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

NCT06411509 | Completed DMC

• 2 other identifiers: V2024-TMS1.51.56.BBCN
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance; Interaction

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity

  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.

  at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)

Secondary Outcomes (7)

• Actigraphy-assessed sleep parameters

  at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)

• Self-reported sleep parameters

  at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)

• Daytime sleepiness

  at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)

• Emotional states

  at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)

• Mental function and physical function

  at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)

Study Arms (4)

TC plus active rTMS

EXPERIMENTAL

Other: TC plus active rTMS

TC plus sham rTMS

SHAM COMPARATOR

Other: Tai Chi plus sham rTMS

TC-alone

EXPERIMENTAL

Behavioral: TC-alone

Low-intensity physical exercise

ACTIVE COMPARATOR

Behavioral: Low intensity physical exercise

Interventions

TC plus active rTMS OTHER

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.

TC plus active rTMS

Tai Chi plus sham rTMS OTHER

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.

TC plus sham rTMS

TC-alone BEHAVIORAL

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

TC-alone

Low intensity physical exercise BEHAVIORAL

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.

Low-intensity physical exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Hong Kong Polytechnic University, Department of Rehabilitation Sciences

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Parasomnias

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Hector Tsang, Professor

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proferssor

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 13, 2024
• Study Start: March 1, 2023
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

HK (1)