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

NCT ID: NCT04403373

Last Updated: 2021-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder (MDD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor will be blinded from the group allocation and the participants are instructed not to reveal what kind of intervention he/she received.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Waitlist control group

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

Group Type PLACEBO_COMPARATOR

Waitlist control

Intervention Type BEHAVIORAL

waitlist control

Moderate-intensity walking group

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.

Group Type EXPERIMENTAL

Moderate-intensity walking exercise

Intervention Type BEHAVIORAL

walking exercise

Vigorous-intensity walking group

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.

Group Type EXPERIMENTAL

Vigorous-intensity walking exercise

Intervention Type BEHAVIORAL

walking exercise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Waitlist control

waitlist control

Intervention Type BEHAVIORAL

Moderate-intensity walking exercise

walking exercise

Intervention Type BEHAVIORAL

Vigorous-intensity walking exercise

walking exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Parco M. Siu, PhD

Associate Professor & Head of Division of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MING FAI P SIU, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Li Kai Shing Faculty of Medicine

Hong Kong, Southern District, Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35579606 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RF-9835-MDD-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.