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

National Taiwan University

Status: Unknown

Conditions: Sleep Disorder; Exercise Addiction

Treatments: Other: Exercise training group

Study type: Interventional

Funder types: Other

Identifiers

NCT03005990

201512210RIND

Details and patient eligibility

About

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

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Exercise training group

Experimental group

Description:

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

Treatment:

Other: Exercise training group

Control group

No Intervention group

Description:

Control group only provide standard outpatient care program.