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

March 30, 2023 updated by: TSANG Hector Wing-Hong, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechinic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TC plus rTMS group
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.
Behavioral: Tai Chi
Tai Chi (TC) is a traditional Chinese exercise, also known as a mind-body exercise. It is suitable as an alternative or supplementary form of routine physical exercise for older adults. TC focuses on gentle and rhythmical movements while maintaining a meditative state. Low to moderate activities have benefits to improve sleep disturbances in older adults. In addition, growing evidence widely supports meditation as a potential intervention to improve sleep disturbances through reducing repetitive negative thoughts such as worry and rumination.
Other Names:
  • TC
Other: repetitive transcranial magnetic stimulation
The brain stimulation technique repetitive transcranial magnetic stimulation (rTMS) provides the opportunity to non-invasively modulate cortical excitability. In general, low-frequency rTMS (≤ 1 Hz) is thought to inhibit cortical excitability.
Other Names:
  • rTMS
Active Comparator: TC-alone group
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.
Behavioral: Tai Chi
Tai Chi (TC) is a traditional Chinese exercise, also known as a mind-body exercise. It is suitable as an alternative or supplementary form of routine physical exercise for older adults. TC focuses on gentle and rhythmical movements while maintaining a meditative state. Low to moderate activities have benefits to improve sleep disturbances in older adults. In addition, growing evidence widely supports meditation as a potential intervention to improve sleep disturbances through reducing repetitive negative thoughts such as worry and rumination.
Other Names:
  • TC
No Intervention: Treat-as-usual control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from baseline (T0) Insomnia Severity Index at immediately after the intervention (T1) and 3-month follow-up (T2)
Time Frame: Baseline (T0), 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

Outcome Measure
Time Frame
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)
Time Frame: Baseline (T0), 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)
Time Frame: Baseline (T0), 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)
Time Frame: Baseline (T0), 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)
Time Frame: Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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