Exploring the Associations Among Frailty, Daily Physical Activity, Sleep, and Traditional Chinese Medicine Constitution in Taiwanese Older Adults, and Evaluating the Effects of Acupoint Stimulation Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Sleep Quality
研究概览
简要总结
This study aims to explore the relationships between frailty, daily physical activity, sleep quality, and Traditional Chinese Medicine (TCM) constitutions among older adults in Taiwan. In the trial phase, a randomized controlled trial will be conducted specifically for pre-frail older adults. Participants will be randomly assigned to either the exercise training group (Vivifrail program) or the integrated group combining exercise with daytime and sleep-improving acupoint stimulation. The study evaluates the combined efficacy of these non-invasive interventions on reducing frailty severity, improving sleep, and enhancing daily physical functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who are capable of undergoing frailty assessments.
- •Individuals who possess effective communication skills.
- •Aged 50 years or older.
- •Willing to provide written informed consent, keep a 7-day sleep diary, and complete related questionnaires.
- •Identified as pre-frail (frailty score of 1-2 points) according to the frailty phenotype criteria for the clinical trial phase.
排除标准
- •1. Individuals who are unwilling or unable to wear an actigraph (wrist monitor) or undergo physical measurements.
研究组 & 干预措施
Exercise Combined with Acupoint Stimulation
Participants receive a 12-week multimodal intervention, including the Vivifrail exercise program (daily, 45-60 minutes) and personalized daytime and sleep acupoint stimulation (2-3 times daily).
干预措施: Vivifrail Exercise Program (Behavioral)
Exercise Training Only
Participants receive the 12-week Vivifrail exercise program and sleep hygiene education, without any acupoint stimulation.
干预措施: Vivifrail Exercise Program (Behavioral)
Exercise Combined with Acupoint Stimulation
Participants receive a 12-week multimodal intervention, including the Vivifrail exercise program (daily, 45-60 minutes) and personalized daytime and sleep acupoint stimulation (2-3 times daily).
干预措施: Acupoint Stimulation (Other)
结局指标
主要结局
Change in Sleep Quality
时间窗: Baseline, Week 4, and Week 12
Measured via the Pittsburgh Sleep Quality Index (PSQI) questionnaire (global score ranges from 0 to 21, where higher scores indicate poorer sleep quality) and objective metrics from the 7-day wrist actigraphy (including total sleep time and sleep efficiency).
Change in Frailty Score
时间窗: Baseline, Week 4, and Week 12
Evaluated using the Fried frailty phenotype criteria, which includes five components: unintentional weight loss, weakness (grip strength), exhaustion, slowness (walking speed), and low physical activity. Each component is scored as 0 or 1, resulting in a total score ranging from 0 to 5. Higher scores indicate a worse outcome (higher severity of frailty).
次要结局
未报告次要终点
研究者
Yu-Ching HSU
Attending Physician
Tainan Hospital, Ministry of Health and Welfare