The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up: Body Composition and Energy Metabolism

Conditions
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Exercise Addiction, Sleep Disorder

Intervention / Treatment
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* Other: Exercise training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Community dwelling sedentary men and women who were 65 years or older Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training group<br>Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks. | Other: Exercise training group<br>* The conditioning period (24 weeks) of the exercise intervention was under the supervision of an exercise physiologist. The conditioning protocol included aerobic exercise sessions 3 times per week with 70-85% of maximal heart rate(max HR) for 30 mins and resistance sessions 3 times per week with an intensity of 80% of one-repetition maximum(1RM), 3 sets of 8 repetitions maximum. Each participant will measured the borg rating of perceived exertion scale and heart rate monitor during exercise. Exercise sessions were conducted in the afternoon (3-5 PM).<br>|
| No Intervention: Control group<br>Control group only provide standard outpatient care program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat percentage | Body fat percentage in percentage. | Up to 1 year (the first year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat mass | Body fat mass in kilograms. | Up to 1 year (the first year) | 
| Body fat free mass | Body fat free mass in kilograms. | Up to 1 year (the first year) | 
| Body mass index | BMI in kg/m^2. | Up to 1 year (the first year) | 
| Rest metabolic rate | Rest metabolic rate in percentage. | Up to 1 year (the first year) | 
| Impedance | Impedance in ohm. | Up to 1 year (the first year) | 
| Resistance | Resistance in ohm. | Up to 1 year (the first year) | 
| Electroencephalography(EEG) | Electroencephalography was assessed during sleep. | Pretest and after 24 weeks intervention (the second year) | 
| Electrooculography(EOG) | Electrooculography was assessed during sleep. | Pretest and after 24 weeks intervention (the second year) | 
| Electromyography(EMG) | Electromyography was assessed during sleep. | Pretest and after 24 weeks intervention (the second year) | 
| Electrocardiography(ECG) | Electrocardiography was assessed during sleep. | Pretest and after 24 weeks intervention (the second 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 | Triglyceride in mg/dL. | Pretest and after 24 weeks intervention (the second year) | 
| Total cholesterol | Total cholesterol in mg/dL. | Pretest and after 24 weeks intervention (the second year) | 
| Insulin | Insulin in uIU/mL. | Pretest and after 24 weeks intervention (the second year) | 
| Fasting glucose | Fasting glucose in mg/dL. | Pretest and after 24 weeks intervention (the second year) | 
| Glycated hemoglobin(HbA1C) | HbA1C in percentage. | Pretest and after 24 weeks intervention (the second year) | 
| High-density lipoprotein | High-density lipoprotein in mg/dL. | Pretest and after 24 weeks intervention (the second year) | 
| Low-density lipoprotein | Low-density lipoprotein in mg/dL. | Pretest and after 24 weeks intervention (the second year) | 
| C-reactive protein | C-reactive protein in mg/dL. | Pretest and after 24 weeks intervention (the second year) | 
| Heart rate variability | It is measured by the variation in the beat-to-beat interval. Methods used to detect beats is electrocardiography. | Pretest and after 24 weeks intervention (the second year) | 
| Maximum oxygen consumption | Use treadmill exercise testing. | Pretest and after 24 weeks intervention (the second year) | 
| Three factor eating questionnaire |  | Up to 1 year (the first year) | 
| Taiwan Geriatric Depression Scale |  | Up to 1 year (the first year) | 
| Groningen Activity Restriction Scale |  | Up to 1 year (the first year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep disturbance, Body composition, Energy metabolism, Exercise training, Community-dwelling elderly