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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01164670
Other study ID # H-2010-0011
Secondary ID
Status Completed
Phase N/A
First received July 15, 2010
Last updated October 1, 2015
Start date May 2010
Est. completion date March 2011

Study information

Verified date March 2011
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

Sarcopenia, the age-related decline in muscle mass and function (widely recognized as "frailty"), is increasingly being appreciated, primarily in the research environment. Interventions to prevent or treat sarcopenia can be anticipated to reduce falls, fractures and thereby to facilitate independence and improve quality of life for older adults. Unfortunately, there is no current consensus definition of sarcopenia, thereby impeding clinical recognition and treatment. It has been advocated that low appendicular (arm and leg) lean mass, as measured by DXA, be utilized as a clinical diagnostic tool to define sarcopenia. While such an approach is possible, however, muscle strength loss is more rapid than mass loss, indicating deterioration of muscle "quality." Muscle quality may be affected by changes at the neuromuscular, cellular or subcellular levels; parameters not detected by measuring mass alone. Clearly, tools evaluating muscle performance, not simply mass, are needed to optimally identify, and subsequently monitor, treatment of older adults with sarcopenia. While current tests of muscle power/function (e.g., chair-rising, self-selected gait velocity, etc.) do correlate with functional limitation in older adults, these existing tests have limitations in that they cannot be performed in all people, may have "yes/no" results rather than a continuous scale and may not be highly precise. Thus, improved muscle function assessment tools are needed, both clinically and in research venues. Jumping mechanography is very likely one such methodology.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 70 Years and older
Eligibility 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:

- Abnormalities on screening laboratory assessment deemed to be clinically significant by the study investigators

- 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 severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study

- History of malignancy with metastasis to the musculoskeletal system

- Neuromuscular disease impairing balance to the degree of not being able to stand without assistance

- BMD T-score of less than -3.5 at any measured site and a prior hip or vertebral fracture

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

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