- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164670
Evaluation of the Reproducibility of Jumping Mechanography (Jump)
October 1, 2015 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
96
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin Osteoporosis Clinical Center and Research Program
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Men
Men over 70 years old.
|
|
Women
Women over 70 years old.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Binkley, MD, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
July 15, 2010
First Submitted That Met QC Criteria
July 15, 2010
First Posted (Estimate)
July 19, 2010
Study Record Updates
Last Update Posted (Estimate)
October 5, 2015
Last Update Submitted That Met QC Criteria
October 1, 2015
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2010-0011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcopenia
-
University Hospital, BonnRecruiting
-
Shanghai Yueyang Integrated Medicine HospitalShanghai University of Traditional Chinese Medicine; DongE E Jiao Coporation... and other collaboratorsNot yet recruiting
-
Cairo UniversityNot yet recruitingGeriatric SarcopeniaEgypt
-
TNF Pharmaceuticals, Inc.Not yet recruitingFrailty | Sarcopenia in Elderly | Frailty/Sarcopenia | Frailty in Older Adults
-
Assiut UniversityNot yet recruiting
-
University of ExtremaduraCompletedSarcopenia in Elderly | Institutionalized Older Adults | HIITSpain
-
Animuscure Inc.Recruiting
-
West China HospitalNot yet recruitingSarcopenia in Elderly
-
Centre Hospitalier Universitaire DijonCompleted
-
University of Texas at AustinNot yet recruitingExercise Training and SarcopeniaUnited States