NCT04403373

Brief Summary

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

May 21, 2020

Last Update Submit

May 3, 2021

Conditions

Major Depressive Disorder (MDD)

Keywords

MDD, Walking Exercise, Exercise Intensity

Outcome Measures

Primary Outcomes (1)

  • 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

    3 Months

Secondary Outcomes (8)

  • Antidepressants Usage-Medication History

    3 Months

  • Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale

    3 Months

  • Sleep quality-Pittsburgh Sleep Quality Index (PSQI)

    3 Months

  • Quality of life-12-item short form health survey (SF-12)

    3 Months

  • Cardiorespiratory fitness-VO2max Test

    3 Months

  • +3 more secondary outcomes

Study Arms (3)

Waitlist control group

PLACEBO COMPARATOR

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

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.

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.

Behavioral: Vigorous-intensity walking exercise

Interventions

Waitlist controlBEHAVIORAL

waitlist control

Waitlist control group
Moderate-intensity walking exerciseBEHAVIORAL

walking exercise

Moderate-intensity walking group
Vigorous-intensity walking exerciseBEHAVIORAL

walking exercise

Vigorous-intensity walking group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Li Kai Shing Faculty of Medicine

Hong Kong, Southern District, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 35579606DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • MING FAI P SIU, Ph.D

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will be blinded from the group allocation and the participants are instructed not to reveal what kind of intervention he/she received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & Head of Division of Kinesiology

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

November 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months and ending 3 years following the publication of the article
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.

Locations

HK(1)