search
Back to results

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

Primary Purpose

Wheel-chair Dependent Elders

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Original lifestyle
Wheel-chair music aerobic exercise (WC-MAE)
Sponsored by
Chang Bing Show Chwan Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wheel-chair Dependent Elders focused on measuring Wheel-chair dependent, music aerobic exercise, depression, insomnia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Core Laboratory; Chang Bing Show Chwan Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Original lifestyle

Wheel-chair music aerobic exercise

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Phenotype improvement
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

Changes of neuro-related hormones
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
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
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).

Full Information

First Posted
September 24, 2014
Last Updated
October 1, 2014
Sponsor
Chang Bing Show Chwan Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02256020
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Bing Show Chwan Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheel-chair Dependent Elders
Keywords
Wheel-chair dependent, music aerobic exercise, depression, insomnia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Original lifestyle
Arm Type
Other
Arm Description
Original lifestyle, watching TV 50 minutes, three times a week for 6 months.
Arm Title
Wheel-chair music aerobic exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Original lifestyle
Intervention Description
Control group with 3 times of watching 50-minute television a week for 6 months.
Intervention Type
Other
Intervention Name(s)
Wheel-chair music aerobic exercise (WC-MAE)
Intervention Description
Wheel-chair music aerobic exercise with 3 times of 50-minute session a week for 6 months.
Primary Outcome Measure Information:
Title
Phenotype improvement
Description
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.
Time Frame
Change from baseline in phenotype at 6 months
Secondary Outcome Measure Information:
Title
Changes of neuro-related hormones
Description
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.
Time Frame
Changes from baseline in neuro-related hormones at 6 months
Title
Changes of circadian gene expression
Description
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.
Time Frame
Changes from baseline in circadian gene expression at 6 months
Title
Immune function improvement
Description
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).
Time Frame
Changes from baseline in immune function at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuender D. Yang, PhD
Phone
886-975617006
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuender D. Yang, PhD
Organizational Affiliation
Chang Bing Show Chwan Memorial Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shu-Hui Yeh, PhD.
Organizational Affiliation
Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li-Wei Lin, PhD
Organizational Affiliation
Department of Nursing, Hung Kuang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu-Guan Zhuang, M.S.N
Organizational Affiliation
Yin Huo Health Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
City
Changhua County
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuender D. Yang, PhD
Phone
886-975617006
Email
yangkd.yeh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs