HypertensionNCT04267471
Tai Chi for Patients With Essential Hypertension
A study testing Tai Chi and Walking in people with Hypertension, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Tai Chi and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- Jun 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Juan Li, PhD contact
China1 site
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
Chengdu, Sichuan, 610075
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Tai Chi, Walking
- Keywords
- Tai Chi, Hypertension, Randomized Controlled Trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Also called Tai Ji Quan
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.
WalkingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | 3 sessions of Tai Chi per week for 12 weeks Receives: Behavioral: Tai Chi |
| Walking | Active comparator | 3 sessions of walking per week for 12 weeks Receives: Behavioral: Walking |
| Waiting-list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
average 24-h Systolic Blood Pressure (SBP)
Measured: change from baseline to 12 weeks after intervention
Secondary outcomes (7)
average SBP and average Diastolic Blood Pressure (DBP)
average SBP and average DBP during the daytime and night-time
Measured: baseline, after intervention(12 week), after follow-up(24 week)
change of serum concentrations of Nitric Oxide
Measured: baseline, after intervention(12 week)
change of serum concentrations of endothelin
Measured: baseline, after intervention(12 week)
change of serum concentrations of thromboxane A2
Measured: baseline, after intervention(12 week)
change of serum concentrations of vascular endothelial growth factor
Measured: baseline, after intervention(12 week)
blood pressure measured at home with an upper arm electronic sphygmomanometer
Measured: baseline, after intervention(12 week), after follow-up(24 week)
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.
Measured: baseline, after intervention(12 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study startJun 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youping Liu, PhD, Study chair, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267471
- Sponsor's protocol ID
- 2019KL-001
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33413354
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi for Patients With Essential Hypertension: Study Protocol of an Open-label Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04267471
- Acronym / sponsor ID
- 2019KL-001
- Conditions
- Hypertension
- Keywords
- Tai Chi, Hypertension, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai Chi3 sessions of Tai Chi per week for 12 weeks |
| Walking | Active comparator | Behavioral: Walking3 sessions of walking per week for 12 weeks |
| Waiting-list | No intervention | – |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiAlso: Tai Ji QuanTai 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. | Behavioural | Tai Chi |
| WalkingEach session of walking will last 60 minutes, including a 10-minute warm-up, a 40-minute walking and a 10-minutes cool-down. | Behavioural | Walking |
Primary outcome
average 24-h Systolic Blood Pressure (SBP)
Time frame: change from baseline to 12 weeks after intervention
7 secondary outcomes
average SBP and average Diastolic Blood Pressure (DBP)
Time frame: baseline, after intervention(12 week), after follow-up(24 week)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Derived from this study: PubMed 33413354Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Li, PhD contact
Youping Liu, PhD study chair
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Walking in people with Hypertension, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongjiang Jin, PhD (13808072058, cdzyydxjrj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average 24-h Systolic Blood Pressure (SBP) (time frame: change from baseline to 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.