Clinical trial NCT04403373: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: MDD, Walking Exercise, Exercise Intensity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Depressive symptoms-Beck Depression Inventory (BDI)
timeFrame: 3 Months
Secondary outcomes:
measure: Antidepressants Usage-Medication History
timeFrame: 3 Months
measure: Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: 3 Months
measure: Sleep quality-Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 Months
measure: Quality of life-12-item short form health survey (SF-12)
timeFrame: 3 Months
measure: Cardiorespiratory fitness-VO2max Test
timeFrame: 3 Months
measure: Resting heart rate
timeFrame: 3 Months
measure: Body Mass Index
timeFrame: 3 Months
measure: Daily physical activity-International Physical Activity Questionnaire (IPAQ)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Li Kai Shing Faculty of Medicine
state: Southern District
Study officials:
affiliation: The University of Hong Kong
name: MING FAI P SIU, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.