NCT03252236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

July 30, 2017

Last Update Submit

August 16, 2017

Conditions

Keywords

StrokeTai ChiDual-taskingArterial complianceArterial stiffnessAutonomic nervous systemHeart rate variability

Outcome Measures

Primary Outcomes (4)

  • Change in dual-tasking performance - turning-while-walking

    A test combining a turning-while-walking test and an auditory Stroop test

    week 0, week 12

  • Change in dual-tasking performance - stepping back

    A test combining a stepping back test and an auditory Stroop test

    week 0, week 12

  • Change in dual-tasking performance - stepping down

    A test combining a stepping down test and an auditory Stroop test

    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)

    week 0, week 12

Secondary Outcomes (5)

  • Single turning-while-walking test

    week 0, week 12, and week 16

  • Single stepping back test

    week 0, week 12, and week 16

  • Single stepping down test

    week 0, week 12, and week 16

  • Single auditory Stroop test

    week 0, week 12, and week 16

  • Heart rate variability

    week 0, week 12, and week 16

Study Arms (3)

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.

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

Behavioral: Conventional exercise

Control

NO INTERVENTION

No training was given to the subjects in this group

Interventions

Tai ChiBEHAVIORAL

Modified 12-form Yang style Tai Chi.

Tai Chi

Conventional exercises included mobilization, stretching, muscle strengthening, and walking training.

Conventional exercise

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • William Wai Nam Tsang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Head

Study Record Dates

First Submitted

July 30, 2017

First Posted

August 17, 2017

Study Start

October 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations