- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04267471
Tai Chi for Patients With Essential Hypertension
February 21, 2020 updated by: Chengdu University of Traditional Chinese Medicine
Tai Chi for Patients With Essential Hypertension: Study Protocol of an Open-label Single-center Randomized Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
234
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rongjiang Jin, PhD
- Phone Number: 13808072058
- Email: cdzyydxjrj@126.com
Study Contact Backup
- Name: Juan Li, PhD
- Email: 785939016@qq.com
Study Locations
-
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Sichuan
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Chengdu, Sichuan, China, 610075
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tai Chi
3 sessions of Tai Chi per week for 12 weeks
|
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.
Other Names:
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Active Comparator: Walking
3 sessions of walking per week for 12 weeks
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Each session of walking will last 60 minutes, including a 10-minute warm-up, a 40-minute walking and a 10-minutes cool-down.
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No Intervention: Waiting-list
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
average 24-h Systolic Blood Pressure (SBP)
Time Frame: change from baseline to 12 weeks after intervention
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change from baseline to 12 weeks after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
average SBP and average Diastolic Blood Pressure (DBP)
Time Frame: baseline, after intervention(12 week), after follow-up(24 week)
|
average SBP and average DBP during the daytime and night-time
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baseline, after intervention(12 week), after follow-up(24 week)
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change of serum concentrations of Nitric Oxide
Time Frame: baseline, after intervention(12 week)
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baseline, after intervention(12 week)
|
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change of serum concentrations of endothelin
Time Frame: baseline, after intervention(12 week)
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baseline, after intervention(12 week)
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change of serum concentrations of thromboxane A2
Time Frame: baseline, after intervention(12 week)
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baseline, after intervention(12 week)
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change of serum concentrations of vascular endothelial growth factor
Time Frame: baseline, after intervention(12 week)
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baseline, after intervention(12 week)
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blood pressure measured at home with an upper arm electronic sphygmomanometer
Time Frame: baseline, after intervention(12 week), after follow-up(24 week)
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baseline, after intervention(12 week), after follow-up(24 week)
|
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Medical Outcomes Study 36-Item Short Form
Time Frame: baseline, after intervention(12 week)
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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.
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baseline, after intervention(12 week)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Youping Liu, PhD, Chengdu University of Traditional Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
February 9, 2020
First Submitted That Met QC Criteria
February 11, 2020
First Posted (Actual)
February 12, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019KL-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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Clinical Trials on Tai Chi
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Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalCompleted
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Taipei Veterans General Hospital, TaiwanNational Science Council, TaiwanCompleted
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Chang Gung Memorial HospitalCompleted
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Texas Tech University Health Sciences CenterActive, not recruiting
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Massachusetts General HospitalUnknown
-
Chen Li TienCompletedExercise TrainingTaiwan
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Tufts Medical CenterMassachusetts General HospitalCompletedChronic Pain | FibromyalgiaUnited States
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Tufts Medical CenterNational Center for Complementary and Integrative Health (NCCIH)Completed
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Edward Via Virginia College of Osteopathic MedicineNational Center for Complementary and Integrative Health (NCCIH); The University...RecruitingKnee OsteoarthritisUnited States