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

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.

Conditions

• Sleep Disturbance
• Interaction

Interventions

OTHER

TC plus active rTMS

The rTMS intervention is performed using a MagPro X100 by MagVenture with a water-cooled figure-of-eight coil. Before the treatment session, the resting motor threshold of the left abductor pollicis brevis is determined. The rMT is defined as the minimum intensity which produces five motor evoked potential responses of at least 50 μV in 10 trials at rest. A protocol of 1 Hz rTMS at 80% of RMT is applied over the frontal area of the right DLPFC. The coil position is localized using a frameless stereotactic neuronavigation system (TMS-Navigator, Localite GmbH, Bonn, Germany). Participants receive only three sessions of TC per week without rTMS during in the week 1 and 2, and the TC potocol is same as the TC-alone group. Participants receive daily rTMS (30 minutes) for 5 days a week combined with three sessions of TC in the last 2 weeks. Active rTMS deliveres at 1 Hz for 30 min (1800 pulses per session) with the intensity of 80% rMT.

OTHER

Tai Chi plus sham rTMS

Sham rTMS is administrated the same procedures as the active rTMS but with low intensity of 20% rMT to elicit similar skin sensations and sounds. The TC protocol in this group is the same as the TC-alone group.

BEHAVIORAL

TC-alone

Participants in the TC-alone group attend a simplified Yang style 8-Form Easy TC training program in a group format. Each session lasts for 60 minutes and are conducted three times per week over a period of four weeks. In the first session, the certified TC instructor explains the exercise theory and procedures. The remaining sessions includes 5 to 10 minutes warm-up and a review of TC principles, 45 minutes meditative movements, and 5 to 10 minutes cool-down

BEHAVIORAL

Low intensity physical exercise

To achieve the same exercise volume with TC-alone group, participants in the low-intensity physical exercise control group attend a four-week exercise training in group format. Exercise sessions are 60 minutes with three times per week. Each exercise session consists of 5 to 10 minutes warm-up, 45 minutes of aerobic training, and a 5 to 10 minutes cool-down.

Sponsors & Collaborators

• The Hong Kong Polytechnic University

  lead OTHER

Principal Investigators

• Hector Tsang, Professor · Hong Kong Polytechnic University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2024-04-28

Completion

2024-04-28

Countries

• Hong Kong

Study Locations