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

Primary Purpose

Exercise Addiction, Sleep Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise training group
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Addiction focused on measuring Sleep disturbance, Body composition, Energy metabolism, Exercise training, Community-dwelling elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training group

Control group

Arm Description

Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.

Control group only provide standard outpatient care program.

Outcomes

Primary Outcome Measures

Body fat percentage
Body fat percentage in percentage.

Secondary Outcome Measures

Body fat mass
Body fat mass in kilograms.
Body fat free mass
Body fat free mass in kilograms.
Body mass index
BMI in kg/m^2.
Rest metabolic rate
Rest metabolic rate in percentage.
Impedance
Impedance in ohm.
Resistance
Resistance in ohm.
Electroencephalography(EEG)
Electroencephalography was assessed during sleep.
Electrooculography(EOG)
Electrooculography was assessed during sleep.
Electromyography(EMG)
Electromyography was assessed during sleep.
Electrocardiography(ECG)
Electrocardiography was assessed during sleep.
Pittsburgh sleep quality index
Dual energy X-ray absorptiometry
Triglyceride
Triglyceride in mg/dL.
Total cholesterol
Total cholesterol in mg/dL.
Insulin
Insulin in uIU/mL.
Fasting glucose
Fasting glucose in mg/dL.
Glycated hemoglobin(HbA1C)
HbA1C in percentage.
High-density lipoprotein
High-density lipoprotein in mg/dL.
Low-density lipoprotein
Low-density lipoprotein in mg/dL.
C-reactive protein
C-reactive protein in mg/dL.
Heart rate variability
It is measured by the variation in the beat-to-beat interval. Methods used to detect beats is electrocardiography.
Maximum oxygen consumption
Use treadmill exercise testing.
Three factor eating questionnaire
Taiwan Geriatric Depression Scale
Groningen Activity Restriction Scale

Full Information

First Posted
December 13, 2016
Last Updated
December 29, 2016
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03005990
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Addiction, Sleep Disorder
Keywords
Sleep disturbance, Body composition, Energy metabolism, Exercise training, Community-dwelling elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise training group
Arm Type
Experimental
Arm Description
Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group only provide standard outpatient care program.
Intervention Type
Other
Intervention Name(s)
Exercise training group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Body fat percentage
Description
Body fat percentage in percentage.
Time Frame
Up to 1 year (the first year)
Secondary Outcome Measure Information:
Title
Body fat mass
Description
Body fat mass in kilograms.
Time Frame
Up to 1 year (the first year)
Title
Body fat free mass
Description
Body fat free mass in kilograms.
Time Frame
Up to 1 year (the first year)
Title
Body mass index
Description
BMI in kg/m^2.
Time Frame
Up to 1 year (the first year)
Title
Rest metabolic rate
Description
Rest metabolic rate in percentage.
Time Frame
Up to 1 year (the first year)
Title
Impedance
Description
Impedance in ohm.
Time Frame
Up to 1 year (the first year)
Title
Resistance
Description
Resistance in ohm.
Time Frame
Up to 1 year (the first year)
Title
Electroencephalography(EEG)
Description
Electroencephalography was assessed during sleep.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Electrooculography(EOG)
Description
Electrooculography was assessed during sleep.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Electromyography(EMG)
Description
Electromyography was assessed during sleep.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Electrocardiography(ECG)
Description
Electrocardiography was assessed during sleep.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Pittsburgh sleep quality index
Time Frame
Up to 1 year (the first year)
Title
Dual energy X-ray absorptiometry
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Triglyceride
Description
Triglyceride in mg/dL.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Total cholesterol
Description
Total cholesterol in mg/dL.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Insulin
Description
Insulin in uIU/mL.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Fasting glucose
Description
Fasting glucose in mg/dL.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Glycated hemoglobin(HbA1C)
Description
HbA1C in percentage.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
High-density lipoprotein
Description
High-density lipoprotein in mg/dL.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Low-density lipoprotein
Description
Low-density lipoprotein in mg/dL.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
C-reactive protein
Description
C-reactive protein in mg/dL.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Heart rate variability
Description
It is measured by the variation in the beat-to-beat interval. Methods used to detect beats is electrocardiography.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Maximum oxygen consumption
Description
Use treadmill exercise testing.
Time Frame
Pretest and after 24 weeks intervention (the second year)
Title
Three factor eating questionnaire
Time Frame
Up to 1 year (the first year)
Title
Taiwan Geriatric Depression Scale
Time Frame
Up to 1 year (the first year)
Title
Groningen Activity Restriction Scale
Time Frame
Up to 1 year (the first year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Community dwelling sedentary men and women who were 65 years or older Exclusion Criteria: 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 History of cognitive or other neurological disorders 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 Unstable or serious medical conditions or cardiopulmonary disease that contraindicate exercise BMI > 35 kg/m2 Individual with a life expectancy of no more than 1 years or final stage of cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng-Yueh Chien, doctor
Organizational Affiliation
National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32394890
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.
Results Reference
derived

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

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