Stroke, CardiovascularNCT04138407
Effects of Seated Tai Chi on Recovery Among Stroke Survivors
A study testing seated Tai Chi and Usual rehabilitation exercise in people with Stroke, Cardiovascular, run by Chinese University of Hong Kong.
Trial summary
A randomized controlled trial using seated Tai Chi (TC) as a rehabilitation intervention will be conducted among subacute stroke survivors. It aims to evaluate the effects of seated TC on recovery outcomes among subacute stroke survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cardiovascular
- What is being tested?
- seated Tai Chi and Usual rehabilitation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- A clinical diagnosis of ischaemic or haemorrhagic stroke;
- A history of first-ever stroke;
- In the subacute stage of stroke;
- Ability to sit independently with or without sitters;
- Ability to use and raise at least one arm while sitting (upper extremity muscle strength≥ Ⅲ);
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- Have a primary family caregiver (an unpaid relative, partner, personal friend, or neighbor who provides most assistance to the stroke survivor);
- Be able to communicate in Chinese and provide informed consent;
- Plan to be discharged home.
Who cannot join
- National Institutes of Health Stroke Scale score >16;
- Impaired cognitive functions (Abbreviated Mental Test, AMT ≤ 7);
- Severe hearing or visual impairment;
- Severe complications after stroke (e.g. limited comprehension and receptive aphasia, venous thrombosis);
- Severe history or existed medical condition (e.g. myocardial infarction, using a cardiac pacemaker or a defibrillator, organ failure, malignancy or mental diseases, another neurological disease: multiple sclerosis or parkinson disease, received thrombolytic therapy or surgery, received joint replacement surgeries or fractures within six months);
- Pregnant or lactating women;
- Prior regular (at least three times/week) Tai Chi practice or other mind-body exercise (e.g. Yoga, Qigong, Ba Duanjin, or mindfulness training) in the past six months;
- Participate in other clinical trials that would affect this study.
About this study
Official title: The Effects of Seated Tai Chi on Upper Limb Function, Balance Control, Depressive Symptoms, Activity of Daily Living and Quality of Life Among Subacute Stroke Survivors: A Randomized Controlled Trial
A randomized controlled trial using seated Tai Chi (TC) as a rehabilitation intervention will be conducted among subacute stroke survivors. It aims to evaluate the effects of seated TC on recovery outcomes among subacute stroke survivors.
Stroke survivors and their unpaid caregivers will be recruited as dyads participants. A number of 160 dyads will be recruited from a neurology department of a Tertiary A level provincial Traditional Chinese Medicine hospital in Mainland China with around 1700 beds.
Read more
The study will be conducted in hospital and homes. The participants will be randomly assigned to the seated TC group or the usual exercise group. The study will last for 12 weeks (two-week training in hospital and 10-week self-practice at home) and 4-week followup.
Stroke survivors in the seated TC group will participate a TC master-led, 30-minute seated TC exercise per day, five days per week for two weeks. When they discharge, they will perform the seated TC at home for 10 weeks. Those in the usual exercise group will receive usual exercise which has the same frequency and duration as the seated TC group. They will also perform self-practices at home for 10 weeks. Family caregivers will be encouraged to support the exercise intervention and help with recording the logbook of self-practice at home. Manual and training videos recorded by the same master will be given to the dyads of both groups to facilitate their continuation of self-practice on the day they discharge through WeChat. Biweekly reminder will be sent to the family caregivers by the PI through WeChat during the self-practice and follow-up period. The stroke survivors' upper limb function, balance control, depressive symptoms, activity of daily living, and quality of life will be measured at the following time point: baseline, after the supervised intervention (two weeks), eight weeks, after self-practice intervention (12 weeks) and at the end of follow-up (16 weeks). If the study finds significant effects on recovery among subacute stroke survivors, nursing professionals can act as care coordinators/ advocators to incorporate this culture-based exercise in stroke survivors' rehabilitation programs. Seated TC can be used as a clinically feasible exercise for nurses to work with other healthcare professionals for the promotion and application of evidence-based complementary and alternative therapy in promoting stroke survivors' recovery.
- Conditions
- Stroke, Cardiovascular
- Being tested
- seated Tai Chi, Usual rehabilitation exercise
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seated Tai ChiOther
Seated Tai Chi is a redesigned short form of traditional Tai Chi, can be practiced in a chair or wheelchair
Usual rehabilitation exerciseOther
Regular rehabilitation exercise used in participating hospital
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: seated Tai Chi |
| Control | Other | Usual rehabilitation exercise Receives: Other: Usual rehabilitation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of upper limb function in the body function and structure level
Upper limb function will be measured by Fugl-Meyer Test Upper Limb section. The scale includes eight items related to function of wrist and hand, evaluation results are on a three-point scale ranging from 0 ('unable accomplish') to 2 ('completely accomplish'), and has a maximum score of 66. Higher score indicates better upper limb function.
Measured: 0,2,8,12,16 weeks post-intervention
Change of upper limb function in the activity level
Upper limb function will be measured by Wolf Motor Function Test. It consists of 17 items including time, functional ability and strength domains. Item seven and 14 are strength test with recording the exact weight which the participants can afford. The remaining 15 items are scored ranging from 0 ('does not attempt') to 5 ('movement appears to be normal') and have a total score ranging from 0 to 75. Higher score indicates better function.
Measured: 0,2,8,12,16 weeks post-intervention
Change of balance control
Balance control will be measured by the Berg Balance Scale. Each item is scored ranging from zero to four and have a total score ranging from zero to 56. Higher score indicates better balance control.
Measured: 0,2,8,12,16 weeks post-intervention
Change of sitting balance control
Sitting balance control will be measured by the Trunk Impairment Scale. It consists of three subscales: static sitting balance, dynamic sitting balance and coordination. Each subscale contains three items, 10 items, and four items. The total score ranges from zero to 23 points. A higher score indicates better performance.
Measured: 0,2,8,12,16 weeks post-intervention
Change of depressive symptoms
The 15 items Geriatric Depression Scale short form version will be used to measure the depressive symptoms. Each item scored in a dichotomous format: 1= ('yes'), 0= ('no') in response to symptoms of depression. The total score is summed (range 0-15). Higher score indicates more serious depressive symptoms.
Measured: 0,2,8,12,16 weeks post-intervention
Secondary outcomes (2)
Change of activity of daily living
The Modified Barthel Index will be used to assess activity of daily living. The scale consists of 10 items to score the ability of a patient to care for himself which including feeding, moving, and toileting. The total scores range from 0 to 100. Higher score suggests better activity of daily living.
Measured: 0,2,8,12,16 weeks post-intervention
Change of quality of life
Quality of life will be assessed by Stroke-Specific Quality of Life Scale. It includes 12 areas affected following stroke covered by 49 items. For each item, there are five response options in which the score varies from one to five. Thus, the overall scores range from 49 (worst perception of quality of life) to 245 (best perception of quality of life). Higher scores indicate better quality of life.
Measured: 0,2,8,12,16 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study startFeb 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, CardiovascularStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHAO Jie, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138407
- Sponsor's protocol ID
- 2019.370
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao J, Chau JPC, Chan AWK, Meng Q, Choi KC, Xiang X, Zhao Y, He R, Li Q. Tailored Sitting Tai Chi Program for Subacute Stroke Survivors: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2192-2203. doi: 10.1161/STROKEAHA.121.036578. Epub 2022 Apr 7.
PubMed 35387494
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Seated Tai Chi on Upper Limb Function, Balance Control, Depressive Symptoms, Activity of Daily Living and Quality of Life Among Subacute Stroke Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04138407
- Acronym / sponsor ID
- 2019.370
- Conditions
- Stroke, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 24 Oct 2019 (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.
A randomized controlled trial using seated Tai Chi (TC) as a rehabilitation intervention will be conducted among subacute stroke survivors. It aims to evaluate the effects of seated TC on recovery outcomes among subacute stroke survivors.
Stroke survivors and their unpaid caregivers will be recruited as dyads participants. A number of 160 dyads will be recruited from a neurology department of a Tertiary A level provincial Traditional Chinese Medicine hospital in Mainland China with around 1700 beds.
The study will be conducted in hospital and homes. The participants will be randomly assigned to the seated TC group or the usual exercise group. The study will last for 12 weeks (two-week training in hospital and 10-week self-practice at home) and 4-week followup.
Stroke survivors in the seated TC group will participate a TC master-led, 30-minute seated TC exercise per day, five days per week for two weeks. When they discharge, they will perform the seated TC at home for 10 weeks. Those in the usual exercise group will receive usual exercise which has the same frequency and duration as the seated TC group. They will also perform self-practices at home for 10 weeks. Family caregivers will be encouraged to support the exercise intervention and help with recording the logbook of self-practice at home. Manual and training videos recorded by the same master will be given to the dyads of both groups to facilitate their continuation of self-practice on the day they discharge through WeChat. Biweekly reminder will be sent to the family caregivers by the PI through WeChat during the self-practice and follow-up period. The stroke survivors' upper limb function, balance control, depressive symptoms, activity of daily living, and quality of life will be measured at the following time point: baseline, after the supervised intervention (two weeks), eight weeks, after self-practice intervention (12 weeks) and at the end of follow-up (16 weeks). If the study finds significant effects on recovery among subacute stroke survivors, nursing professionals can act as care coordinators/ advocators to incorporate this culture-based exercise in stroke survivors' rehabilitation programs. Seated TC can be used as a clinically feasible exercise for nurses to work with other healthcare professionals for the promotion and application of evidence-based complementary and alternative therapy in promoting stroke survivors' recovery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: seated Tai Chi |
| Control | Other | Other: Usual rehabilitation exerciseUsual rehabilitation exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years;
- A clinical diagnosis of ischaemic or haemorrhagic stroke;
- A history of first-ever stroke;
- In the subacute stage of stroke;
- Ability to sit independently with or without sitters;
Key exclusion criteria (8 listed)
- National Institutes of Health Stroke Scale score >16;
- Impaired cognitive functions (Abbreviated Mental Test, AMT ≤ 7);
- Severe hearing or visual impairment;
- Severe complications after stroke (e.g. limited comprehension and receptive aphasia, venous thrombosis);
- Severe history or existed medical condition (e.g. myocardial infarction, using a cardiac pacemaker or a defibrillator, organ failure, malignancy or mental diseases, another neurological disease: multiple sclerosis or parkinson disease, received thrombolytic therapy or surgery, received joint replacement surgeries or fractures within 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 |
|---|---|---|
| seated Tai ChiSeated Tai Chi is a redesigned short form of traditional Tai Chi, can be practiced in a chair or wheelchair | Other | Intervention |
| Usual rehabilitation exerciseRegular rehabilitation exercise used in participating hospital | Other | Control |
Primary outcome
Change of upper limb function in the body function and structure level
Time frame: 0,2,8,12,16 weeks post-intervention
Upper limb function will be measured by Fugl-Meyer Test Upper Limb section. The scale includes eight items related to function of wrist and hand, evaluation results are on a three-point scale ranging from 0 ('unable accomplish') to 2 ('completely accomplish'), and has a maximum score of 66. Higher score indicates better upper limb function.
Change of upper limb function in the activity level
Time frame: 0,2,8,12,16 weeks post-intervention
Upper limb function will be measured by Wolf Motor Function Test. It consists of 17 items including time, functional ability and strength domains. Item seven and 14 are strength test with recording the exact weight which the participants can afford. The remaining 15 items are scored ranging from 0 ('does not attempt') to 5 ('movement appears to be normal') and have a total score ranging from 0 to 75. Higher score indicates better function.
Change of balance control
Time frame: 0,2,8,12,16 weeks post-intervention
Balance control will be measured by the Berg Balance Scale. Each item is scored ranging from zero to four and have a total score ranging from zero to 56. Higher score indicates better balance control.
Change of sitting balance control
Time frame: 0,2,8,12,16 weeks post-intervention
Sitting balance control will be measured by the Trunk Impairment Scale. It consists of three subscales: static sitting balance, dynamic sitting balance and coordination. Each subscale contains three items, 10 items, and four items. The total score ranges from zero to 23 points. A higher score indicates better performance.
Change of depressive symptoms
Time frame: 0,2,8,12,16 weeks post-intervention
The 15 items Geriatric Depression Scale short form version will be used to measure the depressive symptoms. Each item scored in a dichotomous format: 1= ('yes'), 0= ('no') in response to symptoms of depression. The total score is summed (range 0-15). Higher score indicates more serious depressive symptoms.
2 secondary outcomes
Change of activity of daily living
Time frame: 0,2,8,12,16 weeks post-intervention
Change of quality of life
Time frame: 0,2,8,12,16 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Derived from this study: PubMed 35387494Zhao J, Chau JPC, Chan AWK, Meng Q, Choi KC, Xiang X, Zhao Y, He R, Li Q. Tailored Sitting Tai Chi Program for Subacute Stroke Survivors: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2192-2203. doi: 10.1161/STROKEAHA.121.036578. Epub 2022 Apr 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing seated Tai Chi and Usual rehabilitation exercise in people with Stroke, Cardiovascular, run by Chinese University of 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 of upper limb function in the body function and structure level (time frame: 0,2,8,12,16 weeks post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04138407, which also lists 1 linked publication.
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 24 Oct 2019.