Improvement and Mechanism of Wheel-chair Music Aerobic Exercise on Depression and Insomnia Among the Elderly in Long-term Care Facilities
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|ClinicalTrials.gov Identifier: NCT02256020|
Recruitment Status : Unknown
Verified October 2014 by Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital.
Recruitment status was: Recruiting
First Posted : October 3, 2014
Last Update Posted : October 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Wheel-chair Dependent Elders||Other: Original lifestyle Other: Wheel-chair music aerobic exercise (WC-MAE)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Improvement and Mechanism of Wheel-chair Music Aerobic Exercise on Depression and Insomnia Among the Elderly in Long-term Care Facilities|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||February 2015|
Original lifestyle, watching TV 50 minutes, three times a week for 6 months.
Other: Original lifestyle
Control group with 3 times of watching 50-minute television a week for 6 months.
Experimental: 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.
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.
- Phenotype improvement [ Time Frame: Change from baseline in phenotype at 6 months ]The participants will receive depression and insomnia measured before exercise and at 3 months and 6 months after starting WC-MAE to detect the changes of outcome indicators. The structured questionnaire interview will be done in each participant's long term care facilities by clinical study nurses. Five structured questionnaires including Short Portable Mental Status Questionnaire (SPMSQ) (Pfeiffer, 1975), demographic questionnaire, Beck Depression Inventory II (Bect, Steer & Brown, 1996), Pittsburgh Sleep Quality Index, (PSQI) (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989) and Outcome Expectation for Exercise (OEE) will be used for data collection.
- Changes of neuro-related hormones [ Time Frame: Changes from baseline in neuro-related hormones at 6 months ]Peripheral blood will be collected before exercise and at 3 months and 6 months after starting WC-MAE to detect the changes of neuro-related hormones including DHEA-S, estradiol, DHT, progesterone, pregnenolone, total and free testosterone, epinephrine, norepinephrine, BDNF and GH.
- Changes of circadian gene expression [ Time Frame: Changes from baseline in circadian gene expression at 6 months ]Peripheral blood will be collected before exercise and at 3 months and 6 months after starting WC-MAE. After separation of blood leukocytes, the total RNA will be extracted to detect the changes of circadian gene expression including PER1, DBP, NR1D1, BMAL.
- Immune function improvement [ Time Frame: Changes from baseline in immune function at 6 months ]Peripheral blood will be collected before exercise and at 3 months and 6 months after starting WC-MAE to detect the changes of lymphocyte subpopulations (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt), its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256020
|Contact: Kuender D. Yang, PhD||886-975617006|
|Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital||Recruiting|
|Changhua County, Taiwan|
|Contact: Kuender D. Yang, PhD 886-975617006 email@example.com|
|Study Chair:||Kuender D. Yang, PhD||Chang Bing Show Chwan Memorial Hospital|
|Principal Investigator:||Shu-Hui Yeh, PhD.||Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology|
|Principal Investigator:||Li-Wei Lin, PhD||Department of Nursing, Hung Kuang University|
|Principal Investigator:||Yu-Guan Zhuang, M.S.N||Yin Huo Health Association|