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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Interaction; Sleep Disturbance

Treatments: Other: TC plus active rTMS; Other: Tai Chi plus sham rTMS; Behavioral: Low intensity physical exercise; Behavioral: TC-alone

Study type: Interventional

Funder types: Other

Identifiers

NCT06411509

1.51.56.BBCN (Other Grant/Funding Number)

V2024-TMS

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age of at least 60 years
2. 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
3. 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
4. Provide written informed consent

Exclusion criteria

1. Cognitive impairment as determined by the Montreal Cognitive Assessment scored less than 22
2. Major confounding conditions known to induce sleep perturbations, such as psychiatric disorders or chronic pain disorder
3. History of head injury or epilepsy, intracranial implant, cardiac pacemaker, or any other contraindication to rTMS
4. Obvious physical disability that precluded participant in the interventions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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152 participants in 4 patient groups

TC plus active rTMS

Experimental group

Treatment:

Other: TC plus active rTMS

TC plus sham rTMS

Sham Comparator group

Treatment:

Other: Tai Chi plus sham rTMS

TC-alone

Experimental group

Treatment:

Behavioral: TC-alone

Low-intensity physical exercise

Active Comparator group

Treatment:

Behavioral: Low intensity physical exercise