Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedSeptember 21, 2012
September 1, 2012
2.9 years
August 28, 2012
September 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
functional performance
physical fitness and physical disability
16 weeks
Secondary Outcomes (1)
depression
16 weeks
Other Outcomes (1)
cognitive function
16 weeks
Study Arms (2)
exercise training
EXPERIMENTALexercise training program which included aerobic exercise for 3 times per week.
control
NO INTERVENTIONlifestyle counseling
Interventions
exercise training program which included aerobic exercise for 3 times per week.
Eligibility Criteria
You may qualify if:
- above 65 y/o elderly
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meng-Yueh Chien
Taipei, Taiwan
Related Publications (1)
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.
PMID: 25515275DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meng-Yueh Chien, PhD
National Taiwan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2012
First Posted
September 21, 2012
Study Start
August 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
September 21, 2012
Record last verified: 2012-09