<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/NCT02260843</url>
  </required_header>
  <id_info>
    <org_study_id>TaiChi and Insonmia</org_study_id>
    <nct_id>NCT02260843</nct_id>
  </id_info>
  <brief_title>Efficacy of Tai Chi Training on Insomnia in Older Adults</brief_title>
  <official_title>Efficacy of Tai Chi Training to Alleviate Insomnia in Older Adults: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Angus Yu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Food and Health Bureau, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elderly insomnia is a serious public health problem. Current conventional approaches for&#xD;
      treating insomnia are not suitable or effective in elderly population. It has been previously&#xD;
      demonstrated that Tai Chi has definite advantages to be developed as self-help therapy in&#xD;
      older adults and has been preliminarily demonstrated to improve sleep in older people. This&#xD;
      project aims to evaluate the efficacy of Tai Chi training on alleviating chronic insomnia in&#xD;
      older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Elderly insomnia is a serious public health problem. It has been estimated over 50% of&#xD;
      elderly have sustained sleep complaints. About 20-40% of the elderly worldwide are reported&#xD;
      insomniac. In Hong Kong, a high proportion (38%) of older people have been reported to have&#xD;
      sleep disorders. These figures are alarming because insomnia associates with co-morbidities&#xD;
      including cognitive impairment, depression, mood/anxiety disorders, risks for falls,&#xD;
      hypertension, and heart disease in elderly. It also destructively affects daily functioning&#xD;
      by impairing the memory and reducing the attention span and response time. Most importantly,&#xD;
      insomnia has been evidently shown to link with the increased risk of hospitalization and&#xD;
      mortality. As the proportion of geriatric population is rapidly increasing, it is foreseeable&#xD;
      that the socioeconomic impact of elderly insomnia to the healthcare system will be&#xD;
      undoubtedly aggravated.&#xD;
&#xD;
      Current conventional approaches for treating insomnia are not suitable or effective in&#xD;
      elderly population. Pharmacologic treatment has always been a concern in insomniac senior&#xD;
      patients due to the adverse drug effects including dependence, abuse, cognitive impairment&#xD;
      and increase in risk of falls and hip fractures. With fewer adverse effects and consistent&#xD;
      efficacy, cognitive behavioral therapy (CBT) is taken as a more appropriate remedy for&#xD;
      elderly insomnia. However, the operation of effective CBT for insomnia is very labor&#xD;
      demanding and cost-ineffective. The large-scale use of CBT for elderly insomnia is not&#xD;
      feasible due to the shortage of CBT specialty-trained healthcare providers and the high&#xD;
      treatment cost. The limited availability of CBT treatment is far insufficient to match with&#xD;
      the increasingly large demand of insomniac elderly. There is another problem with the&#xD;
      conventional approaches. It is observed that most of the insomnia sufferers would not seek&#xD;
      timely clinical consultation and they tend to initiate self-help treatments when facing the&#xD;
      problem of insomnia. This situation is suggested to be more common in Chinese elderly due to&#xD;
      the traditional Confucius philosophy of reservation and quietness probably drive them more&#xD;
      likely to keep the problem to themselves and become reluctant to seek prompt clinical help&#xD;
      until serious medical symptom occurs. Given the prevalence of elderly insomnia is already&#xD;
      high and keeps increasing, there is an urgent need to explore other effective therapeutic&#xD;
      modalities preferably in forms of self-help remedies that can help to relieve the problem of&#xD;
      elderly insomnia.&#xD;
&#xD;
      Tai Chi has definite advantages to be developed as self-help therapy in older adults. Tai&#xD;
      Chi, a traditional form of Chinese fitness exercise, is a unique form of physical activity of&#xD;
      low impact and slow body movement, which includes a meditation component. It is a moderate&#xD;
      type of exercise that is well perceived to be suitable for regular practice by older&#xD;
      population. It is expected that Tai Chi is more acceptable to the elderly patients to be&#xD;
      incorporated with their daily life as an instant approach for remedying insomnia relative to&#xD;
      the conventional clinical treatment such as CBT. Additional advantages of Tai Chi include&#xD;
      low-cost and can be conveniently practiced at any time and any place without requirement for&#xD;
      extensive facilities. Certainly, the practice of Tai Chi is more accessible than the&#xD;
      conventional CBT treatment, which facilitates the large-scale use of Tai Chi to relieve&#xD;
      insomnia in elderly population. Furthermore, Tai Chi can be practiced individually or in a&#xD;
      group. If practicing in a group, Tai Chi provides additional benefit by serving as a vehicle&#xD;
      for establishing social interaction through which older people can establish friendship and&#xD;
      gain supports from other seniors.&#xD;
&#xD;
      Tai Chi has a number of beneficial effects on geriatric health and fitness. These health&#xD;
      benefits include improvements of aerobic fitness, energy metabolism, muscular strength and&#xD;
      balance. In addition to the improvements of cardiorespiratory function, bone loss, posture&#xD;
      stability and flexibility, Tai Chi exercise has also been shown to improve psychological&#xD;
      well-being via relieving symptoms of anxiety and depression and reducing mood disturbances.&#xD;
      All these physical and psychological advantages of Tai Chi cooperatively support its&#xD;
      prescription to the senior population.&#xD;
&#xD;
      Tai Chi has been preliminarily demonstrated to improve sleep in older people. Favorable&#xD;
      effects on sleep parameters have been reported in geriatric following 12 weeks to 6 months of&#xD;
      Tai Chi training. The self-reported sleep quality is demonstrated to be improved by a 12-week&#xD;
      of Tai Chi intervention in the senior residents in elderly home. Favorable effects of 12-week&#xD;
      of Tai Chi training in patients with chronic heart failure are reported by showing the&#xD;
      enhancement of sleep stability as assessed by sleep spectrogram. A longer period (6-month) of&#xD;
      Tai Chi training has also been shown to improve the Pittsburgh Sleep Quality Index&#xD;
      (PSQI)-indicated sleep quality in community-dwelling older adults. In older subjects with&#xD;
      moderate sleep complaint or sleep-disturbance, 24/25-week of Tai Chi training is shown to&#xD;
      improve the self-rated sleep quality, habitual sleep efficiency, sleep duration, and sleep&#xD;
      disturbance.&#xD;
&#xD;
      All these preliminary data collectively indicate the beneficial effects of Tai Chi on&#xD;
      improving sleep in geriatric population. Nonetheless, all these studies have a common design&#xD;
      limitation, which is the lack of direct objective sleep measures. With the study limitation&#xD;
      and research gaps, the present project is proposed to examine the therapeutic effects of Tai&#xD;
      Chi on chronic insomnia in elderly by including objective sleep measures. The findings of&#xD;
      this project are expected to have impact to unveil the efficacy of Tai Chi to alleviate&#xD;
      elderly insomnia, which has been an epidemic healthcare problem that necessitates to be&#xD;
      tackled promptly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Actigraphy-measured sleep onset latency</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention</time_frame>
    <description>Objectively measured sleep onset latency (min)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured sleep efficiency</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention</time_frame>
    <description>Objectively measured sleep efficiency (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured wake time after sleep onset</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention</time_frame>
    <description>Objectively measured wake time after sleep onset (min)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured total sleep time</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention</time_frame>
    <description>Objectively measured total sleep time (min)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured number of awakening</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention</time_frame>
    <description>Objectively measured number of awakening (number of times) after sleep onset</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured average wake time</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention</time_frame>
    <description>Objectively measured average wake time (min) of all awaken time after sleep onset</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured sleep onset latency</measure>
    <time_frame>24 months after the completion of intervention</time_frame>
    <description>Objectively measured sleep onset latency (min)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured Sleep efficiency</measure>
    <time_frame>24 months after the completion of intervention</time_frame>
    <description>Objectively measured sleep efficiency (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured wake time after sleep onset</measure>
    <time_frame>24 months after the completion of intervention</time_frame>
    <description>Objectively measured wake time after sleep onset (min)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured total sleep time</measure>
    <time_frame>24 months after the completion of intervention</time_frame>
    <description>Objectively measured total sleep time (min)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured number of awakening</measure>
    <time_frame>24 months after the completion of intervention</time_frame>
    <description>Objectively measured number of awakening (number of times) after sleep onset</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Actigraphy-measured average wake time</measure>
    <time_frame>24 months after the completion of intervention</time_frame>
    <description>Objectively measured average wake time (min) of all awaken time after sleep onset</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score of Pittsburgh Sleep Quality Index</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention</time_frame>
    <description>Pittsburgh Sleep Quality Index is a questionnaire that assess sleeping quality with scale ranged from 0 to 21. (A smaller score suggests a better sleep quality)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dose of Sleep Medication</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention</time_frame>
    <description>The change in dose of sleep medication used by the subjects after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Insomnia Severity Index</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention</time_frame>
    <description>Insomnia Severity Index is a questionnaire that assess sleeping quality with scale ranged from 0 to 28. (A smaller score suggests a better sleep quality)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>7-day Sleep Diary</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention</time_frame>
    <description>Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response rate</measure>
    <time_frame>Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention</time_frame>
    <description>The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate of insomnia</measure>
    <time_frame>Immediately after completion of the 12-week intervention and 24-month after the complete completion of the 12-week intervention</time_frame>
    <description>The percentage of participants that reached to remission of chronic insomnia according to DSM-5Immediately after the completion of the 12-week intervention</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Insomnia</condition>
  <condition>Poor Sleeping Quality</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in this group do not received any intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tai Chi Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Generic Fitness Intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Generic Fitness</intervention_name>
    <description>Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks</description>
    <arm_group_label>Generic Fitness Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tai Chi Intervention</intervention_name>
    <description>Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks</description>
    <arm_group_label>Tai Chi Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 years or older&#xD;
&#xD;
          -  ethnic Chinese&#xD;
&#xD;
          -  fulfill the DSM-V criteria for chronic insomnia including difficulties to initiate&#xD;
             sleep, maintain sleep or non-restorative sleep with complaint of impairment of daytime&#xD;
             functioning, sleep difficulty occurs at least 3 nights per week and is present for at&#xD;
             least three months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cannot walk without assistive tool (e.g., cane)&#xD;
&#xD;
          -  any serious somatic condition that prevent participation for Tai Chi/generic fitness&#xD;
             activities&#xD;
&#xD;
          -  current regular practicing of moderate exercise training or Tai Chi (&gt;3 times a week&#xD;
             of &gt;30-min per session)&#xD;
&#xD;
          -  any serious chronic diseases known to affect sleep (e.g., cancer and autoimmune&#xD;
             diseases)&#xD;
&#xD;
          -  under treatment of serious diseases known to affect sleep (e.g., cancer chemotherapy)&#xD;
&#xD;
          -  any chronic pain disorders known to affect sleep.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Parco MF Siu, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <zip>852</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <zip>852</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <zip>852</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 11, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Angus Yu</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Sleeping</keyword>
  <keyword>Quality</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), as well as the study protocol and the statistical analysis plan, will be shared, beginning 3 months and ending 5 years following publication of the Article. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to pmsiu@hku.hk to gain access, and data requestors will need to sign a data-access agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 5 years following publication of the Article</ipd_time_frame>
    <ipd_access_criteria>Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to pmsiu@hku.hk to gain access, and data requestors will need to sign a data-access agreement.</ipd_access_criteria>
  </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/NCT02260843
org study id: TaiChi and Insonmia
nct id: NCT02260843
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Elderly insomnia is a serious public health problem. Current conventional approaches for
      treating insomnia are not suitable or effective in elderly population. It has been previously
      demonstrated that Tai Chi has definite advantages to be developed as self-help therapy in
      older adults and has been preliminarily demonstrated to improve sleep in older people. This
      project aims to evaluate the efficacy of Tai Chi training on alleviating chronic insomnia in
      older adults.
Elderly insomnia is a serious public health problem. It has been estimated over 50% of
      elderly have sustained sleep complaints. About 20-40% of the elderly worldwide are reported
      insomniac. In Hong Kong, a high proportion (38%) of older people have been reported to have
      sleep disorders. These figures are alarming because insomnia associates with co-morbidities
      including cognitive impairment, depression, mood/anxiety disorders, risks for falls,
      hypertension, and heart disease in elderly. It also destructively affects daily functioning
      by impairing the memory and reducing the attention span and response time. Most importantly,
      insomnia has been evidently shown to link with the increased risk of hospitalization and
      mortality. As the proportion of geriatric population is rapidly increasing, it is foreseeable
      that the socioeconomic impact of elderly insomnia to the healthcare system will be
      undoubtedly aggravated.

      Current conventional approaches for treating insomnia are not suitable or effective in
      elderly population. Pharmacologic treatment has always been a concern in insomniac senior
      patients due to the adverse drug effects including dependence, abuse, cognitive impairment
      and increase in risk of falls and hip fractures. With fewer adverse effects and consistent
      efficacy, cognitive behavioral therapy (CBT) is taken as a more appropriate remedy for
      elderly insomnia. However, the operation of effective CBT for insomnia is very labor
      demanding and cost-ineffective. The large-scale use of CBT for elderly insomnia is not
      feasible due to the shortage of CBT specialty-trained healthcare providers and the high
      treatment cost. The limited availability of CBT treatment is far insufficient to match with
      the increasingly large demand of insomniac elderly. There is another problem with the
      conventional approaches. It is observed that most of the insomnia sufferers would not seek
      timely clinical consultation and they tend to initiate self-help treatments when facing the
      problem of insomnia. This situation is suggested to be more common in Chinese elderly due to
      the traditional Confucius philosophy of reservation and quietness probably drive them more
      likely to keep the problem to themselves and become reluctant to seek prompt clinical help
      until serious medical symptom occurs. Given the prevalence of elderly insomnia is already
      high and keeps increasing, there is an urgent need to explore other effective therapeutic
      modalities preferably in forms of self-help remedies that can help to relieve the problem of
      elderly insomnia.

      Tai Chi has definite advantages to be developed as self-help therapy in older adults. Tai
      Chi, a traditional form of Chinese fitness exercise, is a unique form of physical activity of
      low impact and slow body movement, which includes a meditation component. It is a moderate
      type of exercise that is well perceived to be suitable for regular practice by older
      population. It is expected that Tai Chi is more acceptable to the elderly patients to be
      incorporated with their daily life as an instant approach for remedying insomnia relative to
      the conventional clinical treatment such as CBT. Additional advantages of Tai Chi include
      low-cost and can be conveniently practiced at any time and any place without requirement for
      extensive facilities. Certainly, the practice of Tai Chi is more accessible than the
      conventional CBT treatment, which facilitates the large-scale use of Tai Chi to relieve
      insomnia in elderly population. Furthermore, Tai Chi can be practiced individually or in a
      group. If practicing in a group, Tai Chi provides additional benefit by serving as a vehicle
      for establishing social interaction through which older people can establish friendship and
      gain supports from other seniors.

      Tai Chi has a number of beneficial effects on geriatric health and fitness. These health
      benefits include improvements of aerobic fitness, energy metabolism, muscular strength and
      balance. In addition to the improvements of cardiorespiratory function, bone loss, posture
      stability and flexibility, Tai Chi exercise has also been shown to improve psychological
      well-being via relieving symptoms of anxiety and depression and reducing mood disturbances.
      All these physical and psychological advantages of Tai Chi cooperatively support its
      prescription to the senior population.

      Tai Chi has been preliminarily demonstrated to improve sleep in older people. Favorable
      effects on sleep parameters have been reported in geriatric following 12 weeks to 6 months of
      Tai Chi training. The self-reported sleep quality is demonstrated to be improved by a 12-week
      of Tai Chi intervention in the senior residents in elderly home. Favorable effects of 12-week
      of Tai Chi training in patients with chronic heart failure are reported by showing the
      enhancement of sleep stability as assessed by sleep spectrogram. A longer period (6-month) of
      Tai Chi training has also been shown to improve the Pittsburgh Sleep Quality Index
      (PSQI)-indicated sleep quality in community-dwelling older adults. In older subjects with
      moderate sleep complaint or sleep-disturbance, 24/25-week of Tai Chi training is shown to
      improve the self-rated sleep quality, habitual sleep efficiency, sleep duration, and sleep
      disturbance.

      All these preliminary data collectively indicate the beneficial effects of Tai Chi on
      improving sleep in geriatric population. Nonetheless, all these studies have a common design
      limitation, which is the lack of direct objective sleep measures. With the study limitation
      and research gaps, the present project is proposed to examine the therapeutic effects of Tai
      Chi on chronic insomnia in elderly by including objective sleep measures. The findings of
      this project are expected to have impact to unveil the efficacy of Tai Chi to alleviate
      elderly insomnia, which has been an epidemic healthcare problem that necessitates to be
      tackled promptly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Actigraphy-measured sleep onset latency
time frame: Immediately after completion of the 12 weeks intervention
description: Objectively measured sleep onset latency (min)
measure: Actigraphy-measured sleep efficiency
time frame: Immediately after completion of the 12 weeks intervention
description: Objectively measured sleep efficiency (%)
measure: Actigraphy-measured wake time after sleep onset
time frame: Immediately after completion of the 12 weeks intervention
description: Objectively measured wake time after sleep onset (min)
measure: Actigraphy-measured total sleep time
time frame: Immediately after completion of the 12 weeks intervention
description: Objectively measured total sleep time (min)
measure: Actigraphy-measured number of awakening
time frame: Immediately after completion of the 12 weeks intervention
description: Objectively measured number of awakening (number of times) after sleep onset
measure: Actigraphy-measured average wake time
time frame: Immediately after completion of the 12 weeks intervention
description: Objectively measured average wake time (min) of all awaken time after sleep onset
measure: Actigraphy-measured sleep onset latency
time frame: 24 months after the completion of intervention
description: Objectively measured sleep onset latency (min)
measure: Actigraphy-measured Sleep efficiency
time frame: 24 months after the completion of intervention
description: Objectively measured sleep efficiency (%)
measure: Actigraphy-measured wake time after sleep onset
time frame: 24 months after the completion of intervention
description: Objectively measured wake time after sleep onset (min)
measure: Actigraphy-measured total sleep time
time frame: 24 months after the completion of intervention
description: Objectively measured total sleep time (min)
measure: Actigraphy-measured number of awakening
time frame: 24 months after the completion of intervention
description: Objectively measured number of awakening (number of times) after sleep onset
measure: Actigraphy-measured average wake time
time frame: 24 months after the completion of intervention
description: Objectively measured average wake time (min) of all awaken time after sleep onset
measure: Score of Pittsburgh Sleep Quality Index
time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
description: Pittsburgh Sleep Quality Index is a questionnaire that assess sleeping quality with scale ranged from 0 to 21. (A smaller score suggests a better sleep quality)
measure: Change in dose of Sleep Medication
time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
description: The change in dose of sleep medication used by the subjects after intervention.
measure: Score of Insomnia Severity Index
time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
description: Insomnia Severity Index is a questionnaire that assess sleeping quality with scale ranged from 0 to 28. (A smaller score suggests a better sleep quality)
measure: 7-day Sleep Diary
time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
description: Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)
measure: Treatment response rate
time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
description: The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
measure: Remission rate of insomnia
time frame: Immediately after completion of the 12-week intervention and 24-month after the complete completion of the 12-week intervention
description: The percentage of participants that reached to remission of chronic insomnia according to DSM-5Immediately after the completion of the 12-week intervention
arm group label: Control
arm group type: No Intervention
description: Subjects in this group do not received any intervention.
arm group label: Tai Chi Intervention
arm group type: Active Comparator
description: Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks
arm group label: Generic Fitness Intervention
arm group type: Placebo Comparator
description: Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks
intervention type: Other
intervention name: Generic Fitness
description: Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks
arm group label: Generic Fitness Intervention
intervention type: Other
intervention name: Tai Chi Intervention
description: Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks
arm group label: Tai Chi Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Parco MF Siu, PHD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Angus Yu
investigator title: Research Assistant
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), as well as the study protocol and the statistical analysis plan, will be shared, beginning 3 months and ending 5 years following publication of the Article. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to pmsiu@hku.hk to gain access, and data requestors will need to sign a data-access agreement.
ipd info type: Study Protocol
ipd time frame: Beginning 3 months and ending 5 years following publication of the Article
ipd access criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to pmsiu@hku.hk to gain access, and data requestors will need to sign a data-access agreement.