Improvement and Mechanism of Wheel-chair Music Aerobic Exercise on Depression and Insomnia Among the Elderly in Long-term Care Facilities
NCT ID: NCT02256020
Last Updated: 2014-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
170 participants
INTERVENTIONAL
2014-02-28
2015-02-28
Brief Summary
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Detailed Description
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Tai-chi Chuan exercise requires more endurance of static posture and is not suitable for wheel-chair dependent elders. Our preliminary studies have found that music aerobic exercise (MAE) could enhance certain immune functions of middle-age women (Yeh, Lai, Hsiao, Lin, Chung, \& Yan, J Phys Act Health 2013). We chose to modify the MAE to a customized wheel-chair music aerobic exercise (WC-MAE) for physical disabled elders in long term care facilities. During the past year, we have effectively modified the original MAE to be a novel WC-MAE. We developed a WC-MAE program consisting of three weekly 50 minute sessions. These sessions are classified as moderate exercise with a goal of a maximum heart rate (HRmax) of 65%. During this 2-year project, we will do cluster randomization of 170 participants (85 pairs) from 4 long term care facilities into experimental group (with WC-MAE at 10 minutes warm up, 30 minutes exercise and 10 minutes cool down) and comparison group (watching TV 50 minutes), based on the power of 0.8, effect size of 0.28, one-tailed, alpha value of 0.05 and 10% withdrawal rate. In the first year, we will examine the effects of WC-MAE on wheel-chair dependent elders on self-perceived health, outcome expectation of exercise, and improvement of insomnia and depression scores, in pretest and the posttest at 3 months. During the second year we will study the post-test at 6 months, and investigate the mechanisms of the improvement on insomnia and depression. Blood leukocytes and plasma will be collected at pre-test, 3 and 6 months post-test for investigating changes of circadian gene expression, inflammatory cytokines, and neuro-related hormones in leukocytes and plasma. The circadian rhythm, immunity and hormone pathways will be analyzed and correlated to changes in the outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Original lifestyle
Original lifestyle, watching TV 50 minutes, three times a week for 6 months.
Original lifestyle
Control group with 3 times of watching 50-minute television a week for 6 months.
Wheel-chair music aerobic exercise
Wheel-chair music aerobic exercise with 3 times of 50-minute session (10 minutes warm up, 30 minutes exercise and 10 minutes cool down) a week for 6 months.
Wheel-chair music aerobic exercise (WC-MAE)
Wheel-chair music aerobic exercise with 3 times of 50-minute session a week for 6 months.
Interventions
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Original lifestyle
Control group with 3 times of watching 50-minute television a week for 6 months.
Wheel-chair music aerobic exercise (WC-MAE)
Wheel-chair music aerobic exercise with 3 times of 50-minute session a week for 6 months.
Eligibility Criteria
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Inclusion Criteria
* Resident in one of the selected long-term care facilities and age 65 years or above
* Able to communicate in Mandarin or Taiwanese
Exclusion Criteria
* Major cardiovascular diseases, requires screening before the exercise
* Immune diseases
* Drug-induced depression
65 Years
ALL
Yes
Sponsors
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Chang Bing Show Chwan Memorial Hospital
OTHER
Responsible Party
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Shu-Hui Yeh
RN, PhD, Professor
Principal Investigators
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Kuender D. Yang, PhD
Role: STUDY_CHAIR
Chang Bing Show Chwan Memorial Hospital
Shu-Hui Yeh, PhD.
Role: PRINCIPAL_INVESTIGATOR
Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
Li-Wei Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Nursing, Hung Kuang University
Yu-Guan Zhuang, M.S.N
Role: PRINCIPAL_INVESTIGATOR
Yin Huo Health Association
Locations
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Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Changhua County, , Taiwan
Countries
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Central Contacts
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Kuender D. Yang, PhD
Role: CONTACT
Facility Contacts
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Other Identifiers
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1030104
Identifier Type: -
Identifier Source: org_study_id
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