Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tai Chi for Patients With Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 9, 2020
First Posted Date  ICMJE February 12, 2020
Last Update Posted Date February 24, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
average 24-h Systolic Blood Pressure (SBP) [ Time Frame: change from baseline to 12 weeks after intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
  • 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
  • change of serum concentrations of Nitric Oxide [ Time Frame: baseline, after intervention(12 week) ]
  • change of serum concentrations of endothelin [ Time Frame: baseline, after intervention(12 week) ]
  • change of serum concentrations of thromboxane A2 [ Time Frame: baseline, after intervention(12 week) ]
  • change of serum concentrations of vascular endothelial growth factor [ Time Frame: 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) ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tai Chi for Patients With Essential Hypertension
Official Title  ICMJE Tai Chi for Patients With Essential Hypertension: Study Protocol of an Open-label Single-center Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Tai Chi
    3 sessions of Tai Chi per week for 12 weeks
    Intervention: Behavioral: Tai Chi
  • Active Comparator: Walking
    3 sessions of walking per week for 12 weeks
    Intervention: Behavioral: Walking
  • No Intervention: Waiting-list
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2020)
234
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rongjiang Jin, PhD 13808072058 cdzyydxjrj@126.com
Contact: Juan Li, PhD 785939016@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04267471
Other Study ID Numbers  ICMJE 2019KL-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chengdu University of Traditional Chinese Medicine
Study Sponsor  ICMJE Chengdu University of Traditional Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Youping Liu, PhD Chengdu University of Traditional Chinese Medicine
PRS Account Chengdu University of Traditional Chinese Medicine
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP