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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

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Investigators anticipate to develop a customized WC-MAE for the improvement of insomnia and depression in wheel-chair dependent elders, and to identify related mechanisms as biomarkers for prediction and prevention of insomnia and depression in elders with physical disability in long term care facilities.

Detailed Description

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It has been shown that two-thirds of elderly residents living in long term care facilities lack regular exercise. The lack of physical activity may cause decreased physical function, impaired immunity, insomnia and depression. Insomnia can affect circadian rhythm, control of emotion and blood pressure. Depression can affect hormone regulation and quality of life. More importantly, depression has been recognized as one of the world's top three health problems by the World Health Organization. In Taiwan, our previous study showed that the prevalence of depression in community elderly was 27.5% (Tsai, Yeh \& Tsai, Int J Geriatric Psychiatr. 2005). We also demonstrated that Tai Chi Chuan exercise improved balance, nerve conductivity and immunity (Yeh, Chuang, Lin, Hsiao, \& Eng, Br J Sports Med. 2006; Hung, Liou, Wang, \& Yeh, J Rehabilit Med. 2009). A recent study that followed 3500 elders (\> 64 years of age) for 8 years in the United Kingdom showed that exercise, no matter at what age it began, significantly improved physical function (Kaasalainen, Kasila, Villberg, Komulainen, \& Poskiparta, BMC Public Health. 2013). Thus, we hypothesized that those wheel-chair dependent elders, who exercise less due to physical disability, have poor sleep quality that causes emotional disturbance and potential depression. A customized wheel-chair exercise for the elderly of long term care facilities might promote physical activity and improve insomnia and depression.

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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Wheel-chair Dependent Elders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Original lifestyle

Original lifestyle, watching TV 50 minutes, three times a week for 6 months.

Group Type OTHER

Original lifestyle

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Wheel-chair music aerobic exercise (WC-MAE)

Intervention Type OTHER

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.

Intervention Type OTHER

Wheel-chair music aerobic exercise (WC-MAE)

Wheel-chair music aerobic exercise with 3 times of 50-minute session a week for 6 months.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Live in central and southern Taiwan
* 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

* Severe cognitive deficit (screen by using short portable mental status questionnaire, SPMSQ) (Pfeiffer, 1975)
* Major cardiovascular diseases, requires screening before the exercise
* Immune diseases
* Drug-induced depression
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Bing Show Chwan Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shu-Hui Yeh

RN, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuender D. Yang, PhD

Role: CONTACT

886-975617006

Facility Contacts

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Kuender D. Yang, PhD

Role: primary

886-975617006

Other Identifiers

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1030104

Identifier Type: -

Identifier Source: org_study_id

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