Tai Chi for Patients With Essential Hypertension

Study Overview
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Brief Summary
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Several studies investigating Tai Chi for hypertension have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of Tai Chi for essential hypertension.

Official Title
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Tai Chi for Patients With Essential Hypertension: Study Protocol of an Open-label Single-center Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Tai Chi
* Behavioral: Walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants aged between 45 to 80 years; participants diagnosed with mild to moderate hypertension, and meet the diagnostic criteria of mild to moderate hypertension according to 2018 Chinese guidelines for the management of hypertension (140≤SBP≤169 and/or 90≤DBP≤109); participants with or without antihypertensive medication; participants with no regular exercise in the past 3 months; participants willing to comply with the study protocol; participants willing to sign informed consent form. Exclusion Criteria: participants diagnosed with secondary hypertension or refractory hypertension; participants with severe medical visceral condition and chronic diseases, such as diabetes, epilepsy, severe depression or anxiety, psychosis; participants with severe bone and joint diseases or motor dysfunction limit ability to participant exercise; participants with severe cognitive decline (Mini-Mental State Examination score, ≤ 20) participants with weak muscle, poor balance or limited vision that would impede full participation in the study; patients participate in other clinical trials at the same time.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi<br>3 sessions of Tai Chi per week for 12 weeks | Behavioral: Tai Chi<br>* Tai Chi is a traditional Chinese mind-body exercise, which combines deep-breath relaxation and gentle movements in sequence with meditation. Each session of Tai Chi will last 60 minutes, including a 10-minute warm-up, a 40-minute Tai Chi practice and a 10-minute cool-down.<br>* Other names: Tai Ji Quan;|
| Active Comparator: Walking<br>3 sessions of walking per week for 12 weeks | Behavioral: Walking<br>* Each session of walking will last 60 minutes, including a 10-minute warm-up, a 40-minute walking and a 10-minutes cool-down.<br>|
| No Intervention: Waiting-list<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average 24-h Systolic Blood Pressure (SBP) |  | change from baseline to 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average SBP and average Diastolic Blood Pressure (DBP) | average SBP and average DBP during the daytime and night-time | baseline, after intervention(12 week), after follow-up(24 week) | 
| change of serum concentrations of Nitric Oxide |  | baseline, after intervention(12 week) | 
| change of serum concentrations of endothelin |  | baseline, after intervention(12 week) | 
| change of serum concentrations of thromboxane A2 |  | baseline, after intervention(12 week) | 
| change of serum concentrations of vascular endothelial growth factor |  | baseline, after intervention(12 week) | 
| blood pressure measured at home with an upper arm electronic sphygmomanometer |  | baseline, after intervention(12 week), after follow-up(24 week) | 
| Medical Outcomes Study 36-Item Short Form | This scale contains eight dimensions (physical function, role physical, bodily pain, general health, vitality, social function, role emotional, mental health) and two summary components (physical and mental), with score from 0 to 100. High scores indicate a better quality of life. | baseline, after intervention(12 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tai Chi, Hypertension, Randomized Controlled Trial