An Integration of Tai Chi (TC) and Repetitive Transcranial Magnetic Stimulation (rTMS) for Sleep Disturbance in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- The change from baseline (T0) Insomnia Severity Index at immediately after the intervention (T1) and 3-month follow-up (T2)
研究概览
简要总结
The investigators designed an RCT aimed at 1) exploring the effectiveness of combining TC with rTMS for synergistically improving sleep disturbances in community-dwelling older adults, 2) investigating the mediating roles of arousal states as the underlying mechanism of the potential beneficial effects, and 3) evaluating the feasibility and safety to inform the clinical practice. The investigators hypothesized that integrating TC and rTMS can affect the different dimensions of the arousal system to improve sleep disturbances with optimized clinical outcomes.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classified with sleep disturbances (indications of poor sleep quality with a score >5 in Pittsburgh Sleep Quality Index)
- •Education level at primary or higher, and able to communicate in Cantonese (3) No experience of mind-body exercising such as TC, Qigong, or yoga within the past 6 months
排除标准
- •Serious visual or hearing difficulty
- •Active suicidal ideation or self-harm behaviors
- •Cognitive impairment (a score <26 in the Montreal Cognitive Assessment)
- •Comorbid diagnoses such as mental disorders, organic brain syndrome, or intellectual disabilities
- •Cardiac pacemaker, implanted medication pump, the intracranial implant (e.g., aneurism clips, shunts, stimulators, cochlear implants, or electrodes), or any other metal object within or near the head
- •Receiving other treatments or participating in other clinical trials during the same period
- •Current severe medical condition preventing physical exercise
研究组 & 干预措施
TC plus rTMS group
Participants received 12 one-hour sessions over 4 weeks (three times per week with a day between sessions). Each session of rTMS consisted of a sequence of three stimulation pulses per string with a string interval of 1 s (total 500 strings, total 1,500 stimulation pulses, and total stimulation time of 30 mins per session). After subjects finished each rTMS session, they immediately attended the TC class together with the participants in the TC-alone group.
干预措施: Tai Chi (Behavioral)
TC plus rTMS group
Participants received 12 one-hour sessions over 4 weeks (three times per week with a day between sessions). Each session of rTMS consisted of a sequence of three stimulation pulses per string with a string interval of 1 s (total 500 strings, total 1,500 stimulation pulses, and total stimulation time of 30 mins per session). After subjects finished each rTMS session, they immediately attended the TC class together with the participants in the TC-alone group.
干预措施: repetitive transcranial magnetic stimulation (Other)
TC-alone group
Participants underwent a 4-week intervention program consisting of simplified Yang style 12-Form Easy TC given as 1-hour sessions, three times per week. Each session included 5 to 10 minutes of warm-up exercise, 45 minutes of TC practice, and 5 to 10 minutes of cool-down exercise. The TC intervention was conducted in a small group format (i.e., 6-8) led by a trained TC instructor.
干预措施: Tai Chi (Behavioral)
Treat-as-usual control group
Participants in the TAU control group received treatments as usual for 4 weeks. No additional sleep intervention was provided. All participants were required to complete the subjective and objective assessments.
结局指标
主要结局
The change from baseline (T0) Insomnia Severity Index at immediately after the intervention (T1) and 3-month follow-up (T2)
时间窗: Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
次要结局
- The change from baseline (T0) somatic and cognitive arousal assessed by Pre-Sleep Arousal Scale at immediately after the intervention (T1) and 3-month follow-up (T2)(Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2))
- The change from baseline (T0) cortical arousal measured by 15 minutes eye-closed state electroencephalogram (EEG) at immediately after the intervention (T1) and 3-month follow-up (T2)(Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2))
- The change from baseline (T0) sleep pattern assessed by an objective measurement (wrist ActiGraph GT3X) at immediately after the intervention (T1) and 3-month follow-up (T2)(Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2))
- The change from baseline (T0) mood states assessed by Depression, Anxiety, and Stress Scale-21at immediately after the intervention (T1) and 3-month follow-up (T2)(Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2))
研究者
TSANG Hector Wing-Hong
Professor
The Hong Kong Polytechnic University