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Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study

Primary Purpose

Major Depressive Disorder (MDD)

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Waitlist control
Moderate-intensity walking exercise
Vigorous-intensity walking exercise
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder (MDD) focused on measuring MDD, Walking Exercise, Exercise Intensity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Older adults aged equal or over 50 years;
  2. Ethnic Chinese;
  3. Beck Depression Inventory score over 9 points;
  4. Diagnosed with MDD and currently on pharmacological treatment for MDD.

Exclusion Criteria:

  1. Incapable of participating in physical exercise with major confounding conditions which are known to affect mobility;
  2. Cannot walk without assistive device;
  3. Regular exercise habit (defined as exercise > 3 times per week and each time > 50 minutes)
  4. Any serious somatic condition that prevents walking exercise participation (such as limb loss)
  5. History of major diseases e.g. cancer, cardio-/cerebrovascular, neurodegenerative and renal diseases;
  6. Diagnosis of dementia/Alzheimer's disease, or currently using antidementia medication;

Sites / Locations

  • Li Kai Shing Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Waitlist control group

Moderate-intensity walking group

Vigorous-intensity walking group

Arm Description

Participants in this group receive no intervention during the 12-week period.

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.

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.

Outcomes

Primary Outcome Measures

Depressive symptoms-Beck Depression Inventory (BDI)
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

Secondary Outcome Measures

Antidepressants Usage-Medication History
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.
Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale
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.
Sleep quality-Pittsburgh Sleep Quality Index (PSQI)
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.
Quality of life-12-item short form health survey (SF-12)
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.
Cardiorespiratory fitness-VO2max Test
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.
Resting heart rate
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).
Body Mass Index
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.
Daily physical activity-International Physical Activity Questionnaire (IPAQ)
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.

Full Information

First Posted
May 21, 2020
Last Updated
May 3, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04403373
Brief Title
Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study
Official Title
Effectiveness of Different Intensities Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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). 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder (MDD)
Keywords
MDD, Walking Exercise, Exercise Intensity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist control group
Arm Type
Placebo Comparator
Arm Description
Participants in this group receive no intervention during the 12-week period.
Arm Title
Moderate-intensity walking group
Arm Type
Experimental
Arm 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 Title
Vigorous-intensity walking group
Arm Type
Experimental
Arm 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(s)
Waitlist control
Intervention Description
waitlist control
Intervention Type
Behavioral
Intervention Name(s)
Moderate-intensity walking exercise
Intervention Description
walking exercise
Intervention Type
Behavioral
Intervention Name(s)
Vigorous-intensity walking exercise
Intervention Description
walking exercise
Primary Outcome Measure Information:
Title
Depressive symptoms-Beck Depression Inventory (BDI)
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
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Antidepressants Usage-Medication History
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.
Time Frame
3 Months
Title
Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale
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.
Time Frame
3 Months
Title
Sleep quality-Pittsburgh Sleep Quality Index (PSQI)
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.
Time Frame
3 Months
Title
Quality of life-12-item short form health survey (SF-12)
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.
Time Frame
3 Months
Title
Cardiorespiratory fitness-VO2max Test
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.
Time Frame
3 Months
Title
Resting heart rate
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).
Time Frame
3 Months
Title
Body Mass Index
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.
Time Frame
3 Months
Title
Daily physical activity-International Physical Activity Questionnaire (IPAQ)
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.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older adults aged equal or over 50 years; Ethnic Chinese; Beck Depression Inventory score over 9 points; Diagnosed with MDD and currently on pharmacological treatment for MDD. Exclusion Criteria: Incapable of participating in physical exercise with major confounding conditions which are known to affect mobility; Cannot walk without assistive device; Regular exercise habit (defined as exercise > 3 times per week and each time > 50 minutes) Any serious somatic condition that prevents walking exercise participation (such as limb loss) History of major diseases e.g. cancer, cardio-/cerebrovascular, neurodegenerative and renal diseases; Diagnosis of dementia/Alzheimer's disease, or currently using antidementia medication;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MING FAI P SIU, Ph.D
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Kai Shing Faculty of Medicine
City
Hong Kong
State/Province
Southern District
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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 Sharing Time Frame
Beginning 3 months and ending 3 years following the publication of the article
IPD Sharing 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.
Citations:
PubMed Identifier
35579606
Citation
Yu DJ, Yu AP, Leung CK, Chin EC, Fong DY, Cheng CP, Yau SY, Siu PM. Comparison of moderate and vigorous walking exercise on reducing depression in middle-aged and older adults: A pilot randomized controlled trial. Eur J Sport Sci. 2023 Jun;23(6):1018-1027. doi: 10.1080/17461391.2022.2079424. Epub 2022 Jun 13.
Results Reference
derived

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Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study

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