Evaluation of the Reproducibility of Jumping Mechanography

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01164670
First received: July 15, 2010
Last updated: March 15, 2011
Last verified: March 2011

July 15, 2010
March 15, 2011
May 2010
March 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01164670 on ClinicalTrials.gov Archive Site
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Evaluation of the Reproducibility of Jumping Mechanography
Evaluation of the Reproducibility of Jumping Mechanography in Older Adults and Comparison With Current Functional Assessment Tools

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Serum will be collected for measurement of laboratory studies (serum chemistries, TSH and 25[OH]D),

Non-Probability Sample

Ambulatory community dwelling adults who are able to stand without assistance. Both men and women age ≥ 70 years from the Madison Wisconsin area. Specifically, participants will be enrolled using the following strata in each gender group: low vitamin D/low functional status (12 men and 12 women), normal vitamin D/low functional status (12 men and 12 women), low vitamin D/high functional status (12 men and 12 women), and normal vitamin D/high functional status (12 men and 12 women). Low vitamin D will be defined as 25(OH)D concentrations < 25 ng/ml, normal vitamin D status will be defined as 25(OH)D concentration of 30 ng/ml or greater. Functional status will be based on screening short physical performance battery (SPPB) score dichotomized at <9 vs. 9 and above.

Sarcopenia
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  • Men
    Men over 70 years old.
  • Women
    Women over 70 years old.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
70 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01164670
H-2010-0011
No
Neil Binkley, M.D., University of Wisconsin, Madison
University of Wisconsin, Madison
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Principal Investigator: Neil Binkley, MD University of Wisconsin, Madison
University of Wisconsin, Madison
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP