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Clinical Trials/NCT04403373
NCT04403373CompletedNot Applicable

Effectiveness of Different Intensities Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Randomized Controlled Trial

The University of Hong Kong1 site in 1 country35 target enrollmentStarted: November 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
1
Primary Endpoint
Depressive symptoms-Beck Depression Inventory (BDI)

Study Overview

Brief 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. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
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.

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;

Arms & Interventions

Waitlist control group

Placebo Comparator

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

Intervention: Waitlist control (Behavioral)

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.

Intervention: Moderate-intensity walking exercise (Behavioral)

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.

Intervention: Vigorous-intensity walking exercise (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale(3 Months)
  • Antidepressants Usage-Medication History(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)
  • Resting heart rate(3 Months)
  • Body Mass Index(3 Months)
  • Daily physical activity-International Physical Activity Questionnaire (IPAQ)(3 Months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Parco M. Siu, PhD

Associate Professor & Head of Division of Kinesiology

The University of Hong Kong

Study Sites (1)

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