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

NCT02256020 | Unknown

• 1 other identifier: 1030104
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Wheel-chair Dependent Elders

Keywords

Wheel-chair dependent, music aerobic exercise, depression, insomnia

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline in phenotype at 6 months

Secondary Outcomes (3)

• Changes of neuro-related hormones

  Changes from baseline in neuro-related hormones at 6 months

• Changes of circadian gene expression

  Changes from baseline in circadian gene expression at 6 months

• Immune function improvement

  Changes from baseline in immune function at 6 months

Study Arms (2)

Original lifestyle

OTHER

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

Other: Original lifestyle

Wheel-chair music aerobic exercise

EXPERIMENTAL

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)

Interventions

Original lifestyle OTHER

Control group with 3 times of watching 50-minute television a week for 6 months.

Original lifestyle

Wheel-chair music aerobic exercise (WC-MAE) OTHER

Wheel-chair music aerobic exercise with 3 times of 50-minute session a week for 6 months.

Wheel-chair music aerobic exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Bing Show Chwan Memorial Hospital: lead

Study Sites (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, Taiwan

RECRUITING

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kuender D. Yang, PhD

  Chang Bing Show Chwan Memorial Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuender D. Yang, PhD

CONTACT

886-975617006

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Professor

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 3, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

TW (1)