An observational study in Sarcopenia, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-09.
Sponsored by University of Florida · Observational
Due to the rapid aging of the population, sarcopenia is among the greatest challenges facing the health care system over the next quarter century. This age-related loss of skeletal muscle mass and strength directly contributes to the incidence of functional disability, thereby reducing independence and quality of life for the elderly. Despite increasing efforts to combat sarcopenia, its etiology remains incompletely described. Subsequently, limited progress has been made in developing comprehensive preventative and therapeutic strategies to combat the problem. A decreased ability to regenerate skeletal muscle fibers through the donation of skeletal muscle stem cells (satellite cells) is thought to contribute to sarcopenia. However, the upstream physiological mediators that regulate this impairment are poorly delineated.
Reduced muscle blood flow in advanced age appears to be a significant factor in reducing skeletal muscle regenerative capacity, but few data exist to confirm this hypothesis. Thus to test this hypothesis we aim to conduct a translational pilot trial which examines regeneration in both young and old adults. Furthermore, we aim to determine if muscle blood flow and satellite cell number are associated with muscle function. The central hypothesis of this proposal is that age-related declines in skeletal muscle angiogenesis and perfusion are significant causal factors in age-related losses of skeletal muscle mass. The specific aims and hypotheses of the project are as follows:
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 68 is below the median of 120 across 419 observational studies indexed under Sarcopenia.
Browse Sarcopenia studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Community Sample
Exclusion Criteria:
Healthy Men and Women Over 70 Years of Age
Healthy Men and Women Aged 18-30 Years
Muscle Satellite Cells
Change in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.
Time frame: Baseline, 2 days post-injury, 7 days post-injury
From September 2010 through December 2011, community-dwelling persons were recruited to participate through a variety of methods including media articles, direct mailings, newspaper announcements, and presentations to community groups.
| Milestone | Older Adults | Young Adults |
|---|---|---|
| Started | 39 | 29 |
| Completed | 15 | 15 |
| Not completed | 24 | 14 |
| Withdrew: Lost to follow-up | 0 | 7 |
| Withdrew: Did not quality after 2nd screening | 14 | 1 |
| Withdrew: Withdrawal by subject | 8 | 6 |
| Withdrew: Physician decision | 2 | 0 |
Change in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.
| Number of Pax7+ cells/muscle fiber | Older Adults | Young Adults |
|---|---|---|
| Adjusted Baseline | 3.2 ± 0.0 | 3.2 ± 0.0 |
| Adjusted 2 days post-injury | 4.0 ± .4 | 3.8 ± 0.4 |
| Adjusted 7 days post-injury | 4.0 ± 0.3 | 3.7 ± 0.3 |
Collected over 14 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Younger Adults | — | 0/29 (0%) | 6/29 (20.7%) |
| Older Adults | — | 2/39 (5.1%) | 7/39 (17.9%) |
| Event | Younger Adults | Older Adults |
|---|---|---|
| Myocardial InfarctionCardiac disorders | 0/29 | 1/39 |
| HospitalizationBlood and lymphatic system disorders | 0/29 | 1/39 |
| Event | Younger Adults | Older Adults |
|---|---|---|
| Pain/BruisingGeneral disorders | 4/29 | 1/39 |
| Skeletal Muscle SorenessMusculoskeletal and connective tissue disorders | 0/29 | 4/39 |
| DermatitisSkin and subcutaneous tissue disorders | 1/29 | 0/39 |
| Broken ToeMusculoskeletal and connective tissue disorders | 1/29 | 0/39 |
| Mild swellingGeneral disorders | 1/29 | 0/39 |
| Muscle SpasmsMusculoskeletal and connective tissue disorders | 0/29 | 1/39 |
| Atrial FibrillationCardiac disorders | 0/29 | 1/39 |
| Minor RashSkin and subcutaneous tissue disorders | 0/29 | 1/39 |
| Age, Categorical(Participants) | Older Adults | Young Adults | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 29 | 29 |
| >=65 years | 39 | 0 | 39 |
| Sex: Female, Male(Participants) | Older Adults | Young Adults | Total |
|---|---|---|---|
| Female | 15 | 11 | 26 |
| Male | 24 | 18 | 42 |
| Region of Enrollment(participants) | Older Adults | Young Adults | Total |
|---|---|---|---|
| United States | 39 | 29 | 68 |
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Florida