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临床试验/NCT04403373
NCT04403373已完成不适用

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 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Depressive symptoms-Beck Depression Inventory (BDI)

研究概览

简要总结

  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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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;

结局指标

主要结局

Depressive symptoms-Beck Depression Inventory (BDI)

时间窗: 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

次要结局

  • 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)
  • Resting heart rate(3 Months)
  • Body Mass Index(3 Months)
  • Daily physical activity-International Physical Activity Questionnaire (IPAQ)(3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Parco M. Siu, PhD

Associate Professor & Head of Division of Kinesiology

The University of Hong Kong

研究点 (1)

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