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

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)

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:

  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 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
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.
Other Names:
  • Tai Ji Quan
Active Comparator: Walking
3 sessions of walking per week for 12 weeks
Behavioral: 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.
No Intervention: Waiting-list

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
change from baseline to 12 weeks after intervention

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
baseline, after intervention(12 week), after follow-up(24 week)
change of serum concentrations of Nitric Oxide
Time Frame: baseline, after intervention(12 week)
baseline, after intervention(12 week)
change of serum concentrations of endothelin
Time Frame: baseline, after intervention(12 week)
baseline, after intervention(12 week)
change of serum concentrations of thromboxane A2
Time Frame: baseline, after intervention(12 week)
baseline, after intervention(12 week)
change of serum concentrations of vascular endothelial growth factor
Time Frame: baseline, after intervention(12 week)
baseline, after intervention(12 week)
blood pressure measured at home with an upper arm electronic sphygmomanometer
Time Frame: baseline, after intervention(12 week), after follow-up(24 week)
baseline, after intervention(12 week), after follow-up(24 week)
Medical Outcomes Study 36-Item Short Form
Time Frame: 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.
baseline, after intervention(12 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

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.

General Publications

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

Keywords

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.

Clinical Trials on Hypertension

Clinical Trials on Tai Chi

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe