StrokeNCT03252236
Tai Chi Training in Stroke Survivors
A study testing Tai Chi and Conventional exercise in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Tai Chi and Conventional exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2014to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Tai Chi, Conventional exercise
- Keywords
- Stroke, Tai Chi, Dual-tasking, Arterial compliance, Arterial stiffness, Autonomic nervous system, Heart rate variability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Modified 12-form Yang style Tai Chi.
Conventional exerciseBehavioural
Conventional exercises included mobilization, stretching, muscle strengthening, and walking training.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | 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. Receives: Behavioral: Tai Chi |
| Conventional exercise | Active comparator | 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 Receives: Behavioral: Conventional exercise |
| Control | No intervention | No training was given to the subjects in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dual-tasking performance - turning-while-walking
A test combining a turning-while-walking test and an auditory Stroop test
Measured: week 0, week 12
Change in dual-tasking performance - stepping back
A test combining a stepping back test and an auditory Stroop test
Measured: week 0, week 12
Change in dual-tasking performance - stepping down
A test combining a stepping down test and an auditory Stroop test
Measured: week 0, week 12
Change in arterial compliance
Large and small arterial compliance measured non-invasively (HDI/PulsewaveTM CR-2000 Research CardioVascular Profiling System; Hypertension Diagnostics, Inc., Eagan, Minnesota, USA)
Measured: week 0, week 12
Secondary outcomes (5)
Single turning-while-walking test
A walking test in single-tasking condition
Measured: week 0, week 12, and week 16
Single stepping back test
Stepping back under single-tasking condition
Measured: week 0, week 12, and week 16
Single stepping down test
Stepping down under single-tasking condition
Measured: week 0, week 12, and week 16
Single auditory Stroop test
A cognitive task under single-tasking condition
Measured: week 0, week 12, and week 16
Heart rate variability
Tested the functioning of the cardiac autonomic nervous system
Measured: week 0, week 12, and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Oct 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William W. N. Tsang, The Hong Kong Polytechnic University
- Investigators
- William Wai Nam Tsang, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252236
- Sponsor's protocol ID
- HSEARS20131023003
- Status last verified
- Aug 2017
- First submitted
- 30 Jul 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mind-body Exercise on Cardiovascular Functions and Dual-tasking Performance in Chronic Stroke Survivors - a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03252236
- Acronym / sponsor ID
- HSEARS20131023003
- Conditions
- Stroke
- Keywords
- Stroke, Tai Chi, Dual-tasking, Arterial compliance, Arterial stiffness, Autonomic nervous system, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiSubjects 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. |
| Conventional exercise | Active comparator | Behavioral: Conventional exerciseSubjects 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 |
| Control | No intervention | –No training was given to the subjects in this group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiModified 12-form Yang style Tai Chi. | Behavioural | Tai Chi |
| Conventional exerciseConventional exercises included mobilization, stretching, muscle strengthening, and walking training. | Behavioural | Conventional exercise |
Primary outcome
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
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
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
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)
5 secondary outcomes
Single turning-while-walking test
Time frame: week 0, week 12, and week 16
Single stepping back test
Time frame: week 0, week 12, and week 16
Single stepping down test
Time frame: week 0, week 12, and week 16
Single auditory Stroop test
Time frame: week 0, week 12, and week 16
Heart rate variability
Time frame: week 0, week 12, and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Wai Nam Tsang, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Conventional exercise in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dual-tasking performance - turning-while-walking (time frame: week 0, week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.