Tai Chi Training in Stroke Survivors

August 16, 2017 updated by: William W. N. Tsang, The Hong Kong Polytechnic University

Effects of Mind-body Exercise on Cardiovascular Functions and Dual-tasking Performance in Chronic Stroke Survivors - a Randomized Controlled Clinical Trial

People with stroke suffer from different impairments, including the ability to dual-tasking, increased arterial stiffness, and dysfunction of the autonomic nervous system. The decrement in dual-tasking performance has been found among stroke survivors, and the deterioration has been related to increased risk of fall in the population. No coherent result has been concluded from previous studies investigating the effect of different types of exercise training on enhancing dual-tasking performance among healthy older adults and stroke survivors.

Increased arterial stiffness and impaired functioning of the autonomic nervous systems, which have been associated with increased cardiovascular risk and mortality, are common in stroke survivors. Studies have been suggesting the beneficial effects of aerobic exercise on both decreasing arterial stiffness and regulating the autonomic nervous system among healthy older people. However, only a few studies concerning such topic have been conducted among stroke survivors, yet the results were inconsistent.

Tai Chi is a Chinese traditional martial art and has been employed as a rehabilitation exercise in recent decades. Tai Chi practitioners should perform the physical movement and plan the Tai Chi forms simultaneously. The involvement of cognitive functioning gives Tai Chi a dual-tasking character. Prior studies demonstrated the beneficial effect of Tai Chi training on dual-tasking performance in healthy older adults, but would the effect extend to stroke survivors has not yet been studied.

Also, Tai Chi is considered as a mind-body exercise. It is suggested that one should keep a relaxed status of mind and breathe gently and slowly. Moreover, Tai Chi is an exercise with moderate intensity. These features have been found to decrease arterial stiffness and benefit functioning of the autonomic nervous system. Indeed, studies have been showing Tai Chi reduces arterial stiffness and improves regulation of the autonomic nervous system among healthy population. Whether such effect can be observed in stroke survivors is still unknown.

This study aimed at investigating the effects of Tai Chi training on dual-tasking performance, arterial stiffness, and autonomic system functioning among stroke survivors. Given the special features of Tai Chi and its advantageous effects on the mentioned functioning, it is expected that stroke survivors may also benefit from Tai Chi training.

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.

Detailed Description

Previous studies have been showing a deterioration of dual-tasking performance among stroke survivors, especially when a dynamic physical task is involved. Dual-tasking performance has been associated with risk of fall among stroke survivors. Results of prior studies on investigating the effect of conventional exercise on dual-tasking performance in the population have not been reaching a consistent conclusion.

Apart from the ability to dual-tasking, cardiovascular functioning, such as increased arterial stiffness and dysfunction of the cardiac autonomic system, has also been found compromised in stroke survivors. Such deterioration has been related to increased cardiovascular risk and mortality. Research has been suggesting the beneficial effect of aerobic exercise with moderate or high intensity on improving both the arterial stiffness and autonomic functioning in healthy older adults.

Tai Chi is a Chinese traditional martial art and has been adopted as a rehabilitation exercise in recent decades. Tai Chi can be considered as a dual-tasking exercise as its practitioners should perform the physical movement, monitoring their action, and plan for the next Tai Chi form simultaneously. Besides, Tai Chi is an exercise with moderate intensity. It is also a mind-body exercise which emphasizes on maintaining a relaxed status of mind during the practice. The mental status can be achieved by its meditation feature, as well as synchronizing the Tai Chi movement with gentle, slow and deep breathing. The mind-body characteristics of Tai Chi were similar to those factors proposed to improve the functioning of the autonomic nervous system. Indeed, previous studies have been suggesting the beneficial effects of Tai Chi training on dual-tasking performance, arterial compliance, and autonomic regulation among healthy older adults. However, its effects on these functioning among stroke survivors have not yet been established.

Given the characteristics of Tai Chi and previous studies on its therapeutic effects among healthy older adults, the exercise may also benefit stroke survivors. This randomized controlled trial, therefore, is designed to investigate the effect of Tai Chi training on dual-tasking performance, arterial compliance, and functioning of the cardiac autonomic nervous system among stroke survivors. The investigators expected that these functions would be improved after Tai Chi training and the training effects would be better than those of the conventional exercise in stroke survivors. If Tai Chi is found beneficial to dual-tasking, vascular function, and autonomic regulation, the exercise may incorporate into the rehabilitation program.

Eligible subjects (please refer to the 'Eligibility' part for inclusion and exclusion criteria) were randomized into one of the three groups: Tai Chi, conventional exercise, or control (please refer to the 'Arms and Interventions' part for details of each group). The dual-tasking performance was assessed with three different physical tasks: turning-while-walking, stepping back, and stepping down. These physical tasks were included as they are common in daily life among community-dwelling stroke survivors but can also be challenging to them. Moreover, these activities were among the most prevalent reasons for fall among stroke survivors. Other assessment employed in this study can be found in the 'Outcome Measures' part. Assessment was conducted before, after, and one month after the intervention period.

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.
56

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 Polytechnic 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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with stroke six or more months previously
  • Able to perform a stepping down maneuver without any physical assistance
  • Able to walk unaided for 5m indoor
  • Able to follow instructions in Cantonese

Exclusion Criteria:

  • Any neurological disease other than stroke
  • Severe visual or hearing impairment
  • A score of less than 18 on the Cantonese version of the Mini-Mental Status Examination (MMSE)
  • Any major surgery or severe musculoskeletal injury during the previous six months

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
  • Masking: SINGLE

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: Tai Chi
Subjects in this group were trained with Tai Chi exercise. The training lasted for 12 weeks, one hour per session and twice a week. Subjects were asked to practice outside of the class 30 minutes at least once a week.
Behavioral: Tai Chi
Modified 12-form Yang style Tai Chi.
ACTIVE_COMPARATOR: Conventional exercise
Subjects in this group were trained with conventional exercises. Subjects were also asked to practice the exercises outside of the class 30 minutes at least once a week
Behavioral: Conventional exercise
Conventional exercises included mobilization, stretching, muscle strengthening, and walking training.
NO_INTERVENTION: Control
No training was given to the subjects in this group

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
Measure Description
Time Frame
Change in dual-tasking performance - turning-while-walking
Time Frame: week 0, week 12
A test combining a turning-while-walking test and an auditory Stroop test
week 0, week 12
Change in dual-tasking performance - stepping back
Time Frame: week 0, week 12
A test combining a stepping back test and an auditory Stroop test
week 0, week 12
Change in dual-tasking performance - stepping down
Time Frame: week 0, week 12
A test combining a stepping down test and an auditory Stroop test
week 0, week 12
Change in arterial compliance
Time Frame: week 0, week 12
Large and small arterial compliance measured non-invasively (HDI/PulsewaveTM CR-2000 Research CardioVascular Profiling System; Hypertension Diagnostics, Inc., Eagan, Minnesota, USA)
week 0, week 12

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
Measure Description
Time Frame
Single turning-while-walking test
Time Frame: week 0, week 12, and week 16
A walking test in single-tasking condition
week 0, week 12, and week 16
Single stepping back test
Time Frame: week 0, week 12, and week 16
Stepping back under single-tasking condition
week 0, week 12, and week 16
Single stepping down test
Time Frame: week 0, week 12, and week 16
Stepping down under single-tasking condition
week 0, week 12, and week 16
Single auditory Stroop test
Time Frame: week 0, week 12, and week 16
A cognitive task under single-tasking condition
week 0, week 12, and week 16
Heart rate variability
Time Frame: week 0, week 12, and week 16
Tested the functioning of the cardiac autonomic nervous system
week 0, week 12, and week 16

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Wai Nam Tsang, PhD, 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.
October 1, 2014

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, 2016

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, 2016

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).
July 30, 2017

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.
August 14, 2017

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.
August 17, 2017

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.
August 21, 2017

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.
August 16, 2017

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.
August 1, 2017

More Information

Terms related to this study

Keywords

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.
  • HSEARS20131023003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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