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
  Purpose

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.


Condition
Sarcopenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Reproducibility of Jumping Mechanography in Older Adults and Comparison With Current Functional Assessment Tools

Further study details as provided by University of Wisconsin, Madison:

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 96
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Men
Men over 70 years old.
Women
Women over 70 years old.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164670

Locations
United States, Wisconsin
University of Wisconsin Osteoporosis Clinical Center and Research Program
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Neil Binkley, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Neil Binkley, M.D., University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01164670     History of Changes
Other Study ID Numbers: H-2010-0011
Study First Received: July 15, 2010
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcopenia
Atrophy
Muscular Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014