Tai Chi for Patients With Essential Hypertension

Not Applicable

• Conditions: Hypertension
• Interventions: Behavioral: Tai Chi; Behavioral: Walking

• Registration Number: NCT04267471
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-12
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24
• Study Start: 2020-06
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

1. participants aged between 45 to 80 years;
2. 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);
3. participants with or without antihypertensive medication;
4. participants with no regular exercise in the past 3 months;
5. participants willing to comply with the study protocol;
6. participants willing to sign informed consent form.

Exclusion Criteria

1. participants diagnosed with secondary hypertension or refractory hypertension;
2. participants with severe medical visceral condition and chronic diseases, such as diabetes, epilepsy, severe depression or anxiety, psychosis;
3. participants with severe bone and joint diseases or motor dysfunction limit ability to participant exercise;
4. participants with severe cognitive decline (Mini-Mental State Examination score, ≤ 20)
5. participants with weak muscle, poor balance or limited vision that would impede full participation in the study;
6. patients participate in other clinical trials at the same time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai Chi	Tai Chi	3 sessions of Tai Chi per week for 12 weeks
Walking	Walking	3 sessions of walking per week for 12 weeks

Primary Outcome Measures

Name	Time	Method
average 24-h Systolic Blood Pressure (SBP)	change from baseline to 12 weeks after intervention

Secondary Outcome Measures

Name	Time	Method
average SBP and average Diastolic Blood Pressure (DBP)	baseline, after intervention(12 week), after follow-up(24 week)	average SBP and average DBP during the daytime and night-time
change of serum concentrations of Nitric Oxide	baseline, after intervention(12 week)
change of serum concentrations of vascular endothelial growth factor	baseline, after intervention(12 week)
change of serum concentrations of endothelin	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)
change of serum concentrations of thromboxane A2	baseline, after intervention(12 week)
Medical Outcomes Study 36-Item Short Form	baseline, after intervention(12 week)	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.

Trial Locations

Locations (1)

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine); 🇨🇳 Chengdu, Sichuan, China