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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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