Clinical trial NCT04138407: Effects of Seated Tai Chi on Recovery Among Stroke Survivors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Cardiovascular
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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);
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of upper limb function in the body function and structure level
timeFrame: 0,2,8,12,16 weeks post-intervention
measure: Change of upper limb function in the activity level
timeFrame: 0,2,8,12,16 weeks post-intervention
measure: Change of balance control
timeFrame: 0,2,8,12,16 weeks post-intervention
measure: Change of sitting balance control
timeFrame: 0,2,8,12,16 weeks post-intervention
measure: Change of depressive symptoms
timeFrame: 0,2,8,12,16 weeks post-intervention
Secondary outcomes:
measure: Change of activity of daily living
timeFrame: 0,2,8,12,16 weeks post-intervention
measure: Change of quality of life
timeFrame: 0,2,8,12,16 weeks post-intervention
Other outcomes:
Locations:
Study officials:
References:
citation: 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.