<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/NCT03748797</url>
  </required_header>
  <id_info>
    <org_study_id>supervised exercise</org_study_id>
    <nct_id>NCT03748797</nct_id>
  </id_info>
  <brief_title>Effects of Supervised Exercise on Physical Health and Quality of Life Among Older HIV Adults</brief_title>
  <official_title>Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Society for AIDS Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Society for AIDS Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effects of exercise for older HIV-infected adults have not been well studied, especially&#xD;
      in Chinese population. This study aimed to investigate the effect of supervised exercise on&#xD;
      physical health and quality of life among older people living with HIV (PLWH) in Hong Kong.&#xD;
&#xD;
      HIV-infected adults were recruited from a community-based Non-Governmental Organization (NGO)&#xD;
      for HIV patient services. Participants were randomized into exercise group or control group.&#xD;
      The participants in exercise group performed an 8-week moderate intensity supervised exercise&#xD;
      program. In the control group, participants were not given any supervised exercises. They&#xD;
      were advised to continue their routine daily activities and self exercises.&#xD;
&#xD;
      Outcomes were measured for both groups at baseline and after 8 weeks. Primary outcomes: grip&#xD;
      strength, 30 seconds chair stand, 6 minutes-walk test and Short Form-36 questionnaire&#xD;
      (SF-36). Secondary outcome: Subjective improvement&#xD;
&#xD;
      At the end of the program, all participants from exercise group were interviewed individually&#xD;
      by principle investigator to allow feedbacks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a randomized controlled trial. HIV-infected adults were recruited from a&#xD;
      community-based Non-Governmental Organization (NGO) for HIV patient services.They were&#xD;
      randomized into exercise group or control group by drawing lots which contained equal number&#xD;
      of orange balls (exercise) and white balls (control)&#xD;
&#xD;
      The participants in exercise group performed an 8-week, 2 times/week supervised exercise&#xD;
      program in the community day center of the recruiting NGO. Exercise sessions were organized&#xD;
      in a group of 2 to 3 participants. The exercises were supervised by a registered&#xD;
      physiotherapist to ensure exercise safety and quality. Exercise intensity was moderate. We&#xD;
      monitored the heart rate of participants during exercise and maintained around 50% to 70% of&#xD;
      maximum heart rate. Blood pressure and oxygen saturation were also checked for safety&#xD;
      purposes. The mode of exercise was combined aerobic and resistance training. It involved&#xD;
      upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise,&#xD;
      dumb bell and squatting exercise. The duration for each exercise session was around 45&#xD;
      minutes. Duration and intensity of exercises were adjusted depending on the tolerance and&#xD;
      physical capacity of each participant. In the control group, participants were not given any&#xD;
      supervised exercises. They were advised to continue their routine daily activities and self&#xD;
      exercises. Control group participants were allowed to join into the same training program&#xD;
      after the research had finished.&#xD;
&#xD;
      Outcomes were measured for both groups at baseline and after 8 weeks in the same community&#xD;
      day center. A research assistant who was blinded for the participants grouping was&#xD;
      responsible for data collection. Physical health parameters included grip strength, 30&#xD;
      seconds chair stand and 6 minutes-walk test. Health related quality of life was measured by&#xD;
      Short Form-36 questionnaire (SF-36). Subjective improvement was taken in form of Likert&#xD;
      scale, from -100% to +100% with 10% interval in each possible response.&#xD;
&#xD;
      At the end of the program, all participants from exercise group were interviewed individually&#xD;
      by principle investigator to allow feedbacks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</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>
    <intervention_model_description>Exercise group: Performed an 8-week, 2 times/week exercise training (moderate intensity) under physiotherapist supervision.&#xD;
Control group: No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>A research assistant who was blinded for the participants grouping was responsible for data collection.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of SF-36 scores</measure>
    <time_frame>Change from Baseline SF-36 scores at 8 weeks</time_frame>
    <description>Short Form 36 (SF-36) questionnaire is used to assess health related quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Grip strength</measure>
    <time_frame>Change from Baseline grip strength at 8 weeks</time_frame>
    <description>Maximum grip strength of the participant in kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of 30 seconds chair stand</measure>
    <time_frame>Change from Baseline performance at 8 weeks</time_frame>
    <description>Number of times that the participant stand up and sit down within 30 seconds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of 6 minutes walk test</measure>
    <time_frame>Change from Baseline performance at 8 weeks</time_frame>
    <description>The distance (in meters) which the participant is able to walk in 6 minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective improvement</measure>
    <time_frame>Subjective change after 8 weeks compare to baseline</time_frame>
    <description>Subjective physical improvement reported by participant (from -100% to +100%)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week moderate intensity exercise training under supervision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moderate intensity exercise training under supervision</intervention_name>
    <description>Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise</description>
    <arm_group_label>Exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants with HIV age &gt; 50, treating with antiretroviral therapy&#xD;
&#xD;
          2. No contraindication to moderate intensity exercise&#xD;
&#xD;
          3. Independent Outdoor walker without assistance&#xD;
&#xD;
          4. Sedentry participants who have not received any structural / supervised exercise&#xD;
             program in the past 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;50&#xD;
&#xD;
          2. Unstable or unfit for exercise&#xD;
&#xD;
          3. Wheelchair user or assisted walker&#xD;
&#xD;
          4. Already had regular exercise habit or under structural exercise program in the past 1&#xD;
             year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chi Hong Chung, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Society for AIDS Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Society for AIDS Care Day Centre</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Society for AIDS Care</investigator_affiliation>
    <investigator_full_name>Chi Hong, CHUNG</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>HIV, exercise, aging, physical health, quality of life</keyword>
  <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/NCT03748797
org study id: supervised exercise
nct id: NCT03748797
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effects of exercise for older HIV-infected adults have not been well studied, especially
      in Chinese population. This study aimed to investigate the effect of supervised exercise on
      physical health and quality of life among older people living with HIV (PLWH) in Hong Kong.

      HIV-infected adults were recruited from a community-based Non-Governmental Organization (NGO)
      for HIV patient services. Participants were randomized into exercise group or control group.
      The participants in exercise group performed an 8-week moderate intensity supervised exercise
      program. In the control group, participants were not given any supervised exercises. They
      were advised to continue their routine daily activities and self exercises.

      Outcomes were measured for both groups at baseline and after 8 weeks. Primary outcomes: grip
      strength, 30 seconds chair stand, 6 minutes-walk test and Short Form-36 questionnaire
      (SF-36). Secondary outcome: Subjective improvement

      At the end of the program, all participants from exercise group were interviewed individually
      by principle investigator to allow feedbacks.
It is a randomized controlled trial. HIV-infected adults were recruited from a
      community-based Non-Governmental Organization (NGO) for HIV patient services.They were
      randomized into exercise group or control group by drawing lots which contained equal number
      of orange balls (exercise) and white balls (control)

      The participants in exercise group performed an 8-week, 2 times/week supervised exercise
      program in the community day center of the recruiting NGO. Exercise sessions were organized
      in a group of 2 to 3 participants. The exercises were supervised by a registered
      physiotherapist to ensure exercise safety and quality. Exercise intensity was moderate. We
      monitored the heart rate of participants during exercise and maintained around 50% to 70% of
      maximum heart rate. Blood pressure and oxygen saturation were also checked for safety
      purposes. The mode of exercise was combined aerobic and resistance training. It involved
      upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise,
      dumb bell and squatting exercise. The duration for each exercise session was around 45
      minutes. Duration and intensity of exercises were adjusted depending on the tolerance and
      physical capacity of each participant. In the control group, participants were not given any
      supervised exercises. They were advised to continue their routine daily activities and self
      exercises. Control group participants were allowed to join into the same training program
      after the research had finished.

      Outcomes were measured for both groups at baseline and after 8 weeks in the same community
      day center. A research assistant who was blinded for the participants grouping was
      responsible for data collection. Physical health parameters included grip strength, 30
      seconds chair stand and 6 minutes-walk test. Health related quality of life was measured by
      Short Form-36 questionnaire (SF-36). Subjective improvement was taken in form of Likert
      scale, from -100% to +100% with 10% interval in each possible response.

      At the end of the program, all participants from exercise group were interviewed individually
      by principle investigator to allow feedbacks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Exercise group: Performed an 8-week, 2 times/week exercise training (moderate intensity) under physiotherapist supervision.
Control group: No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: A research assistant who was blinded for the participants grouping was responsible for data collection.
measure: Change of SF-36 scores
time frame: Change from Baseline SF-36 scores at 8 weeks
description: Short Form 36 (SF-36) questionnaire is used to assess health related quality of life
measure: Change of Grip strength
time frame: Change from Baseline grip strength at 8 weeks
description: Maximum grip strength of the participant in kg
measure: Change of 30 seconds chair stand
time frame: Change from Baseline performance at 8 weeks
description: Number of times that the participant stand up and sit down within 30 seconds
measure: Change of 6 minutes walk test
time frame: Change from Baseline performance at 8 weeks
description: The distance (in meters) which the participant is able to walk in 6 minutes
measure: Subjective improvement
time frame: Subjective change after 8 weeks compare to baseline
description: Subjective physical improvement reported by participant (from -100% to +100%)
arm group label: Exercise group
arm group type: Experimental
description: 8-week moderate intensity exercise training under supervision
arm group label: Control group
arm group type: No Intervention
description: No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have
intervention type: Other
intervention name: Moderate intensity exercise training under supervision
description: Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise
arm group label: Exercise group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Chi Hong Chung, MSc
role: Principal Investigator
affiliation: The Society for AIDS Care
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Society for AIDS Care
investigator full name: Chi Hong, CHUNG
investigator title: Physiotherapist
sharing ipd: Undecided