- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02295241
Improving Muscle Assessment in Older Adults - The "Can We Build a Better Mouse Trap?" Study
25. marts 2016 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
112
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconsin-Madison Osteoporosis Clinical Research Program
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
70 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
This study will evaluate community dwelling women and men ≥ 70 years recruited from the Madison, Wisconsin area.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2015
Primær færdiggørelse (Faktiske)
1. oktober 2015
Studieafslutning (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først indsendt
3. oktober 2014
Først indsendt, der opfyldte QC-kriterier
14. november 2014
Først opslået (Skøn)
20. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014-1109
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