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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2020

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

  • Other: Exercise training group
    • 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).

Arms, Groups and Cohorts

  • Experimental: Exercise training group
    • Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.
  • No Intervention: Control group
    • Control group only provide standard outpatient care program.

Clinical Trial Outcome Measures

Primary Measures

  • Body fat percentage
    • Time Frame: Up to 1 year (the first year)
    • Body fat percentage in percentage.

Secondary Measures

  • Body fat mass
    • Time Frame: Up to 1 year (the first year)
    • Body fat mass in kilograms.
  • Body fat free mass
    • Time Frame: Up to 1 year (the first year)
    • Body fat free mass in kilograms.
  • Body mass index
    • Time Frame: Up to 1 year (the first year)
    • BMI in kg/m^2.
  • Rest metabolic rate
    • Time Frame: Up to 1 year (the first year)
    • Rest metabolic rate in percentage.
  • Impedance
    • Time Frame: Up to 1 year (the first year)
    • Impedance in ohm.
  • Resistance
    • Time Frame: Up to 1 year (the first year)
    • Resistance in ohm.
  • Electroencephalography(EEG)
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Electroencephalography was assessed during sleep.
  • Electrooculography(EOG)
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Electrooculography was assessed during sleep.
  • Electromyography(EMG)
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Electromyography was assessed during sleep.
  • Electrocardiography(ECG)
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Electrocardiography was assessed during sleep.
  • 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
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Triglyceride in mg/dL.
  • Total cholesterol
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Total cholesterol in mg/dL.
  • Insulin
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Insulin in uIU/mL.
  • Fasting glucose
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Fasting glucose in mg/dL.
  • Glycated hemoglobin(HbA1C)
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • HbA1C in percentage.
  • High-density lipoprotein
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • High-density lipoprotein in mg/dL.
  • Low-density lipoprotein
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Low-density lipoprotein in mg/dL.
  • C-reactive protein
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • C-reactive protein in mg/dL.
  • Heart rate variability
    • Time Frame: 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
    • Time Frame: Pretest and after 24 weeks intervention (the second year)
    • Use treadmill exercise testing.
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Meng-Yueh Chien, doctor, Study Chair, National Taiwan University

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