<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/NCT01689818</url>
  </required_header>
  <id_info>
    <org_study_id>201012130RB</org_study_id>
    <nct_id>NCT01689818</nct_id>
  </id_info>
  <brief_title>Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia</brief_title>
  <official_title>Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Poor sleep quality has been recognized as a major public health concern in the world. The&#xD;
      prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated&#xD;
      that up to 50% of elderly complain about their sleep. Insomnia is associated with anxiety,&#xD;
      falls, or cognitive impairment in the elderly, which may compromise their daily activities&#xD;
      function and quality of life.&#xD;
&#xD;
      Recently, researches have demonstrated the associations between insomnia and endocrine system&#xD;
      dysfunction, metabolic disorders, and cardiovascular events and death. Therefore, it is an&#xD;
      important issue to improve sleep quality of the elders. The side-effects of pharmacological&#xD;
      treatments and high-cost of cognitive behavior therapy limit their accessibility and&#xD;
      effectiveness, and exercise training has been expected to provide an alternative intervention&#xD;
      for insomnia. However, the long-term impact of insomnia on health-related fitness and&#xD;
      metabolic function, and the effect of exercise training remain inconclusive. Therefore, the&#xD;
      study hypothesis is that exercise training affect functional performance and quality of life&#xD;
      in community-dwelling elderly with insomnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will be conducted in three years:&#xD;
&#xD;
      In the first year, we will compare the cardiorespiratory function, body composition, physical&#xD;
      activity, and metabolic biochemistry parameters in community-dwelling elders with good and&#xD;
      poor sleep quality. One hundred and twenty elders will be recruited to receive the actigraph&#xD;
      accelermometer recording, sleep quality questionnaire, exercise test, bioelectrical impedance&#xD;
      analysis, heart rate variability analysis, cognitive and depression evaluation, and&#xD;
      biochemistry analysis.&#xD;
&#xD;
      Secondly, the study will evaluate the efficacy and possible mechanisms of a 16-week exercise&#xD;
      training for insomnia. Sixty patients with insomnia elders will be randomized to exercise&#xD;
      group or control group. Participants in the exercise group will receive aerobic and&#xD;
      resistance exercise 3 times per week for 16 weeks. The controls will receive sleep hygiene&#xD;
      education and consultation. All measurements will be performed as described before.&#xD;
&#xD;
      Finally, all the 120 elders participating in this study will receive 12-month follow-up&#xD;
      assessments to explore the longitudinal impact of insomnia on cardiorespiratory function,&#xD;
      body composition and metabolic function, and long-term effect of exercise training on&#xD;
      insomnia. We expect elders with poor sleep quality have lower level of health-related fitness&#xD;
      and metabolic function; exercise training is effective to improve sleep quality, metabolic&#xD;
      function and general health in the elders with insomnia, and the effect can be sustained for&#xD;
      a long period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">July 2014</completion_date>
  <primary_completion_date type="Anticipated">July 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>functional performance</measure>
    <time_frame>16 weeks</time_frame>
    <description>physical fitness and physical disability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>depression</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>cognitive function</measure>
    <time_frame>16 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>exercise training program which included aerobic exercise for 3 times per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>lifestyle counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise training</intervention_name>
    <description>exercise training program which included aerobic exercise for 3 times per week.</description>
    <arm_group_label>exercise training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  above 65 y/o elderly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychiatric diagnosis (DSM-IV) of serious mental illness, including severe depression&#xD;
             symptoms, mania, Alcohol or drug abuse&#xD;
&#xD;
          -  with other sleep disorders such as sleep apnea, periodic limb twitching, or fast&#xD;
             moving eye movement behavior disorder&#xD;
&#xD;
          -  cognitive and other neurological diseases history who can not communicate&#xD;
&#xD;
          -  Unstable serious illness or sports contraindicated cardiopulmonary disease such as&#xD;
             diabetes, hypertension, and other cardiovascular disease, neurological injury patients&#xD;
&#xD;
          -  body mass index greater than 35 kg/ M 2 or more&#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>Meng-Yueh Chien, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Meng-Yueh Chien, Ph.D</last_name>
    <phone>886-2-3366-8141</phone>
    <email>mychien@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meng-Yueh Chien</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 20, 2012</last_update_submitted>
  <last_update_submitted_qc>September 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>insomnia, elderly, exercise training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</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/NCT01689818
org study id: 201012130RB
nct id: NCT01689818
lead sponsor: 
has dmc: Yes
Poor sleep quality has been recognized as a major public health concern in the world. The
      prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated
      that up to 50% of elderly complain about their sleep. Insomnia is associated with anxiety,
      falls, or cognitive impairment in the elderly, which may compromise their daily activities
      function and quality of life.

      Recently, researches have demonstrated the associations between insomnia and endocrine system
      dysfunction, metabolic disorders, and cardiovascular events and death. Therefore, it is an
      important issue to improve sleep quality of the elders. The side-effects of pharmacological
      treatments and high-cost of cognitive behavior therapy limit their accessibility and
      effectiveness, and exercise training has been expected to provide an alternative intervention
      for insomnia. However, the long-term impact of insomnia on health-related fitness and
      metabolic function, and the effect of exercise training remain inconclusive. Therefore, the
      study hypothesis is that exercise training affect functional performance and quality of life
      in community-dwelling elderly with insomnia.
This project will be conducted in three years:

      In the first year, we will compare the cardiorespiratory function, body composition, physical
      activity, and metabolic biochemistry parameters in community-dwelling elders with good and
      poor sleep quality. One hundred and twenty elders will be recruited to receive the actigraph
      accelermometer recording, sleep quality questionnaire, exercise test, bioelectrical impedance
      analysis, heart rate variability analysis, cognitive and depression evaluation, and
      biochemistry analysis.

      Secondly, the study will evaluate the efficacy and possible mechanisms of a 16-week exercise
      training for insomnia. Sixty patients with insomnia elders will be randomized to exercise
      group or control group. Participants in the exercise group will receive aerobic and
      resistance exercise 3 times per week for 16 weeks. The controls will receive sleep hygiene
      education and consultation. All measurements will be performed as described before.

      Finally, all the 120 elders participating in this study will receive 12-month follow-up
      assessments to explore the longitudinal impact of insomnia on cardiorespiratory function,
      body composition and metabolic function, and long-term effect of exercise training on
      insomnia. We expect elders with poor sleep quality have lower level of health-related fitness
      and metabolic function; exercise training is effective to improve sleep quality, metabolic
      function and general health in the elders with insomnia, and the effect can be sustained for
      a long period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: functional performance
time frame: 16 weeks
description: physical fitness and physical disability
measure: depression
time frame: 16 weeks
measure: cognitive function
time frame: 16 weeks
arm group label: exercise training
arm group type: Experimental
description: exercise training program which included aerobic exercise for 3 times per week.
arm group label: control
arm group type: No Intervention
description: lifestyle counseling
intervention type: Other
intervention name: exercise training
description: exercise training program which included aerobic exercise for 3 times per week.
arm group label: exercise training
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Meng-Yueh Chien, PhD
role: Principal Investigator
affiliation: National Taiwan University
last name: Meng-Yueh Chien, Ph.D
phone: 886-2-3366-8141
email: mychien@ntu.edu.tw
facility: 
status: Recruiting
country: Taiwan
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders