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Tai Chi for Patients With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT04267471
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Tai Chi Behavioral: Walking Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tai Chi for Patients With Essential Hypertension: Study Protocol of an Open-label Single-center Randomized Controlled Trial
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. average 24-h Systolic Blood Pressure (SBP) [ Time Frame: change from baseline to 12 weeks after intervention ]

Secondary Outcome Measures :
  1. 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

  2. change of serum concentrations of Nitric Oxide [ Time Frame: baseline, after intervention(12 week) ]
  3. change of serum concentrations of endothelin [ Time Frame: baseline, after intervention(12 week) ]
  4. change of serum concentrations of thromboxane A2 [ Time Frame: baseline, after intervention(12 week) ]
  5. change of serum concentrations of vascular endothelial growth factor [ Time Frame: baseline, after intervention(12 week) ]
  6. blood pressure measured at home with an upper arm electronic sphygmomanometer [ Time Frame: baseline, after intervention(12 week), after follow-up(24 week) ]
  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267471


Contacts
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Contact: Rongjiang Jin, PhD 13808072058 cdzyydxjrj@126.com
Contact: Juan Li, PhD 785939016@qq.com

Locations
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China, Sichuan
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
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Study Chair: Youping Liu, PhD Chengdu University of Traditional Chinese Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04267471    
Other Study ID Numbers: 2019KL-001
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chengdu University of Traditional Chinese Medicine:
Tai Chi
Hypertension
Randomized Controlled Trial
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases