<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/NCT03005990</url>
  </required_header>
  <id_info>
    <org_study_id>201512210RIND</org_study_id>
    <nct_id>NCT03005990</nct_id>
  </id_info>
  <brief_title>The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up</brief_title>
  <official_title>The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up: Body Composition and Energy Metabolism</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>
      This study will explore the long-term effects of exercise training on body composition,&#xD;
      cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with sleep&#xD;
      disturbances&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will be conducted in three years:&#xD;
&#xD;
      In the first year,investigators will explore the correlation of sleep parameters, dietary&#xD;
      behavior and body composition in community-dwelling elders. Two hundred elders will be&#xD;
      recruited to receive the actigraph accelerometer recording, sleep quality questionnaire,&#xD;
      bio-electrical impedance analysis, heart rate variability analysis, cognitive and depression&#xD;
      evaluation.&#xD;
&#xD;
      Secondly, the study will evaluate the efficacy and possible mechanisms of a 24-week exercise&#xD;
      training for sleep disturbances patients. Sixty patients with sleep disturbances elders will&#xD;
      be randomized to exercise group or control group. Participants in the exercise group will&#xD;
      receive aerobic and resistance exercise 3 times per week for 24 weeks. The controls will&#xD;
      receive sleep hygiene education and consultation. All measurements will be performed as&#xD;
      described before.&#xD;
&#xD;
      Finally, all the 260 elders participating in this study will receive 12-month follow-up&#xD;
      assessments to explore the longitudinal impact of sleep disturbances on cardiorespiratory&#xD;
      function, body composition and metabolic function, and long-term effect of exercise training&#xD;
      on sleep disturbances patients. Investigators expect elders with poor sleep quality have&#xD;
      lower level of health-related fitness and metabolic function; exercise training is effective&#xD;
      to improve sleep quality, metabolic function and general health in the elders with sleep&#xD;
      disturbances, and the effect can be sustained for a long period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body fat percentage</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
    <description>Body fat percentage in percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body fat mass</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
    <description>Body fat mass in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat free mass</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
    <description>Body fat free mass in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
    <description>BMI in kg/m^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rest metabolic rate</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
    <description>Rest metabolic rate in percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impedance</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
    <description>Impedance in ohm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistance</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
    <description>Resistance in ohm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electroencephalography(EEG)</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Electroencephalography was assessed during sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrooculography(EOG)</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Electrooculography was assessed during sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electromyography(EMG)</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Electromyography was assessed during sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiography(ECG)</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Electrocardiography was assessed during sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh sleep quality index</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual energy X-ray absorptiometry</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Triglyceride in mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Total cholesterol in mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Insulin in uIU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Fasting glucose in mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycated hemoglobin(HbA1C)</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>HbA1C in percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High-density lipoprotein</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>High-density lipoprotein in mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low-density lipoprotein</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Low-density lipoprotein in mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>C-reactive protein in mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>It is measured by the variation in the beat-to-beat interval. Methods used to detect beats is electrocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum oxygen consumption</measure>
    <time_frame>Pretest and after 24 weeks intervention (the second year)</time_frame>
    <description>Use treadmill exercise testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Three factor eating questionnaire</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taiwan Geriatric Depression Scale</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groningen Activity Restriction Scale</measure>
    <time_frame>Up to 1 year (the first year)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Exercise Addiction</condition>
  <condition>Sleep Disorder</condition>
  <arm_group>
    <arm_group_label>Exercise training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group only provide standard outpatient care program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training group</intervention_name>
    <description>The conditioning period (24 weeks) of the exercise intervention was under the supervision of an exercise physiologist. The conditioning protocol included aerobic exercise sessions 3 times per week with 70-85% of maximal heart rate(max HR) for 30 mins and resistance sessions 3 times per week with an intensity of 80% of one-repetition maximum(1RM), 3 sets of 8 repetitions maximum. Each participant will measured the borg rating of perceived exertion scale and heart rate monitor during exercise. Exercise sessions were conducted in the afternoon (3-5 PM).</description>
    <arm_group_label>Exercise training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Community dwelling sedentary men and women who were 65 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of Diagnostic and Statistical Manual Diploma in Social Medicine, 4th. Edition&#xD;
             (DSM-IV) criteria for any major psychiatric disorder, including mania or alcohol or&#xD;
             substance abuse&#xD;
&#xD;
          2. History of cognitive or other neurological disorders&#xD;
&#xD;
          3. Other sleep disorders by history or documented on screening polysomnography (apnea&#xD;
             index &gt;10, periodic leg movement arousal index &gt;15, or rapid eye movement (REM)&#xD;
             behavior disorder&#xD;
&#xD;
          4. Unstable or serious medical conditions or cardiopulmonary disease that contraindicate&#xD;
             exercise&#xD;
&#xD;
          5. BMI &gt; 35 kg/m2&#xD;
&#xD;
          6. Individual with a life expectancy of no more than 1 years or final stage of cancer&#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, doctor</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep disturbance</keyword>
  <keyword>Body composition</keyword>
  <keyword>Energy metabolism</keyword>
  <keyword>Exercise training</keyword>
  <keyword>Community-dwelling elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03005990
org study id: 201512210RIND
nct id: NCT03005990
lead sponsor: 
has dmc: Yes
This study will explore the long-term effects of exercise training on body composition,
      cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with sleep
      disturbances
This project will be conducted in three years:

      In the first year,investigators will explore the correlation of sleep parameters, dietary
      behavior and body composition in community-dwelling elders. Two hundred elders will be
      recruited to receive the actigraph accelerometer recording, sleep quality questionnaire,
      bio-electrical impedance analysis, heart rate variability analysis, cognitive and depression
      evaluation.

      Secondly, the study will evaluate the efficacy and possible mechanisms of a 24-week exercise
      training for sleep disturbances patients. Sixty patients with sleep disturbances 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 24 weeks. The controls will
      receive sleep hygiene education and consultation. All measurements will be performed as
      described before.

      Finally, all the 260 elders participating in this study will receive 12-month follow-up
      assessments to explore the longitudinal impact of sleep disturbances on cardiorespiratory
      function, body composition and metabolic function, and long-term effect of exercise training
      on sleep disturbances patients. Investigators 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 sleep
      disturbances, and the effect can be sustained for a long period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Body fat percentage
time frame: Up to 1 year (the first year)
description: Body fat percentage in percentage.
measure: Body fat mass
time frame: Up to 1 year (the first year)
description: Body fat mass in kilograms.
measure: Body fat free mass
time frame: Up to 1 year (the first year)
description: Body fat free mass in kilograms.
measure: Body mass index
time frame: Up to 1 year (the first year)
description: BMI in kg/m^2.
measure: Rest metabolic rate
time frame: Up to 1 year (the first year)
description: Rest metabolic rate in percentage.
measure: Impedance
time frame: Up to 1 year (the first year)
description: Impedance in ohm.
measure: Resistance
time frame: Up to 1 year (the first year)
description: Resistance in ohm.
measure: Electroencephalography(EEG)
time frame: Pretest and after 24 weeks intervention (the second year)
description: Electroencephalography was assessed during sleep.
measure: Electrooculography(EOG)
time frame: Pretest and after 24 weeks intervention (the second year)
description: Electrooculography was assessed during sleep.
measure: Electromyography(EMG)
time frame: Pretest and after 24 weeks intervention (the second year)
description: Electromyography was assessed during sleep.
measure: Electrocardiography(ECG)
time frame: Pretest and after 24 weeks intervention (the second year)
description: Electrocardiography was assessed during sleep.
measure: Pittsburgh sleep quality index
time frame: Up to 1 year (the first year)
measure: Dual energy X-ray absorptiometry
time frame: Pretest and after 24 weeks intervention (the second year)
measure: Triglyceride
time frame: Pretest and after 24 weeks intervention (the second year)
description: Triglyceride in mg/dL.
measure: Total cholesterol
time frame: Pretest and after 24 weeks intervention (the second year)
description: Total cholesterol in mg/dL.
measure: Insulin
time frame: Pretest and after 24 weeks intervention (the second year)
description: Insulin in uIU/mL.
measure: Fasting glucose
time frame: Pretest and after 24 weeks intervention (the second year)
description: Fasting glucose in mg/dL.
measure: Glycated hemoglobin(HbA1C)
time frame: Pretest and after 24 weeks intervention (the second year)
description: HbA1C in percentage.
measure: High-density lipoprotein
time frame: Pretest and after 24 weeks intervention (the second year)
description: High-density lipoprotein in mg/dL.
measure: Low-density lipoprotein
time frame: Pretest and after 24 weeks intervention (the second year)
description: Low-density lipoprotein in mg/dL.
measure: C-reactive protein
time frame: Pretest and after 24 weeks intervention (the second year)
description: C-reactive protein in mg/dL.
measure: Heart rate variability
time frame: Pretest and after 24 weeks intervention (the second year)
description: It is measured by the variation in the beat-to-beat interval. Methods used to detect beats is electrocardiography.
measure: Maximum oxygen consumption
time frame: Pretest and after 24 weeks intervention (the second year)
description: Use treadmill exercise testing.
measure: Three factor eating questionnaire
time frame: Up to 1 year (the first year)
measure: Taiwan Geriatric Depression Scale
time frame: Up to 1 year (the first year)
measure: Groningen Activity Restriction Scale
time frame: Up to 1 year (the first year)
arm group label: Exercise training group
arm group type: Experimental
description: Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.
arm group label: Control group
arm group type: No Intervention
description: Control group only provide standard outpatient care program.
intervention type: Other
intervention name: Exercise training group
description: The conditioning period (24 weeks) of the exercise intervention was under the supervision of an exercise physiologist. The conditioning protocol included aerobic exercise sessions 3 times per week with 70-85% of maximal heart rate(max HR) for 30 mins and resistance sessions 3 times per week with an intensity of 80% of one-repetition maximum(1RM), 3 sets of 8 repetitions maximum. Each participant will measured the borg rating of perceived exertion scale and heart rate monitor during exercise. Exercise sessions were conducted in the afternoon (3-5 PM).
arm group label: Exercise training group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Meng-Yueh Chien, doctor
role: Study Chair
affiliation: National Taiwan University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Dyssomnias
sharing ipd: Undecided