An interventional study of Exercise training group in Exercise Addiction and Sleep Disorder, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-30.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's planned enrollment of 260 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.
Other: Exercise training group
Control group only provide standard outpatient care program.
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).
Body fat percentage
Body fat percentage in percentage.
Time frame: Up to 1 year (the first year)
Body fat mass
Body fat mass in kilograms.
Time frame: Up to 1 year (the first year)
Body fat free mass
Body fat free mass in kilograms.
Time frame: Up to 1 year (the first year)
Body mass index
BMI in kg/m\^2.
Time frame: Up to 1 year (the first year)
Rest metabolic rate
Rest metabolic rate in percentage.
Time frame: Up to 1 year (the first year)
Impedance
Impedance in ohm.
Time frame: Up to 1 year (the first year)
Resistance
Resistance in ohm.
Time frame: Up to 1 year (the first year)
Electroencephalography(EEG)
Electroencephalography was assessed during sleep.
Time frame: Pretest and after 24 weeks intervention (the second year)
Electrooculography(EOG)
Electrooculography was assessed during sleep.
Time frame: Pretest and after 24 weeks intervention (the second year)
Electromyography(EMG)
Electromyography was assessed during sleep.
Time frame: Pretest and after 24 weeks intervention (the second year)
Electrocardiography(ECG)
Electrocardiography was assessed during sleep.
Time frame: Pretest and after 24 weeks intervention (the second year)
Pittsburgh sleep quality index
Time frame: Up to 1 year (the first year)
Dual energy X-ray absorptiometry
Time frame: Pretest and after 24 weeks intervention (the second year)
Triglyceride
Triglyceride in mg/dL.
Time frame: Pretest and after 24 weeks intervention (the second year)
Total cholesterol
Total cholesterol in mg/dL.
Time frame: Pretest and after 24 weeks intervention (the second year)
Insulin
Insulin in uIU/mL.
Time frame: Pretest and after 24 weeks intervention (the second year)
Fasting glucose
Fasting glucose in mg/dL.
Time frame: Pretest and after 24 weeks intervention (the second year)
Glycated hemoglobin(HbA1C)
HbA1C in percentage.
Time frame: Pretest and after 24 weeks intervention (the second year)
High-density lipoprotein
High-density lipoprotein in mg/dL.
Time frame: Pretest and after 24 weeks intervention (the second year)
Low-density lipoprotein
Low-density lipoprotein in mg/dL.
Time frame: Pretest and after 24 weeks intervention (the second year)
C-reactive protein
C-reactive protein in mg/dL.
Time frame: 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.
Time frame: Pretest and after 24 weeks intervention (the second year)
Maximum oxygen consumption
Use treadmill exercise testing.
Time frame: Pretest and after 24 weeks intervention (the second year)
Three factor eating questionnaire
Time frame: Up to 1 year (the first year)
Taiwan Geriatric Depression Scale
Time frame: Up to 1 year (the first year)
Groningen Activity Restriction Scale
Time frame: Up to 1 year (the first year)
Plan to share: Undecided
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital