Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 6
- 主要终点
- Change from Baseline in Sonographic Lean Body Mass at 3 months
研究概览
简要总结
The objectives of this study are to: 1) validate a rapid, portable, cost-effective method for screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a novel approach to progressive resistance exercise involving eccentric muscle actions that will counter the local effects of myosteatosis and sarcopenia in African Americans.
详细描述
The rationale for this study is the need to proactively address health disparities associated with age-related skeletal muscle dysfunction. Age-related changes in muscle may be characterized by sarcopenia (i.e., loss of muscle mass) and/or myosteatosis (i.e., excessive intramuscular adipose tissue). These changes may result in physical impairments that may be exacerbated by the lack of a formal screening and diagnosis process for older adults in standard healthcare settings. Myosteatosis may compound the effects of sarcopenia and play a significant role the age-related functional decline and higher incidence of type 2 diabetes observed in African Americans in comparison to other ethnic/racial groups. The initial phase of the study will involve the assessment of older African Americans (n = 70) to characterize muscle size and quality in comparison to a younger reference group (n = 70). Participants randomly selected from the older subject pool will be assigned to either the Eccentric Exercise Group or the Concentric Exercise Group for 12 weeks of a supervised strengthening exercise regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An African American adult.
- •Between 18 and 30 years of age, or between 65 and 85 years of age.
- •Able to independently walk at home and in your community (use of an assistive device like a cane or a walker is acceptable).
排除标准
- •Uncontrolled hypertension or other cardiovascular disease.
- •A Body Mass Index of 32.5 or above may be an exclusion criterion if the X-ray technician determines that dimensions of the scanning bed are not adequate for a reliable examination.
- •A musculoskeletal condition that would stop you from performing the physical assessment tests.
- •Muscle weakness due to neurological disease or injury (such as stroke or spinal cord injury).
- •Moderate to severe sepsis (blood infection) or edema (such as swelling of a limb).
- •Been hospitalized over the last three months.
- •History of a broken arm or leg bone because of osteoporosis.
结局指标
主要结局
Change from Baseline in Sonographic Lean Body Mass at 3 months
时间窗: At study baseline for all subjects, and at Week 6 and 12 of the intervention period for subjects randomly assigned to an exercise group
US estimates of aggregate regional LBM (muscle thickness, cm), will be assessed using B-mode diagnostic US with a 13-6 megahertz (MHz) linear array transducer for morphology measures at 6 axial and appendicular sites.
次要结局
- Change from Baseline in dual-energy X-ray absorptiometry (DXA) scanning at 3 months(At study baseline for all subjects, and at Week 12 of the intervention period for subjects randomly assigned to an exercise group)
- Change from Baseline in metabolic status at 3 months(At study baseline for all subjects)
- Change from Baseline in intramuscular adipose tissue assessment at 3 months(At study baseline for all subjects)
- Change from Baseline in strength assessment at 3 months(At study baseline for all subjects, and at Week 6 and 12 of the intervention period for subjects randomly assigned to an exercise group)