Clinical trial NCT04267471: Tai Chi for Patients With Essential Hypertension
Official title: Tai Chi for Patients With Essential Hypertension: Study Protocol of an Open-label Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Tai Chi
Hypertension
Randomized Controlled Trial
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 234
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: average 24-h Systolic Blood Pressure (SBP)
timeFrame: change from baseline to 12 weeks after intervention
Secondary outcomes:
measure: average SBP and average Diastolic Blood Pressure (DBP)
timeFrame: baseline, after intervention(12 week), after follow-up(24 week)
measure: change of serum concentrations of Nitric Oxide
timeFrame: baseline, after intervention(12 week)
measure: change of serum concentrations of endothelin
timeFrame: baseline, after intervention(12 week)
measure: change of serum concentrations of thromboxane A2
timeFrame: baseline, after intervention(12 week)
measure: change of serum concentrations of vascular endothelial growth factor
timeFrame: baseline, after intervention(12 week)
measure: blood pressure measured at home with an upper arm electronic sphygmomanometer
timeFrame: baseline, after intervention(12 week), after follow-up(24 week)
measure: Medical Outcomes Study 36-Item Short Form
timeFrame: baseline, after intervention(12 week)
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Youping Liu, PhD
role: STUDY_CHAIR
References:
citation: Li Y, Zhong D, Dong C, Shi L, Zheng Y, Liu Y, Li Q, Zheng H, Li J, Liu T, Jin R. The effectiveness and safety of Tai Chi for patients with essential hypertension: study protocol for an open-label single-center randomized controlled trial. BMC Complement Med Ther. 2021 Jan 7;21(1):23. doi: 10.1186/s12906-020-03192-z.