Clinical trial NCT02256020: Improvement and Mechanism of Wheel-chair Music Aerobic Exercise on Depression and Insomnia Among the Elderly in Long-term Care Facilities
Official title: Improvement and Mechanism of Wheel-chair Music Aerobic Exercise on Depression and Insomnia Among the Elderly in Long-term Care Facilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wheel-chair Dependent Elders
Keywords: Wheel-chair dependent, music aerobic exercise, depression, insomnia
Lead sponsor: Chang Bing Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 170
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Phenotype improvement
timeFrame: Change from baseline in phenotype at 6 months
Secondary outcomes:
measure: Changes of neuro-related hormones
timeFrame: Changes from baseline in neuro-related hormones at 6 months
measure: Changes of circadian gene expression
timeFrame: Changes from baseline in circadian gene expression at 6 months
measure: Immune function improvement
timeFrame: Changes from baseline in immune function at 6 months
Other outcomes:
Locations:
city: Changhua County
country: Taiwan
facility: Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Study officials:
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Kuender D. Yang, PhD
role: STUDY_CHAIR
affiliation: Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
name: Shu-Hui Yeh, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nursing, Hung Kuang University
name: Li-Wei Lin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yin Huo Health Association
name: Yu-Guan Zhuang, M.S.N
role: PRINCIPAL_INVESTIGATOR
References: