Feasibility and Effects of a Blended Baduanjin Exercise and Green Tea Consumption Program on Depressive Symptoms, Gut Microbiota and Quality of Life in Older Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Self-reported depressive symptoms
研究概览
简要总结
Depression is a common mental health issue in older adults, often manifesting as insomnia, low mood, vague somatic complaints, cognitive decline, and recurrent thoughts of death or suicide. Even subthreshold depressive symptoms in late life significantly impair quality of life. In Hong Kong, recent data show high prevalence of depressive symptoms among community-dwelling older adults (43.7% in men, 54.8% in women), underscoring the urgent public health and economic need for effective interventions.
Although the previous evidence has shown that BDJ and GT consumption can improve depressive symptoms, gut microbiota, and QoL respectively, the feasibility and effect of the combination of two intervention approaches in older adults remain unclear. Therefore, the proposed study aims to (1) determine the feasibility of a 12-week blended BDJ and GT consumption program among Hong Kong community-dwelling older adults with depressive symptoms in a small-scale sample, and (2) examine the effects of the blended BDJ and GT consumption program on their depressive symptoms, gut-microbiota and QoL compared with that in the active control group.
详细描述
This study will be a single-blind 2-group RCT to examine the feasibility and the effects (immediate effects and 3-month residual effects) of the 12-week blended BDJ and GT consumption program on depressive symptoms, gut-microbiota and QoL among older adults with depressive symptoms. The target population will be Hong Kong community-dwelling older adults with depressive symptoms. Participants will be randomly assigned into one of two groups: a blended BDJ and GT consumption group and a control group. Evaluation will be conducted at pre-intervention (T1), post-intervention (T2), and 3-month after intervention completion (T3). Outcome assessors will be blinded from the assignment results to the intervention.
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)
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •community-dwelling older adults aged 65 to 84 years, who are youngest-old and middle-old with relatively stable health status compared with oldest-old aged 85 years and above
- •Scoring 5-15 using the Chinese version of Geriatric Depression Scale.
- •Access the smartphone and internet through which the Hospital Authority (HA) HA Go mobile app.
- •Pass the PAR-Q screening and no contraindications for physical exercise.
- •No history of smoking.
排除标准
- •suffer from cognitive impairment identified by the Chinese version of the Mini-Mental Status Examination (i.e., score < 24).
- •regularly consume tea or coffee (≥3 times/day, last for ≥6 months) as these habitual behaviors can contaminate the effects of tea consumption intervention per se.
- •Individuals with contraindications for tea consumption, such as insomnia, anemia, neurasthenia, hyperthyroidism, digestive ulcers, etc.
- •The concurrent use of sedative and tranquilizer medications, such as benzodiazepines and barbiturates.
- •take warfarin;
- •Participants are attending other health projects related to physical exercise and diet.
结局指标
主要结局
Self-reported depressive symptoms
时间窗: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 12-weeks intervention (T2 post-intervention), and 3 months after intervention completion (T3 follow-up test).
The Chinese version of the 15-item Geriatric Depression Scale (GDS-C) will be used to measure the subjective depression level. The GDS are the most widely used scales for the detection of depression symptoms in older adults (Cronbach's α = .81 -.83).
次要结局
- Gut-microbiota(Evaluations of stool test will be performed three times at pre-intervention (T1), the 12-week (3-month) post-intervention (T2), and the 3-month follow-up (T3) occasions.)
- Perceived quality of life(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 12-week intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test))