Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia
Primary Purpose
Insomnia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring insomnia, elderly, exercise training
Eligibility Criteria
Inclusion Criteria:
- above 65 y/o elderly
Exclusion Criteria:
- psychiatric diagnosis (DSM-IV) of serious mental illness, including severe depression symptoms, mania, Alcohol or drug abuse
- with other sleep disorders such as sleep apnea, periodic limb twitching, or fast moving eye movement behavior disorder
- cognitive and other neurological diseases history who can not communicate
- Unstable serious illness or sports contraindicated cardiopulmonary disease such as diabetes, hypertension, and other cardiovascular disease, neurological injury patients
- body mass index greater than 35 kg/ M 2 or more
Sites / Locations
- Meng-Yueh ChienRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
exercise training
control
Arm Description
exercise training program which included aerobic exercise for 3 times per week.
lifestyle counseling
Outcomes
Primary Outcome Measures
functional performance
physical fitness and physical disability
Secondary Outcome Measures
depression
Full Information
NCT ID
NCT01689818
First Posted
August 28, 2012
Last Updated
September 20, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01689818
Brief Title
Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia
Official Title
Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (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
Poor sleep quality has been recognized as a major public health concern in the world. The prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated that up to 50% of elderly complain about their sleep. Insomnia is associated with anxiety, falls, or cognitive impairment in the elderly, which may compromise their daily activities function and quality of life.
Recently, researches have demonstrated the associations between insomnia and endocrine system dysfunction, metabolic disorders, and cardiovascular events and death. Therefore, it is an important issue to improve sleep quality of the elders. The side-effects of pharmacological treatments and high-cost of cognitive behavior therapy limit their accessibility and effectiveness, and exercise training has been expected to provide an alternative intervention for insomnia. However, the long-term impact of insomnia on health-related fitness and metabolic function, and the effect of exercise training remain inconclusive. Therefore, the study hypothesis is that exercise training affect functional performance and quality of life in community-dwelling elderly with insomnia.
Detailed Description
This project will be conducted in three years:
In the first year, we will compare the cardiorespiratory function, body composition, physical activity, and metabolic biochemistry parameters in community-dwelling elders with good and poor sleep quality. One hundred and twenty elders will be recruited to receive the actigraph accelermometer recording, sleep quality questionnaire, exercise test, bioelectrical impedance analysis, heart rate variability analysis, cognitive and depression evaluation, and biochemistry analysis.
Secondly, the study will evaluate the efficacy and possible mechanisms of a 16-week exercise training for insomnia. Sixty patients with insomnia 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 16 weeks. The controls will receive sleep hygiene education and consultation. All measurements will be performed as described before.
Finally, all the 120 elders participating in this study will receive 12-month follow-up assessments to explore the longitudinal impact of insomnia on cardiorespiratory function, body composition and metabolic function, and long-term effect of exercise training on insomnia. We 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 insomnia, 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
Insomnia
Keywords
insomnia, elderly, exercise training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise training
Arm Type
Experimental
Arm Description
exercise training program which included aerobic exercise for 3 times per week.
Arm Title
control
Arm Type
No Intervention
Arm Description
lifestyle counseling
Intervention Type
Other
Intervention Name(s)
exercise training
Intervention Description
exercise training program which included aerobic exercise for 3 times per week.
Primary Outcome Measure Information:
Title
functional performance
Description
physical fitness and physical disability
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
depression
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
cognitive function
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
above 65 y/o elderly
Exclusion Criteria:
psychiatric diagnosis (DSM-IV) of serious mental illness, including severe depression symptoms, mania, Alcohol or drug abuse
with other sleep disorders such as sleep apnea, periodic limb twitching, or fast moving eye movement behavior disorder
cognitive and other neurological diseases history who can not communicate
Unstable serious illness or sports contraindicated cardiopulmonary disease such as diabetes, hypertension, and other cardiovascular disease, neurological injury patients
body mass index greater than 35 kg/ M 2 or more
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meng-Yueh Chien, Ph.D
Phone
886-2-3366-8141
Email
mychien@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng-Yueh Chien, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meng-Yueh Chien
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
25515275
Citation
Chien MY, Chen HC. Poor sleep quality is independently associated with physical disability in older adults. J Clin Sleep Med. 2015 Mar 15;11(3):225-32. doi: 10.5664/jcsm.4532.
Results Reference
derived
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Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia
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