SarcopeniaJumpNCT01164670
Evaluation of the Reproducibility of Jumping Mechanography
An observational study of Sarcopenia, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Ambulatory, community dwelling men and women age ≥ 70 years
- Able and willing to sign informed consent
- Able to stand without assistance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Osteoporosis Clinical Center and Research Program
Madison, Wisconsin, 53705
About this study
Official title: 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.
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Men | Men over 70 years old. | |
| Women | Women over 70 years old. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Binkley, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164670
- Sponsor's protocol ID
- H-2010-0011
- Acronym
- Jump
- Status last verified
- Mar 2011
- First submitted
- 15 Jul 2010
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reproducibility of Jumping Mechanography in Older Adults and Comparison With Current Functional Assessment Tools
- ClinicalTrials.gov ID
- NCT01164670
- Acronym / sponsor ID
- Jump / H-2010-0011
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | – | –Men over 70 years old. |
| Women | – | –Women over 70 years old. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Ambulatory, community dwelling men and women age ≥ 70 years
- Able and willing to sign informed consent
- Able to stand without assistance
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Binkley, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.