Improvement and Mechanism of Wheel-chair Music Aerobic Exercise on Depression and Insomnia Among the Elderly in Long-term Care Facilities

Sponsor
Chang Bing Show Chwan Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02256020
Collaborator
(none)
170
1
2
12
14.2

Study Details

Study Description

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
  • Other: Original lifestyle
  • Other: Wheel-chair music aerobic exercise (WC-MAE)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2014
Anticipated Primary Completion Date :
Feb 1, 2015
Anticipated Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Phenotype improvement [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital Changhua County Taiwan

Sponsors and Collaborators

  • Chang Bing Show Chwan Memorial Hospital

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shu-Hui Yeh, RN, PhD, Professor, Chang Bing Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02256020
Other Study ID Numbers:
  • 1030104
First Posted:
Oct 3, 2014
Last Update Posted:
Oct 3, 2014
Last Verified:
Oct 1, 2014
Keywords provided by Shu-Hui Yeh, RN, PhD, Professor, Chang Bing Show Chwan Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2014