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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Sleep Disturbance

Treatments: Other: repetitive transcranial magnetic stimulation; Behavioral: Tai Chi

Study type: Interventional

Funder types: Other

Identifiers

NCT05808517

V1

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

TC plus rTMS group

Experimental group

Description:

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.

Treatment:

Behavioral: Tai Chi

Other: repetitive transcranial magnetic stimulation

TC-alone group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Tai Chi

Treat-as-usual control group

No Intervention group

Description:

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.