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

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

Study Overview

• Status: Unknown
• Conditions: Sleep Disorder; Exercise Addiction
• Intervention / Treatment: Other: Exercise training group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise training group; Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.	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).
No Intervention: Control group; Control group only provide standard outpatient care program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat percentage	Body fat percentage in percentage.	Up to 1 year (the first year)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Meng-Yueh Chien, doctor, National Taiwan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Estimate): December 30, 2016
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Body composition; Exercise training; Sleep disturbance; Energy metabolism; Community-dwelling elderly
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 201512210RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided