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

The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up: Body Composition and Energy Metabolism

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03005990
Enrollment
260
Registered
2016-12-30
Start date
2016-12-31
Completion date
2020-01-31
Last updated
2016-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Addiction, Sleep Disorder

Keywords

Sleep disturbance, Body composition, Energy metabolism, Exercise training, Community-dwelling elderly

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.

Interventions

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).

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body fat percentageUp to 1 year (the first year)Body fat percentage in percentage.

Secondary

MeasureTime frameDescription
Body fat free massUp to 1 year (the first year)Body fat free mass in kilograms.
Body mass indexUp to 1 year (the first year)BMI in kg/m\^2.
Rest metabolic rateUp to 1 year (the first year)Rest metabolic rate in percentage.
ImpedanceUp to 1 year (the first year)Impedance in ohm.
ResistanceUp 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 indexUp to 1 year (the first year)
Dual energy X-ray absorptiometryPretest and after 24 weeks intervention (the second year)
TriglyceridePretest and after 24 weeks intervention (the second year)Triglyceride in mg/dL.
Body fat massUp to 1 year (the first year)Body fat mass in kilograms.
InsulinPretest and after 24 weeks intervention (the second year)Insulin in uIU/mL.
Fasting glucosePretest 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 lipoproteinPretest and after 24 weeks intervention (the second year)High-density lipoprotein in mg/dL.
Low-density lipoproteinPretest and after 24 weeks intervention (the second year)Low-density lipoprotein in mg/dL.
C-reactive proteinPretest and after 24 weeks intervention (the second year)C-reactive protein in mg/dL.
Heart rate variabilityPretest 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 consumptionPretest and after 24 weeks intervention (the second year)Use treadmill exercise testing.
Three factor eating questionnaireUp to 1 year (the first year)
Taiwan Geriatric Depression ScaleUp to 1 year (the first year)
Groningen Activity Restriction ScaleUp to 1 year (the first year)
Total cholesterolPretest and after 24 weeks intervention (the second year)Total cholesterol in mg/dL.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026