Sponsor's protocol ID
- 2014-1109
- Status last verified
- Mar 2016
- First submitted
- 3 Oct 2014
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Muscle Assessment in Older Adults - The "Can We Build a Better Mouse Trap?" Study
- ClinicalTrials.gov ID
- NCT02295241
- Acronym / sponsor ID
- 2014-1109
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, muscles, aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study will evaluate community dwelling women and men ≥ 70 years recruited from the Madison, Wisconsin area.
Key inclusion criteria (3 listed)
- Ambulatory, community dwelling men and women age ≥ 70 years
- Able and willing to sign informed consent
- Able to stand without assistance
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational trial, no interventions are being used. | Other | – |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Binkley, M.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: All physical function tests will be performed at the first visit and visit 2 up to 4 days later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.