Clinical trial NCT03005990: The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up
Official title: The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up: Body Composition and Energy Metabolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Addiction
Sleep Disorder
Keywords: Sleep disturbance
Body composition
Energy metabolism
Exercise training
Community-dwelling elderly
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 260
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body fat percentage
timeFrame: Up to 1 year (the first year)
Secondary outcomes:
measure: Body fat mass
timeFrame: Up to 1 year (the first year)
measure: Body fat free mass
timeFrame: Up to 1 year (the first year)
measure: Body mass index
timeFrame: Up to 1 year (the first year)
measure: Rest metabolic rate
timeFrame: Up to 1 year (the first year)
measure: Impedance
timeFrame: Up to 1 year (the first year)
measure: Resistance
timeFrame: Up to 1 year (the first year)
measure: Electroencephalography(EEG)
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Electrooculography(EOG)
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Electromyography(EMG)
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Electrocardiography(ECG)
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Pittsburgh sleep quality index
timeFrame: Up to 1 year (the first year)
measure: Dual energy X-ray absorptiometry
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Triglyceride
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Total cholesterol
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Insulin
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Fasting glucose
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Glycated hemoglobin(HbA1C)
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: High-density lipoprotein
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Low-density lipoprotein
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: C-reactive protein
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Heart rate variability
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Maximum oxygen consumption
timeFrame: Pretest and after 24 weeks intervention (the second year)
measure: Three factor eating questionnaire
timeFrame: Up to 1 year (the first year)
measure: Taiwan Geriatric Depression Scale
timeFrame: Up to 1 year (the first year)
measure: Groningen Activity Restriction Scale
timeFrame: Up to 1 year (the first year)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Meng-Yueh Chien, doctor
role: STUDY_CHAIR
References:
citation: 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.