Tai Chi for Patients With Essential Hypertension
1 other identifier
interventional
234
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Jun 2020
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFebruary 24, 2020
February 1, 2020
2.3 years
February 9, 2020
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
average 24-h Systolic Blood Pressure (SBP)
change from baseline to 12 weeks after intervention
Secondary Outcomes (7)
average SBP and average Diastolic Blood Pressure (DBP)
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)
- +2 more secondary outcomes
Study Arms (3)
Tai Chi
EXPERIMENTAL3 sessions of Tai Chi per week for 12 weeks
Walking
ACTIVE COMPARATOR3 sessions of walking per week for 12 weeks
Waiting-list
NO INTERVENTIONInterventions
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.
Each session of walking will last 60 minutes, including a 10-minute warm-up, a 40-minute walking and a 10-minutes cool-down.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
Chengdu, Sichuan, 610075, China
Related Publications (1)
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.
PMID: 33413354DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Youping Liu, PhD
Chengdu University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2020
First Posted
February 12, 2020
Study Start
June 1, 2020
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
February 24, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share