Tai Chi for Patients With Essential Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04267471
• Other study ID #: 2019KL-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: December 2022

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Rongjiang Jin, PhD
• Phone: 13808072058
• Email: cdzyydxjrj[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 234
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Behavioral:
• Tai Chi
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.
• Walking
Each session of walking will last 60 minutes, including a 10-minute warm-up, a 40-minute walking and a 10-minutes cool-down.

Locations

Country	Name	City	State
China	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average 24-h Systolic Blood Pressure (SBP)		change from baseline to 12 weeks after intervention
Secondary	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)
Secondary	change of serum concentrations of Nitric Oxide		baseline, after intervention(12 week)
Secondary	change of serum concentrations of endothelin		baseline, after intervention(12 week)
Secondary	change of serum concentrations of thromboxane A2		baseline, after intervention(12 week)
Secondary	change of serum concentrations of vascular endothelial growth factor		baseline, after intervention(12 week)
Secondary	blood pressure measured at home with an upper arm electronic sphygmomanometer		baseline, after intervention(12 week), after follow-up(24 week)
Secondary	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)