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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02256020 |
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Date of registration:
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24/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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February 2014 |
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Target sample size:
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170 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02256020 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Li-Wei Lin, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Nursing, Hung Kuang University |
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Name:
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Kuender D. Yang, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chang Bing Show Chwan Memorial Hospital |
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Name:
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Kuender D. Yang, PhD |
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Address:
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Telephone:
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886-975617006 |
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Email:
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Affiliation:
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Name:
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Kuender D. Yang, PhD |
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Address:
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Telephone:
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886-975617006 |
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Email:
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yangkd.yeh@hotmail.com |
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Affiliation:
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Name:
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Shu-Hui Yeh, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology |
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Name:
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Yu-Guan Zhuang, M.S.N |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yin Huo Health Association |
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Key inclusion & exclusion criteria
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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
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wheel-chair Dependent Elders
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Intervention(s)
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Other: Wheel-chair music aerobic exercise (WC-MAE)
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Other: Original lifestyle
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Primary Outcome(s)
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Phenotype improvement
[Time Frame: Change from baseline in phenotype at 6 months]
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Secondary Outcome(s)
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Changes of neuro-related hormones
[Time Frame: Changes from baseline in neuro-related hormones at 6 months]
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Immune function improvement
[Time Frame: Changes from baseline in immune function at 6 months]
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Changes of circadian gene expression
[Time Frame: Changes from baseline in circadian gene expression at 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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