Exercise Interventions During Voluntary Weight Loss in Obese Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in Physical Function
研究概览
简要总结
Obesity causes frailty in obese older adults by exacerbating the age-related decline in physical function. However, appropriate management of obesity in older adults is controversial. Weight loss without exercise could worsen frailty by accelerating the usual age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia, respectively. Because of the important problem of frailty in obese older adults, it is important to determine the most efficacious approach in reducing, or even reversing frailty in this population. The primary objective of this proposal is to evaluate which distinct type of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and reversing frailty in obese older adults.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-85 years old
- •Obese men and women (BMI > or equal to 30 kg/m2)
- •Stable weight (±2 kg) during the last 6 mos.
- •Must be sedentary (regular exercise <1 h/wk or <2 x/wk for the last 6 mos.)
- •Be judged, during the initial screening, to be well motivated and reliable
排除标准
- •Any major chronic diseases
- •Any condition or unstable diseases that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results that include but are not limited to:
- •Cardiopulmonary disease (e.g., recent MI, unstable angina, stroke etc.)
- •Severe orthopedic/musculoskeletal or neuromuscular impairments that would contraindicate participation in exercise
- •Visual or hearing impairments that interfere with following directions
- •Diagnosis of dementia
- •History of malignancy during the past 5 yr
- •Recent use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or biphosphonates during the last two years)
- •Individuals on insulin or with a fasting blood glucose of > 140mg/dl, and/or a 2 hour post-glucose of >250 mg/dl
- •BMD t-scores of <-2.3 of the lumbar spine and proximal femur
- •serum creatinine >2.0 mg/dl
- •No commitments, life situations or conditions that would interfere with their participation in the study
结局指标
主要结局
Change in Physical Function
时间窗: 6 Months
The Physical Performance Test includes seven standardized tasks (walking 15.2 m \[50 ft\], putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg test) plus two additional tasks (going up and down four flights of stairs and making a 360-degree turn). The score for each task ranges from 0 to 4, with higher scores indicating better physical performance; a perfect score would be 36.
次要结局
- Change is serum sclerostin(6 months)
- Change in adipocytokines(6 months)
- Change in 25 hydroxyvitamin D(6 months)
- Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score(6 months)
- Change in dynamic balance(6 months)
- Change in word fluency(6 months)
- Change in trail a and trail b(6 months)
- Change in fat mass(6 months)
- Change in muscle strength(6 months)
- Change in areal bone mineral density(6 months)
- Change in aerobic capacity(6 months)
- Change in serum insulin(6 months)
- Change in Medical Outcomes 36-Item short form Health survey (SF-36)(6 months)
- Change in gene expression of muscle anabolic and catabolic factors(6 months)
- Change in visceral fat mass(6 months)
- Change in gait speed(6 months)
- Change in biochemical marker for bone turnover and bone metabolism(6 months)
- Change in serum glucose(6 months)
- Change in serum lipids(6 months)
- Change in serum estradiol(6 months)
- Change in lean mass(6 months)
- Change in circulating cytokines(6 months)
- Change in systolic and diastolic blood pressure(6 months)
- Change in protein expression of muscle anabolic and catabolic factors(6 months)
- Change in habitual physical activity assessed by questionnaires(6 months)
- Change in habitual physical activity measured objectively(6 months)
- Change in concentration of targeted metabolites(6 months)
- Change in static balance(6 months)
- Change in modified mini-mental exam(6 months)
- Change in Ray Auditory verbal learning test(6 months)
- Change in muscle protein synthesis rate(6 months)
- Change in serum testosterone(6 months)
- Change in thigh muscle and fat mass(6 months)
- Change in subjective ability to function(6 months)
- Change in mood(6 months)
- Change in waist circumference(6 months)
- Change in parathyroid hormone(6 months)
研究者
Dennis Villareal
Professor of Medicine
Baylor College of Medicine