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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03005990
• Other study ID #: 201512210RIND
• Status: Active, not recruiting
• Phase: N/A
• First received: December 13, 2016
• Last updated: December 29, 2016
• Start date: December 2016
• Est. completion date: January 2020

Study information

• Verified date: December 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Exercise Addiction
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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).

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fat percentage	Body fat percentage in percentage.	Up to 1 year (the first year)	No
Secondary	Body fat mass	Body fat mass in kilograms.	Up to 1 year (the first year)	No
Secondary	Body fat free mass	Body fat free mass in kilograms.	Up to 1 year (the first year)	No
Secondary	Body mass index	BMI in kg/m^2.	Up to 1 year (the first year)	No
Secondary	Rest metabolic rate	Rest metabolic rate in percentage.	Up to 1 year (the first year)	No
Secondary	Impedance	Impedance in ohm.	Up to 1 year (the first year)	No
Secondary	Resistance	Resistance in ohm.	Up to 1 year (the first year)	No
Secondary	Electroencephalography(EEG)	Electroencephalography was assessed during sleep.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Electrooculography(EOG)	Electrooculography was assessed during sleep.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Electromyography(EMG)	Electromyography was assessed during sleep.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Electrocardiography(ECG)	Electrocardiography was assessed during sleep.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Pittsburgh sleep quality index		Up to 1 year (the first year)	No
Secondary	Dual energy X-ray absorptiometry		Pretest and after 24 weeks intervention (the second year)	No
Secondary	Triglyceride	Triglyceride in mg/dL.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Total cholesterol	Total cholesterol in mg/dL.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Insulin	Insulin in uIU/mL.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Fasting glucose	Fasting glucose in mg/dL.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Glycated hemoglobin(HbA1C)	HbA1C in percentage.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	High-density lipoprotein	High-density lipoprotein in mg/dL.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Low-density lipoprotein	Low-density lipoprotein in mg/dL.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	C-reactive protein	C-reactive protein in mg/dL.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	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)	No
Secondary	Maximum oxygen consumption	Use treadmill exercise testing.	Pretest and after 24 weeks intervention (the second year)	No
Secondary	Three factor eating questionnaire		Up to 1 year (the first year)	No
Secondary	Taiwan Geriatric Depression Scale		Up to 1 year (the first year)	No
Secondary	Groningen Activity Restriction Scale		Up to 1 year (the first year)	No