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Tai Chi for Patients With Essential Hypertension

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tai Chi
Walking
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Tai Chi, Hypertension, Randomized Controlled Trial

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Tai Chi

Walking

Waiting-list

Arm Description

3 sessions of Tai Chi per week for 12 weeks

3 sessions of walking per week for 12 weeks

Outcomes

Primary Outcome Measures

average 24-h Systolic Blood Pressure (SBP)

Secondary Outcome Measures

average SBP and average Diastolic Blood Pressure (DBP)
average SBP and average DBP during the daytime and night-time
change of serum concentrations of Nitric Oxide
change of serum concentrations of endothelin
change of serum concentrations of thromboxane A2
change of serum concentrations of vascular endothelial growth factor
blood pressure measured at home with an upper arm electronic sphygmomanometer
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.

Full Information

First Posted
February 9, 2020
Last Updated
February 21, 2020
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04267471
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Tai Chi, Hypertension, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
3 sessions of Tai Chi per week for 12 weeks
Arm Title
Walking
Arm Type
Active Comparator
Arm Description
3 sessions of walking per week for 12 weeks
Arm Title
Waiting-list
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Other Intervention Name(s)
Tai Ji Quan
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walking
Intervention Description
Each session of walking will last 60 minutes, including a 10-minute warm-up, a 40-minute walking and a 10-minutes cool-down.
Primary Outcome Measure Information:
Title
average 24-h Systolic Blood Pressure (SBP)
Time Frame
change from baseline to 12 weeks after intervention
Secondary Outcome Measure Information:
Title
average SBP and average Diastolic Blood Pressure (DBP)
Description
average SBP and average DBP during the daytime and night-time
Time Frame
baseline, after intervention(12 week), after follow-up(24 week)
Title
change of serum concentrations of Nitric Oxide
Time Frame
baseline, after intervention(12 week)
Title
change of serum concentrations of endothelin
Time Frame
baseline, after intervention(12 week)
Title
change of serum concentrations of thromboxane A2
Time Frame
baseline, after intervention(12 week)
Title
change of serum concentrations of vascular endothelial growth factor
Time Frame
baseline, after intervention(12 week)
Title
blood pressure measured at home with an upper arm electronic sphygmomanometer
Time Frame
baseline, after intervention(12 week), after follow-up(24 week)
Title
Medical Outcomes Study 36-Item Short Form
Description
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.
Time Frame
baseline, after intervention(12 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongjiang Jin, PhD
Phone
13808072058
Email
cdzyydxjrj@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Li, PhD
Email
785939016@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youping Liu, PhD
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33413354
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.
Results Reference
derived

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Tai Chi for Patients With Essential Hypertension

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