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Tai Chi Training in Stroke Survivors

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Tai Chi
Conventional exercise
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Tai Chi, Dual-tasking, Arterial compliance, Arterial stiffness, Autonomic nervous system, Heart rate variability

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Tai Chi

Conventional exercise

Control

Arm Description

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.

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

No training was given to the subjects in this group

Outcomes

Primary Outcome Measures

Change in dual-tasking performance - turning-while-walking
A test combining a turning-while-walking test and an auditory Stroop test
Change in dual-tasking performance - stepping back
A test combining a stepping back test and an auditory Stroop test
Change in dual-tasking performance - stepping down
A test combining a stepping down test and an auditory Stroop test
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)

Secondary Outcome Measures

Single turning-while-walking test
A walking test in single-tasking condition
Single stepping back test
Stepping back under single-tasking condition
Single stepping down test
Stepping down under single-tasking condition
Single auditory Stroop test
A cognitive task under single-tasking condition
Heart rate variability
Tested the functioning of the cardiac autonomic nervous system

Full Information

First Posted
July 30, 2017
Last Updated
August 16, 2017
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03252236
Brief Title
Tai Chi Training in Stroke Survivors
Official Title
Effects of Mind-body Exercise on Cardiovascular Functions and Dual-tasking Performance in Chronic Stroke Survivors - a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Tai Chi, Dual-tasking, Arterial compliance, Arterial stiffness, Autonomic nervous system, Heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional exercise
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
No training was given to the subjects in this group
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
Modified 12-form Yang style Tai Chi.
Intervention Type
Behavioral
Intervention Name(s)
Conventional exercise
Intervention Description
Conventional exercises included mobilization, stretching, muscle strengthening, and walking training.
Primary Outcome Measure Information:
Title
Change in dual-tasking performance - turning-while-walking
Description
A test combining a turning-while-walking test and an auditory Stroop test
Time Frame
week 0, week 12
Title
Change in dual-tasking performance - stepping back
Description
A test combining a stepping back test and an auditory Stroop test
Time Frame
week 0, week 12
Title
Change in dual-tasking performance - stepping down
Description
A test combining a stepping down test and an auditory Stroop test
Time Frame
week 0, week 12
Title
Change in arterial compliance
Description
Large and small arterial compliance measured non-invasively (HDI/PulsewaveTM CR-2000 Research CardioVascular Profiling System; Hypertension Diagnostics, Inc., Eagan, Minnesota, USA)
Time Frame
week 0, week 12
Secondary Outcome Measure Information:
Title
Single turning-while-walking test
Description
A walking test in single-tasking condition
Time Frame
week 0, week 12, and week 16
Title
Single stepping back test
Description
Stepping back under single-tasking condition
Time Frame
week 0, week 12, and week 16
Title
Single stepping down test
Description
Stepping down under single-tasking condition
Time Frame
week 0, week 12, and week 16
Title
Single auditory Stroop test
Description
A cognitive task under single-tasking condition
Time Frame
week 0, week 12, and week 16
Title
Heart rate variability
Description
Tested the functioning of the cardiac autonomic nervous system
Time Frame
week 0, week 12, and week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Wai Nam Tsang, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Tai Chi Training in Stroke Survivors

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