The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up: Body Composition and Energy Metabolism
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Body fat percentage
研究概览
简要总结
This study will explore the long-term effects of exercise training on body composition, cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with sleep disturbances
详细描述
This project will be conducted in three years:
In the first year,investigators will explore the correlation of sleep parameters, dietary behavior and body composition in community-dwelling elders. Two hundred elders will be recruited to receive the actigraph accelerometer recording, sleep quality questionnaire, bio-electrical impedance analysis, heart rate variability analysis, cognitive and depression evaluation.
Secondly, the study will evaluate the efficacy and possible mechanisms of a 24-week exercise training for sleep disturbances patients. Sixty patients with sleep disturbances elders will be randomized to exercise group or control group. Participants in the exercise group will receive aerobic and resistance exercise 3 times per week for 24 weeks. The controls will receive sleep hygiene education and consultation. All measurements will be performed as described before.
Finally, all the 260 elders participating in this study will receive 12-month follow-up assessments to explore the longitudinal impact of sleep disturbances on cardiorespiratory function, body composition and metabolic function, and long-term effect of exercise training on sleep disturbances patients. Investigators expect elders with poor sleep quality have lower level of health-related fitness and metabolic function; exercise training is effective to improve sleep quality, metabolic function and general health in the elders with sleep disturbances, and the effect can be sustained for a long period.
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 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community dwelling sedentary men and women who were 65 years or older
排除标准
- •History of Diagnostic and Statistical Manual Diploma in Social Medicine, 4th. Edition (DSM-IV) criteria for any major psychiatric disorder, including mania or alcohol or substance abuse
- •History of cognitive or other neurological disorders
- •Other sleep disorders by history or documented on screening polysomnography (apnea index >10, periodic leg movement arousal index >15, or rapid eye movement (REM) behavior disorder
- •Unstable or serious medical conditions or cardiopulmonary disease that contraindicate exercise
- •BMI > 35 kg/m2
- •Individual with a life expectancy of no more than 1 years or final stage of cancer
研究组 & 干预措施
Exercise training group
Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.
干预措施: Exercise training group (Other)
Control group
Control group only provide standard outpatient care program.
结局指标
主要结局
Body fat percentage
时间窗: Up to 1 year (the first year)
Body fat percentage in percentage.
次要结局
- Impedance(Up to 1 year (the first year))
- Maximum oxygen consumption(Pretest and after 24 weeks intervention (the second year))
- Body fat mass(Up to 1 year (the first year))
- Rest metabolic rate(Up to 1 year (the first year))
- Electroencephalography(EEG)(Pretest and after 24 weeks intervention (the second year))
- Electrooculography(EOG)(Pretest and after 24 weeks intervention (the second year))
- Electromyography(EMG)(Pretest and after 24 weeks intervention (the second year))
- Electrocardiography(ECG)(Pretest and after 24 weeks intervention (the second year))
- Total cholesterol(Pretest and after 24 weeks intervention (the second year))
- Three factor eating questionnaire(Up to 1 year (the first year))
- Body fat free mass(Up to 1 year (the first year))
- Body mass index(Up to 1 year (the first year))
- Resistance(Up to 1 year (the first year))
- Pittsburgh sleep quality index(Up to 1 year (the first year))
- Dual energy X-ray absorptiometry(Pretest and after 24 weeks intervention (the second year))
- Triglyceride(Pretest and after 24 weeks intervention (the second year))
- Insulin(Pretest and after 24 weeks intervention (the second year))
- Fasting glucose(Pretest and after 24 weeks intervention (the second year))
- Glycated hemoglobin(HbA1C)(Pretest and after 24 weeks intervention (the second year))
- High-density lipoprotein(Pretest and after 24 weeks intervention (the second year))
- Low-density lipoprotein(Pretest and after 24 weeks intervention (the second year))
- C-reactive protein(Pretest and after 24 weeks intervention (the second year))
- Heart rate variability(Pretest and after 24 weeks intervention (the second year))
- Taiwan Geriatric Depression Scale(Up to 1 year (the first year))
- Groningen Activity Restriction Scale(Up to 1 year (the first year))