Effects of a Resistance Training Program in Older Women With Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Muscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared)
研究概览
简要总结
This is a randomized clinical trial with a control group that will test how periodized resistance training will impact measures of sarcopenia in older women who have been identified as presarcopenic or sarcopenic. The intervention will be approximately 12 weeks in duration with 24 total free-living older women. Outcome measures will be collected at baseline, 6 weeks and post-intervention.
详细描述
New sarcopenia (i.e. the age-related loss of muscle mass) guidelines established in 2014 recommend identifying older individuals for interventions who have low muscle strength and/or gait speed as these functional measures are associated with low muscle mass and subsequent negative health consequences such as increased mortality risk. Moreover, consensus guidelines indicate that more research, especially in older women, needs to be conducted to test the efficacy of periodized (i.e. planned variations in the program) resistance exercise training (RT) protocols in individuals who have been identified as sarcopenic or at risk of sarcopenia. Our interdisciplinary research group has conducted and published the results of several intervention studies in older adults and would like to expand this line of research to fill a critical gap in the current research. The broad objective of this research project is to help determine the efficacy of a periodized RT intervention strategy to treat sarcopenia or presarcopenia and its correlates among older women. The specific primary aim is to determine if there is significant effect of a RT program for improving physical functioning and muscle mass in older women. Exploratory aims are determine the impact of the RT intervention on other measures including bone density, lipoproteins, and other health indicators. The long-term goal of this project is to generate essential data for the submission of a more comprehensive NIH or private agency grant. The research design will be a randomized trial with a control group and methodology of this study will include 25 community-dwelling older women (age 65-84 years) for a 12-week repeated measures (baseline, 6 week, and post) randomized study with a six month observational follow-up. After baseline testing, participants will be randomized to either a RT intervention group (RTI) or to an active control (CON) group. The RT intervention will take place three times per week on non-consecutive days using 8-10 exercises for major muscle groups utilizing free weights and machines follow American College of Sports Medicine and National Strength and Conditioning Association guidelines for RT in older adults. The CON group will meet three times weekly for light physical activity and stretching. The relevance of this research is very significant as no studies to date have specifically examined RT in older women who have been identified as sarcopenic or presarcopenic using newly established guidelines. This study will accept all potential participants meeting inclusion criteria, regardless of ethnic, racial, or religious backgrounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, aged 65-84 years;
- •Low lean mass and/or low physical functioning based on current guidelines;
- •Currently (≥ 6 months) not engaged in a regular exercise program;
- •Post-menopausal by self-report.
排除标准
- •Failure to provide informed consent;
- •Significant or suspected cognitive impairment;
- •Severe hearing loss, speech disorder, language barrier or visual impairment;
- •Progressive, degenerative neurologic disease;
- •Terminal illness with life expectancy of < 12 months, as determined by a physician;
- •Severe pulmonary disease, uncontrolled diabetes, blood pressure, or anemia;
- •Medications not taken for > 3 weeks, lipid lowering medications for > 6 months;
- •Major joint, vascular, abdominal, or thoracic surgery within six months;
- •Significant cardiovascular disease or implanted pacemaker/defibrillator;
- •Inability to safely engage in mild to moderate exercise with muscular exertion.
结局指标
主要结局
Muscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared)
时间窗: 12 weeks
Overall body composition was estimated using dual-energy x-ray absorptiometry (DXA) using fan-beam technology on a GE Lunar iDXA machine (GE, Waukesha, WI). Participants reported to testing in a fasted state (\~12 hours) and wore surgical scrubs during the test. Standardized positioning procedures were followed and a licensed radiology technician performed all tests. Appendicular lean mass, total body fat mass, and percent fat were measured. Appendicular lean mass was considered the sum of non-bone lean mass in both arms and legs. Total body lean mass was defined as lean soft tissue mass plus total body bone mineral content.
次要结局
- Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry(12 weeks)
- Grip Strength Change: From Hand Grip Dynamometry in kg(6 weeks, 12 weeks, and six month follow-up)
- Chair Stand Ability: Ability to Rise From a Chair One Time - Yes or No(Baseline)
- Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair(6 weeks, 12 weeks, and six month follow-up)
- Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position(12 weeks)
- Physical Functioning Change: Normal Gait Speed Time From 400-meter Walk(6 weeks, 12 weeks, and six month follow-up)
- Muscle Strength Change: Leg Press One-repetition Maximum in kg(6 weeks, 12 weeks, and six month follow-up)
- Sarcopenia Status Change(12 weeks)
- Balance Ability: Single-leg Stand. Scored Yes or No(12 weeks)
研究者
Matthew J. Delmonico, PhD, MPH
Associate Professor
University of Rhode Island