An Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults

Not Applicable

Completed

• Conditions: Sleep Disturbance
• Interventions: Behavioral: Tai Chi; Other: repetitive transcranial magnetic stimulation

• Registration Number: NCT05808517
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Classified with sleep disturbances (indications of poor sleep quality with a score >5 in Pittsburgh Sleep Quality Index)
2. 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

Exclusion Criteria

1. Serious visual or hearing difficulty
2. Active suicidal ideation or self-harm behaviors
3. Cognitive impairment (a score <26 in the Montreal Cognitive Assessment)
4. Comorbid diagnoses such as mental disorders, organic brain syndrome, or intellectual disabilities
5. 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
6. Receiving other treatments or participating in other clinical trials during the same period
7. Current severe medical condition preventing physical exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TC plus rTMS group	Tai Chi	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.
TC plus rTMS group	repetitive transcranial magnetic stimulation	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.
TC-alone group	Tai Chi	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.

Primary Outcome Measures

Name	Time	Method
The change from baseline (T0) Insomnia Severity Index 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)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

The Hong Kong Polytechinic University; 🇭🇰 Hong Kong, Hong Kong