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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
Sponsor:
Information provided by (Responsible Party):
Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Wheel-chair Dependent Elders Other: Original lifestyle Other: Wheel-chair music aerobic exercise (WC-MAE) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Original lifestyle
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Kuender D. Yang, PhD 886-975617006

Locations
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Taiwan
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital Recruiting
Changhua County, Taiwan
Contact: Kuender D. Yang, PhD    886-975617006    yangkd.yeh@hotmail.com   
Sponsors and Collaborators
Chang Bing Show Chwan Memorial Hospital
Investigators
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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

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Responsible Party: Shu-Hui Yeh, RN, PhD, Professor, Chang Bing Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT02256020     History of Changes
Other Study ID Numbers: 1030104
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014
Keywords provided by Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital:
Wheel-chair dependent, music aerobic exercise, depression, insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Depression
Behavioral Symptoms
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases