Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults
- Conditions
- InteractionSleep Disturbance
- Interventions
- Other: TC plus active rTMSBehavioral: Low intensity physical exerciseOther: Tai Chi plus sham rTMSBehavioral: TC-alone
- Registration Number
- NCT06411509
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
This is a novel and the first study to investigate the impacts of the integrated treatment of Tai Chi (TC) and repetitive transcranial magnetic stimulation (rTMS) on sleep disturbances and the potential mechanisms of arousal system. To validate the combination of TC and rTMS as a promising approach for managing sleep disturbance in older adults, the investigators will conduct a four-arm, parallel-group, randomized controlled trial comprising a 4-week treatment phase and a 3-month follow up period. A total of 152 eligible participants will be recruited and randomly assign to the TC plus active rTMS (38 participants), TC plus sham rTMS (38 participants), TC-alone (38 participants), and low-intensity PE (38 participants) control group within two weeks after the baseline assessment. TC plus active rTMS, TC plus sham rTMS, and TC-alone will be compared with a low-intensity PE control group on insomnia severity, various sleep parameters assessed by self-report sleep diary and ActiGraph, emotional states, and physical and mental health related quality of life. The investigators have formulated two hypotheses in this study. First, the three intervention groups, relative to participants undergoing PE, will confer greater improvement in all measured outcomes at post-intervention (T1) and three-month follow-up (T2); and second, in the double-blinded groups, the TC plus active rTMS will show greater improvement in all measured outcomes than TC plus sham rTMS at T1 and T2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- Age of at least 60 years
- Active sleep disturbance as indicated by the Pittsburgh Sleep Quality Index (PSQI) score exceeding 5 and the Insomnia Severity Index (ISI) score greater than 7 at screening
- No prior experience of mind-body exercises (i.e., TC, Qigong, or yoga, etc.) and regular moderate-intensity exercise (i.e., above three times per week and 30 minutes per session) in the past 6 months
- Provide written informed consent
- Cognitive impairment as determined by the Montreal Cognitive Assessment scored less than 22
- Major confounding conditions known to induce sleep perturbations, such as psychiatric disorders or chronic pain disorder
- History of head injury or epilepsy, intracranial implant, cardiac pacemaker, or any other contraindication to rTMS
- Obvious physical disability that precluded participant in the interventions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TC plus active rTMS TC plus active rTMS - Low-intensity physical exercise Low intensity physical exercise - TC plus sham rTMS Tai Chi plus sham rTMS - TC-alone TC-alone -
- Primary Outcome Measures
Name Time Method Insomnia Severity at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up) Measured by Insomnia Severity Index, it's a 7-item questionnaire assessing insomnia severity over the past two weeks. Items scored 0 to 4 and total score range is from 0 to 28. Total score of 7 or less indicate no clinically significant insomnia, 8 to 14 indicate subthreshold insomnia, and 15 or greater indicate moderate to severe insomnia.
- Secondary Outcome Measures
Name Time Method Actigraphy-assessed sleep parameters at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up) Collected from a wrist ActiGraph wGT3X-BT on the nondominant hand for 7 consecutive days.
Self-reported sleep parameters at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up) Derived from a consensus sleep diary for 7 days
Daytime sleepiness at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up) Evaluated by the Epworth sleepiness scale (ESS). The ESS is used to rate the possibility to doze off or fall asleep. Items scored 0 to 3 and the sum ranges from 0 to 24. The total score exceeds 10 suggests signifies pathological sleepiness, and higher values reflects greater severity.
Cortical arousal at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up) EEG data are collected using the DSI-24 wearable EEG device for 5 minutes in the resting state with eyes closed. Spectral power analysis and functional connectivity analysis will be conducted. Participants with lower cortical arousal shows a decrease in beta- and gamma-band power during the wakefulness eye-closed resting state. In addition, decreased connectivity in the default mode network and increased connectivity in fronto-parietal network is also suggested the improvements of cortical arousal.
Emotional states at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up) Measured by Depression, Anxiety, and Stress Scale-21 Items. Each subscale has seven items that are scored on a 4-point Likert scale (0=not at all to 3=most of the time). More severe symptoms are indicated by higher scores.
Mental function and physical function at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up) The self-reported quality of life is measured by the Short Form 36-item Health Survey (SF-36) (Brazier et al. 1992). In the SF-36, the data are presented as physical component score (PCS) and mental component score (MCS). Each domain is valued from 0 to 100, with higher score denoting better health status.
Somatic arousal and cognitive arousal at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up) Somatic arousal and cognitive arousal are assessed by the the Pre-Sleep Arousal Scale (PSAS). The PSAS is a 16-item self-reported questionnaire that assesses the state of arousal when falling asleep and is composed of somatic and cognitive arousal subscales with eight items in each. The somatic subscale (PSAS somatic) contains items addressing physical arousal such as racing heart, muscle tension, and rapid breathing. The cognitive subscale (PSAS cognitive) contains items on the worry about falling asleep, being mentally alert at bedtime, and the inability to shut off one's thoughts. Each subscale item is scored on a scale from 1 (not at all) to 5 (extremely). Total scores for each of the subscales can range from 8 to 40, with higher scores associated with greater arousal.
Trial Locations
- Locations (1)
Hong Kong Polytechnic University, Department of Rehabilitation Sciences
ðŸ‡ðŸ‡°Kowloon, Hong Kong