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

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.

• Exercise training group (Other): 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).

Primary outcomes

• Body fat percentage [Up to 1 year (the first year)]: Body fat percentage in percentage.

Secondary outcomes

• 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.
• Electrocardiography(ECG) [Pretest and after 24 weeks intervention (the second year)]: Electrocardiography 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.
• Total cholesterol [Pretest and after 24 weeks intervention (the second year)]: Total cholesterol 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.
• 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.
• Maximum oxygen consumption [Pretest and after 24 weeks intervention (the second year)]: Use treadmill exercise testing.
• 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)]

Sex: All, ages: 65 Years to any, 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

• Results publication: Tseng TH, Chen HC, Wang LY, Chien MY. Effects of exercise training on sleep quality and heart rate variability in middle-aged and older adults with poor sleep quality: a randomized controlled trial. J Clin Sleep Med. 2020 Sep 15;16(9):1483-1492. doi: 10.5664/jcsm.8560. PMID 32394890

• Meng-Yueh Chien, doctor, Study chair, National Taiwan University