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

Not Applicable

• Conditions: Exercise Addiction; Sleep Disorder
• Interventions: Other: Exercise training group

• Registration Number: NCT03005990
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study First Posted: 2016-12-30
• Last Update Posted: 2016-12-30
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Community dwelling sedentary men and women who were 65 years or older

Exclusion Criteria

1. 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
2. History of cognitive or other neurological disorders
3. 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
4. Unstable or serious medical conditions or cardiopulmonary disease that contraindicate exercise
5. BMI > 35 kg/m2
6. Individual with a life expectancy of no more than 1 years or final stage of cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training group	Exercise training group	Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Body fat percentage	Up to 1 year (the first year)	Body fat percentage in percentage.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University; 🇨🇳 Taipei, Taiwan