<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/NCT04403373</url>
  </required_header>
  <id_info>
    <org_study_id>RF-9835-MDD-007</org_study_id>
    <nct_id>NCT04403373</nct_id>
  </id_info>
  <brief_title>Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study</brief_title>
  <official_title>Effectiveness of Different Intensities Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</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>
      1. This pilot randomized controlled trial aims at investigating the effects of different&#xD;
           intensities of aerobic walking exercise to alleviate depression in older adults with&#xD;
           major depressive disorder. Both baseline and post-intervention measurements will be&#xD;
           conducted at the Exercise Physiology Laboratory, Division of Kinesiology, School of&#xD;
           Public Health, The University of Hong Kong, while the exercise intervention will be&#xD;
           conducted outdoors in a small group setting (3-5 participants).&#xD;
&#xD;
        2. Three-time-per-week moderate-intensity (~3.5 METs) or vigorous-intensity (~7 METs)&#xD;
           walking exercise will be prescribed to participants in two exercise groups, while the&#xD;
           participants in the waitlist group will receive no intervention. The intervention&#xD;
           duration is 12 weeks.&#xD;
&#xD;
        3. We will recruit participants from the community in HK. Interested participants will be&#xD;
           invited for a semi-structured interview including an assessment on the Beck Depression&#xD;
           Inventory and medical history record to confirm eligibility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <masking_description>Outcomes assessor will be blinded from the group allocation and the participants are instructed not to reveal what kind of intervention he/she received.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive symptoms-Beck Depression Inventory (BDI)</measure>
    <time_frame>3 Months</time_frame>
    <description>BDI is a 21-item self-reporting questionnaire for evaluation of the severity of depression in both normal and psychiatric populations. Each item includes four statements numbered from 0 to 3, with a higher number indicating more severe depressive symptoms. Participants will be asked to circle the statement that can best describe them in a paper-pencil based manner. The BDI score interpretation is: less than 10: no or minimal depression, 10-18: mild-to-moderate depression, 19-29: moderate-to-severe depression, over 30: severe depression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antidepressants Usage-Medication History</measure>
    <time_frame>3 Months</time_frame>
    <description>The use of antidepressants such as most commonly prescribed Prozac (fluoxetine), Zoloft (sertraline), Lexapro (escitalopram), Paxil (paroxetine), Celexa (citalopram), or selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, with detailed usage information (e.g., drug name, type, dosage, and frequency of dosage) will be recorded. Subjects will be asked to provide the dosage, frequency of the daily antidepressant usage. The duration between the first interview of this study and the first diagnosis of MDD will also be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale</measure>
    <time_frame>3 Months</time_frame>
    <description>Generalized Anxiety Disorder 7-item (GAD-7) scale will be used to measure the anxiety level of the subjects. The GAD-7 is a reliable and valid measure of anxiety severity and its brevity make the GAD-7 a useful clinical and research tool. Higher score indicates more severe level of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality-Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>3 Months</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a standardized instrument to estimate sleep quantity and quality. The PSQI has been commonly used to distinguish people with primary insomnia from normal sleepers. The Chinese version of PSQI has been validated to have a satisfactory Cronbach's alpha of 0.82-0.83 and test-retest reliability of 0.85 among Hong Kong Chinese older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life-12-item short form health survey (SF-12)</measure>
    <time_frame>3 Months</time_frame>
    <description>SF-12 was originally developed for medical outcomes study, and it is one of the most widely used instruments for assessing health-related quality of life. SF-12 covers the same eight domains as the SF-36 form, which assesses physical functioning, emotional and mental health, body pain, general health, social functioning and vitality, with a higher score indicating a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory fitness-VO2max Test</measure>
    <time_frame>3 Months</time_frame>
    <description>The participant's maximal oxygen consumption will be measured at baseline, 12 weeks intervention to evaluate the participants' cardiovascular fitness by VO2max test using a COSMED Quark Series telemetric gas analysis system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting heart rate</measure>
    <time_frame>3 Months</time_frame>
    <description>The participant will be asked to sit quietly for 20 minutes for resting HR recording. The resting HR will be measured by Optical heart rate sensor (Polar OH1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>3 Months</time_frame>
    <description>Body weight and height of the subject will be measured by a validated scale (A&amp;D, UC-321) to the nearest 0.1kg and stadiometer (SECA, CE-0123) to the nearest 0.1cm. The BMI will be calculated as BMI = kg/m2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily physical activity-International Physical Activity Questionnaire (IPAQ)</measure>
    <time_frame>3 Months</time_frame>
    <description>The Chinese version of IPAQ is one of the most reliable self-report measures of physical activity for older adults, with intraclass correlation coefficients ranging from 0.81 to 0.89. Three categories of physical activities are classified in IPAQ: Low, moderate and high. Continuous score is also suggested to be expressed as MET-min per week, which can be calculated using the data from IPAQ.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Major Depressive Disorder (MDD)</condition>
  <arm_group>
    <arm_group_label>Waitlist control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in this group receive no intervention during the 12-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate-intensity walking group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will perform a thrice-a-week walking exercise at a moderate intensity (~3.5 METs). The training will be conducted outdoors. Each training session lasts for 50 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vigorous-intensity walking group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will perform a thrice-a-week walking exercise at a vigorous intensity (~7 METs). The training will be conducted outdoors. Each training session lasts for 25 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Waitlist control</intervention_name>
    <description>waitlist control</description>
    <arm_group_label>Waitlist control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Moderate-intensity walking exercise</intervention_name>
    <description>walking exercise</description>
    <arm_group_label>Moderate-intensity walking group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vigorous-intensity walking exercise</intervention_name>
    <description>walking exercise</description>
    <arm_group_label>Vigorous-intensity walking group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Older adults aged equal or over 50 years;&#xD;
&#xD;
          2. Ethnic Chinese;&#xD;
&#xD;
          3. Beck Depression Inventory score over 9 points;&#xD;
&#xD;
          4. Diagnosed with MDD and currently on pharmacological treatment for MDD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Incapable of participating in physical exercise with major confounding conditions&#xD;
             which are known to affect mobility;&#xD;
&#xD;
          2. Cannot walk without assistive device;&#xD;
&#xD;
          3. Regular exercise habit (defined as exercise &gt; 3 times per week and each time &gt; 50&#xD;
             minutes)&#xD;
&#xD;
          4. Any serious somatic condition that prevents walking exercise participation (such as&#xD;
             limb loss)&#xD;
&#xD;
          5. History of major diseases e.g. cancer, cardio-/cerebrovascular, neurodegenerative and&#xD;
             renal diseases;&#xD;
&#xD;
          6. Diagnosis of dementia/Alzheimer's disease, or currently using antidementia medication;&#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>MING FAI P SIU, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Li Kai Shing Faculty of Medicine</name>
      <address>
        <city>Hong Kong</city>
        <state>Southern District</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Parco M. Siu, PhD</investigator_full_name>
    <investigator_title>Associate Professor &amp; Head of Division of Kinesiology</investigator_title>
  </responsible_party>
  <keyword>MDD, Walking Exercise, Exercise Intensity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 3 years following the publication of the article</ipd_time_frame>
    <ipd_access_criteria>Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.</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/NCT04403373
org study id: RF-9835-MDD-007
nct id: NCT04403373
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
1. This pilot randomized controlled trial aims at investigating the effects of different
           intensities of aerobic walking exercise to alleviate depression in older adults with
           major depressive disorder. Both baseline and post-intervention measurements will be
           conducted at the Exercise Physiology Laboratory, Division of Kinesiology, School of
           Public Health, The University of Hong Kong, while the exercise intervention will be
           conducted outdoors in a small group setting (3-5 participants).

        2. Three-time-per-week moderate-intensity (~3.5 METs) or vigorous-intensity (~7 METs)
           walking exercise will be prescribed to participants in two exercise groups, while the
           participants in the waitlist group will receive no intervention. The intervention
           duration is 12 weeks.

        3. We will recruit participants from the community in HK. Interested participants will be
           invited for a semi-structured interview including an assessment on the Beck Depression
           Inventory and medical history record to confirm eligibility.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes assessor will be blinded from the group allocation and the participants are instructed not to reveal what kind of intervention he/she received.
measure: Depressive symptoms-Beck Depression Inventory (BDI)
time frame: 3 Months
description: BDI is a 21-item self-reporting questionnaire for evaluation of the severity of depression in both normal and psychiatric populations. Each item includes four statements numbered from 0 to 3, with a higher number indicating more severe depressive symptoms. Participants will be asked to circle the statement that can best describe them in a paper-pencil based manner. The BDI score interpretation is: less than 10: no or minimal depression, 10-18: mild-to-moderate depression, 19-29: moderate-to-severe depression, over 30: severe depression
measure: Antidepressants Usage-Medication History
time frame: 3 Months
description: The use of antidepressants such as most commonly prescribed Prozac (fluoxetine), Zoloft (sertraline), Lexapro (escitalopram), Paxil (paroxetine), Celexa (citalopram), or selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, with detailed usage information (e.g., drug name, type, dosage, and frequency of dosage) will be recorded. Subjects will be asked to provide the dosage, frequency of the daily antidepressant usage. The duration between the first interview of this study and the first diagnosis of MDD will also be recorded.
measure: Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale
time frame: 3 Months
description: Generalized Anxiety Disorder 7-item (GAD-7) scale will be used to measure the anxiety level of the subjects. The GAD-7 is a reliable and valid measure of anxiety severity and its brevity make the GAD-7 a useful clinical and research tool. Higher score indicates more severe level of anxiety.
measure: Sleep quality-Pittsburgh Sleep Quality Index (PSQI)
time frame: 3 Months
description: The Pittsburgh Sleep Quality Index (PSQI) is a standardized instrument to estimate sleep quantity and quality. The PSQI has been commonly used to distinguish people with primary insomnia from normal sleepers. The Chinese version of PSQI has been validated to have a satisfactory Cronbach's alpha of 0.82-0.83 and test-retest reliability of 0.85 among Hong Kong Chinese older adults.
measure: Quality of life-12-item short form health survey (SF-12)
time frame: 3 Months
description: SF-12 was originally developed for medical outcomes study, and it is one of the most widely used instruments for assessing health-related quality of life. SF-12 covers the same eight domains as the SF-36 form, which assesses physical functioning, emotional and mental health, body pain, general health, social functioning and vitality, with a higher score indicating a better quality of life.
measure: Cardiorespiratory fitness-VO2max Test
time frame: 3 Months
description: The participant's maximal oxygen consumption will be measured at baseline, 12 weeks intervention to evaluate the participants' cardiovascular fitness by VO2max test using a COSMED Quark Series telemetric gas analysis system.
measure: Resting heart rate
time frame: 3 Months
description: The participant will be asked to sit quietly for 20 minutes for resting HR recording. The resting HR will be measured by Optical heart rate sensor (Polar OH1).
measure: Body Mass Index
time frame: 3 Months
description: Body weight and height of the subject will be measured by a validated scale (A&D, UC-321) to the nearest 0.1kg and stadiometer (SECA, CE-0123) to the nearest 0.1cm. The BMI will be calculated as BMI = kg/m2.
measure: Daily physical activity-International Physical Activity Questionnaire (IPAQ)
time frame: 3 Months
description: The Chinese version of IPAQ is one of the most reliable self-report measures of physical activity for older adults, with intraclass correlation coefficients ranging from 0.81 to 0.89. Three categories of physical activities are classified in IPAQ: Low, moderate and high. Continuous score is also suggested to be expressed as MET-min per week, which can be calculated using the data from IPAQ.
arm group label: Waitlist control group
arm group type: Placebo Comparator
description: Participants in this group receive no intervention during the 12-week period.
arm group label: Moderate-intensity walking group
arm group type: Experimental
description: Participants in this group will perform a thrice-a-week walking exercise at a moderate intensity (~3.5 METs). The training will be conducted outdoors. Each training session lasts for 50 minutes.
arm group label: Vigorous-intensity walking group
arm group type: Experimental
description: Participants in this group will perform a thrice-a-week walking exercise at a vigorous intensity (~7 METs). The training will be conducted outdoors. Each training session lasts for 25 minutes.
intervention type: Behavioral
intervention name: Waitlist control
description: waitlist control
arm group label: Waitlist control group
intervention type: Behavioral
intervention name: Moderate-intensity walking exercise
description: walking exercise
arm group label: Moderate-intensity walking group
intervention type: Behavioral
intervention name: Vigorous-intensity walking exercise
description: walking exercise
arm group label: Vigorous-intensity walking group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: MING FAI P SIU, Ph.D
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Parco M. Siu, PhD
investigator title: Associate Professor & Head of Division of Kinesiology
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: Yes
ipd description: The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 3 months and ending 3 years following the publication of the article
ipd access criteria: Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.