Major Depressive Disorder (MDD)NCT04403373
Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study
A study testing Moderate-intensity walking exercise and Vigorous-intensity walking exercise in people with Major Depressive Disorder (MDD), run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Moderate-intensity walking exercise and Vigorous-intensity walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Li Kai Shing Faculty of Medicine
Hong Kong, Southern District
About this study
Official title: Effectiveness of Different Intensities Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Randomized Controlled Trial
- 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Waitlist control, Moderate-intensity walking exercise, Vigorous-intensity walking exercise
- Keywords
- MDD, Walking Exercise, Exercise Intensity
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waitlist controlBehavioural
waitlist control
Moderate-intensity walking exerciseBehavioural
walking exercise
Vigorous-intensity walking exerciseBehavioural
walking exercise
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control group | Placebo comparator | Participants in this group receive no intervention during the 12-week period. Receives: Behavioral: Waitlist control |
| Moderate-intensity walking group | Experimental | 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. Receives: Behavioral: Moderate-intensity walking exercise |
| Vigorous-intensity walking group | Experimental | 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. Receives: Behavioral: Vigorous-intensity walking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 Months
Secondary outcomes (8)
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.
Measured: 3 Months
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.
Measured: 3 Months
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.
Measured: 3 Months
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.
Measured: 3 Months
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.
Measured: 3 Months
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).
Measured: 3 Months
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.
Measured: 3 Months
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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Nov 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parco M. Siu, PhD, The University of Hong Kong
- Investigators
- MING FAI P SIU, Ph.D, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403373
- Sponsor's protocol ID
- RF-9835-MDD-007
- Status last verified
- May 2021
- First submitted
- 21 May 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35579606
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Intensities Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04403373
- Acronym / sponsor ID
- RF-9835-MDD-007
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- MDD, Walking Exercise, Exercise Intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waitlist control group | Placebo comparator | Behavioral: Waitlist controlParticipants in this group receive no intervention during the 12-week period. |
| Moderate-intensity walking group | Experimental | Behavioral: Moderate-intensity walking exerciseParticipants 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. |
| Vigorous-intensity walking group | Experimental | Behavioral: Vigorous-intensity walking exerciseParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Waitlist controlwaitlist control | Behavioural | Waitlist control group |
| Moderate-intensity walking exercisewalking exercise | Behavioural | Moderate-intensity walking group |
| Vigorous-intensity walking exercisewalking exercise | Behavioural | Vigorous-intensity walking group |
Primary outcome
Depressive symptoms-Beck Depression Inventory (BDI)
Time frame: 3 Months
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
8 secondary outcomes
Antidepressants Usage-Medication History
Time frame: 3 Months
Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale
Time frame: 3 Months
Sleep quality-Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 Months
Quality of life-12-item short form health survey (SF-12)
Time frame: 3 Months
Cardiorespiratory fitness-VO2max Test
Time frame: 3 Months
Resting heart rate
Time frame: 3 Months
Body Mass Index
Time frame: 3 Months
Daily physical activity-International Physical Activity Questionnaire (IPAQ)
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Derived from this study: PubMed 35579606Yu 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MING FAI P SIU, Ph.D principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity walking exercise and Vigorous-intensity walking exercise in people with Major Depressive Disorder (MDD), run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms-Beck Depression Inventory (BDI) (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.