<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02256020</url>
  </required_header>
  <id_info>
    <org_study_id>1030104</org_study_id>
    <nct_id>NCT02256020</nct_id>
  </id_info>
  <brief_title>Improvement and Mechanism of Wheel-chair Music Aerobic Exercise on Depression and Insomnia Among the Elderly in Long-term Care Facilities</brief_title>
  <official_title>Improvement and Mechanism of Wheel-chair Music Aerobic Exercise on Depression and Insomnia Among the Elderly in Long-term Care Facilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Bing Show Chwan Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Bing Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators anticipate to develop a customized WC-MAE for the improvement of insomnia and&#xD;
      depression in wheel-chair dependent elders, and to identify related mechanisms as biomarkers&#xD;
      for prediction and prevention of insomnia and depression in elders with physical disability&#xD;
      in long term care facilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been shown that two-thirds of elderly residents living in long term care facilities&#xD;
      lack regular exercise. The lack of physical activity may cause decreased physical function,&#xD;
      impaired immunity, insomnia and depression. Insomnia can affect circadian rhythm, control of&#xD;
      emotion and blood pressure. Depression can affect hormone regulation and quality of life.&#xD;
      More importantly, depression has been recognized as one of the world's top three health&#xD;
      problems by the World Health Organization. In Taiwan, our previous study showed that the&#xD;
      prevalence of depression in community elderly was 27.5% (Tsai, Yeh &amp; Tsai, Int J Geriatric&#xD;
      Psychiatr. 2005). We also demonstrated that Tai Chi Chuan exercise improved balance, nerve&#xD;
      conductivity and immunity (Yeh, Chuang, Lin, Hsiao, &amp; Eng, Br J Sports Med. 2006; Hung, Liou,&#xD;
      Wang, &amp; Yeh, J Rehabilit Med. 2009). A recent study that followed 3500 elders (&gt; 64 years of&#xD;
      age) for 8 years in the United Kingdom showed that exercise, no matter at what age it began,&#xD;
      significantly improved physical function (Kaasalainen, Kasila, Villberg, Komulainen, &amp;&#xD;
      Poskiparta, BMC Public Health. 2013). Thus, we hypothesized that those wheel-chair dependent&#xD;
      elders, who exercise less due to physical disability, have poor sleep quality that causes&#xD;
      emotional disturbance and potential depression. A customized wheel-chair exercise for the&#xD;
      elderly of long term care facilities might promote physical activity and improve insomnia and&#xD;
      depression.&#xD;
&#xD;
      Tai-chi Chuan exercise requires more endurance of static posture and is not suitable for&#xD;
      wheel-chair dependent elders. Our preliminary studies have found that music aerobic exercise&#xD;
      (MAE) could enhance certain immune functions of middle-age women (Yeh, Lai, Hsiao, Lin,&#xD;
      Chung, &amp; Yan, J Phys Act Health 2013). We chose to modify the MAE to a customized wheel-chair&#xD;
      music aerobic exercise (WC-MAE) for physical disabled elders in long term care facilities.&#xD;
      During the past year, we have effectively modified the original MAE to be a novel WC-MAE. We&#xD;
      developed a WC-MAE program consisting of three weekly 50 minute sessions. These sessions are&#xD;
      classified as moderate exercise with a goal of a maximum heart rate (HRmax) of 65%. During&#xD;
      this 2-year project, we will do cluster randomization of 170 participants (85 pairs) from 4&#xD;
      long term care facilities into experimental group (with WC-MAE at 10 minutes warm up, 30&#xD;
      minutes exercise and 10 minutes cool down) and comparison group (watching TV 50 minutes),&#xD;
      based on the power of 0.8, effect size of 0.28, one-tailed, alpha value of 0.05 and 10%&#xD;
      withdrawal rate. In the first year, we will examine the effects of WC-MAE on wheel-chair&#xD;
      dependent elders on self-perceived health, outcome expectation of exercise, and improvement&#xD;
      of insomnia and depression scores, in pretest and the posttest at 3 months. During the second&#xD;
      year we will study the post-test at 6 months, and investigate the mechanisms of the&#xD;
      improvement on insomnia and depression. Blood leukocytes and plasma will be collected at&#xD;
      pre-test, 3 and 6 months post-test for investigating changes of circadian gene expression,&#xD;
      inflammatory cytokines, and neuro-related hormones in leukocytes and plasma. The circadian&#xD;
      rhythm, immunity and hormone pathways will be analyzed and correlated to changes in the&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phenotype improvement</measure>
    <time_frame>Change from baseline in phenotype at 6 months</time_frame>
    <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 &amp; Brown, 1996), Pittsburgh Sleep Quality Index, (PSQI) (Buysse, Reynolds, Monk, Berman, &amp; Kupfer, 1989) and Outcome Expectation for Exercise (OEE) will be used for data collection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of neuro-related hormones</measure>
    <time_frame>Changes from baseline in neuro-related hormones at 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of circadian gene expression</measure>
    <time_frame>Changes from baseline in circadian gene expression at 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune function improvement</measure>
    <time_frame>Changes from baseline in immune function at 6 months</time_frame>
    <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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Wheel-chair Dependent Elders</condition>
  <arm_group>
    <arm_group_label>Original lifestyle</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Original lifestyle, watching TV 50 minutes, three times a week for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wheel-chair music aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Original lifestyle</intervention_name>
    <description>Control group with 3 times of watching 50-minute television a week for 6 months.</description>
    <arm_group_label>Original lifestyle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wheel-chair music aerobic exercise (WC-MAE)</intervention_name>
    <description>Wheel-chair music aerobic exercise with 3 times of 50-minute session a week for 6 months.</description>
    <arm_group_label>Wheel-chair music aerobic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Live in central and southern Taiwan&#xD;
&#xD;
          -  Resident in one of the selected long-term care facilities and age 65 years or above&#xD;
&#xD;
          -  Able to communicate in Mandarin or Taiwanese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive deficit (screen by using short portable mental status questionnaire,&#xD;
             SPMSQ) (Pfeiffer, 1975)&#xD;
&#xD;
          -  Major cardiovascular diseases, requires screening before the exercise&#xD;
&#xD;
          -  Immune diseases&#xD;
&#xD;
          -  Drug-induced depression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuender D. Yang, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shu-Hui Yeh, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital &amp; Central Taiwan University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Li-Wei Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nursing, Hung Kuang University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yu-Guan Zhuang, M.S.N</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yin Huo Health Association</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kuender D. Yang, PhD</last_name>
    <phone>886-975617006</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua County</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kuender D. Yang, PhD</last_name>
      <phone>886-975617006</phone>
      <email>yangkd.yeh@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Bing Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Shu-Hui Yeh</investigator_full_name>
    <investigator_title>RN, PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Wheel-chair dependent, music aerobic exercise, depression, insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02256020
org study id: 1030104
nct id: NCT02256020
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Phenotype improvement
time frame: Change from baseline in phenotype at 6 months
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.
measure: Changes of neuro-related hormones
time frame: Changes from baseline in neuro-related hormones at 6 months
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.
measure: Changes of circadian gene expression
time frame: Changes from baseline in circadian gene expression at 6 months
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.
measure: Immune function improvement
time frame: Changes from baseline in immune function at 6 months
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).
arm group label: Original lifestyle
arm group type: Other
description: Original lifestyle, watching TV 50 minutes, three times a week for 6 months.
arm group label: Wheel-chair music aerobic exercise
arm group type: Experimental
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: Original lifestyle
description: Control group with 3 times of watching 50-minute television a week for 6 months.
arm group label: Original lifestyle
intervention type: Other
intervention name: Wheel-chair music aerobic exercise (WC-MAE)
description: Wheel-chair music aerobic exercise with 3 times of 50-minute session a week for 6 months.
arm group label: Wheel-chair music aerobic exercise
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kuender D. Yang, PhD
role: Study Chair
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Shu-Hui Yeh, PhD.
role: Principal Investigator
affiliation: Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
last name: Li-Wei Lin, PhD
role: Principal Investigator
affiliation: Department of Nursing, Hung Kuang University
last name: Yu-Guan Zhuang, M.S.N
role: Principal Investigator
affiliation: Yin Huo Health Association
last name: Kuender D. Yang, PhD
phone: 886-975617006
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Bing Show Chwan Memorial Hospital
investigator full name: Shu-Hui Yeh
investigator title: RN, PhD, Professor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression