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Mind-body ExerciseNCT06419751

the Effects of Different Exercise on Vascular Health

A study testing Regular exercise and Baduanjin in people with Mind-body Exercise and Vascular Health, run by China National Center for Cardiovascular Diseases.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To explore the effect of smart app and wearable-based lifestyle intervention management on vascular health, comparing different exercise with the improvement of vascular arterial stiffness. The accuracy and consistency evaluation of smart wearable devices in screening for vascular health risks were also discussed. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Mind-body Exercise, Vascular Health, M-health
What is being tested?
Regular exercise and Baduanjin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
No sites listed yet
Study dates
30 May 2024to 30 Jun 2025
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age: ≥ 18 years old and < 60 years old;
  • cfPWV>10m/s;
  • Those who have 1 intelligent communication device and can use it proficiently (Android mobile phone is preferred);
  • People who have lived and/or worked relatively steadily in the past 6 months;
  • Signed informed consent.

Who cannot join

  • Moderate to severe obesity (≥30kg/m^2);
  • Acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory respiratory diseases and acute cardiovascular and cerebrovascular diseases;
  • severe essential hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg) or poorly controlled essential hypertension;
  • Patients with secondary hypertension, acute hypertension, subacute hypertension and hypertensive encephalopathy;
  • Significant arrhythmia (atrial fibrillation, etc.);
  • Patients with atherosclerotic cardiovascular diseases, such as coronary heart disease, severe peripheral atherosclerotic diseases, etc.;
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  • Type 1 diabetes, uncontrolled type 2 diabetes or other diseases affecting carbohydrate metabolism;
  • Severe stenosis of the carotid and/or femoral arteries (resulting in significant abnormalities in the blood flow spectrum); Those who have anatomical abnormalities of the aorta and major branches and cannot complete PWV detection;
  • Cancer and other major comorbidities affecting arterial blood pressure;
  • Those who are unable to exercise due to fractures, joint instability and other physical diseases or diseases affecting the locomotor system;
  • Those who have involuntary physical movements due to mental illness, epilepsy or other diseases;
  • Those who have a pacemaker installed;
  • Pregnant/trying to conceive;
  • Patients with allergies, limb trauma or skin diseases who cannot cooperate with the completion of ABI and baPWV index examinations;
  • Those who have undergone or plan to have bariatric surgery in the next 12 months;
  • Those who have participated in other clinical studies in the past 3 months;
  • Refusal to sign informed consent.

Trial locations and contacts

No sites are listed yet.

Yifan Wu contact

01088398069

wuyifan1127@126.com

About this study

Official title: Research on the Effect of Lifestyle Intervention Combined With Wearable Devices Based on Different Exercise on Vascular Health

To explore the effect of smart app and wearable-based lifestyle intervention management on vascular health, comparing different exercise with the improvement of vascular arterial stiffness. The accuracy and consistency evaluation of smart wearable devices in screening for vascular health risks were also discussed.

Read the detailed description

This study intends to carry out a randomized controlled trial to dynamically monitor a variety of cardiovascular parameters in people with high risk of vascular health, using wearable devices and artificial intelligence-assisted health management platform, and provide intelligent lifestyle intervention programs with different exercise.By observing the improvement of vascular health in the study population, the management effect of intelligent lifestyle intervention on high-risk groups of vascular health was evaluated. It is expected that through comprehensive lifestyle intervention based on smart wearable devices, early prevention and control of arteriosclerosis can be achieved, the level of hospital health management will be improved, and more physical health and health economic benefits will be obtained.

Being tested
Regular exercise, Baduanjin
Keywords
m-health, mind-body exercise, cardiac rehabilitation, arterial stiffness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular exerciseBehavioural

    Based on the study participant's status and exercise assessment, the investigators prescribe moderate-intensity aerobic exercise combined with resistance exercise. Before each exercise, preparatory activities (10min), 20-30min moderate-intensity aerobic exercise, finishing activities (10min) at the end, 5 days/week, for 12 weeks, and at the same time, choose non-consecutive 3 days of resistance training in 5 aerobic training sessions to increase resistance training (choose 1~2 muscle groups each time, 4~5 movements, repeat each action 8~12 times, repeat 2~3 sets)

  • BaduanjinBehavioural

    A professional therapist instructed the participants to learn and train Baduanjin before the intervention, and a standardized Baduanjin exercise program included eight postures, each training time was about 50 minutes (including 10 min of warm-up, 2 times of Baduanjin, and 10 min of relaxation), 5 days/week, a total of 12 weeks

Study groups in NCT06419751
Study groupRoleWhat they receive
ControlNo interventionStudy participants were given training on dietary patterns, regular monitoring and follow-up through apps and wearable devices, and no forced exercise measures were performed.
Combined Exercise GroupActive comparatorStudy participants were given training on dietary patterns, regular monitoring and follow-up through apps and wearable devices.Based on the status of the study participants and the results of the cardiopulmonary exercise test, the investigators prescribe moderate-intensity aerobic exercise combined with resistance exercise
Receives: Behavioral: Regular exercise
Mind-body Exercise GroupExperimentalStudy participants were given training on dietary patterns, regular monitoring and follow-up through apps and wearable devices.A standardized Baduanjin exercise program consists of eight postures, each training time is about 30 minutes (including 10 min warm-up, 2 times of Baduanjin, and 10 min of relaxation), 5 days/week, a total of 12 weeks.
Receives: Behavioral: Baduanjin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical femoral pulse wave velocity（cfPWV）

    The cardio-cerebrovascular and aortic function detector (Campura, France, model: Complior Analyse) was used to measure cfPWV, and the study participants were in a supine position, lying flat on the pillow, with their palms up on their sides of the body, so that their whole body was relaxed and rested for about 3 minutes. PWV can reflect arterial stiffness, and the European Society of Cardiology recommends cfPWV >10 m/s as the definitive threshold for assessing arterial functional changes in hypertension.We monitored cfPWV at baseline,3,6,9 months of the study.

    Measured: baseline,3months,6months,9 months

Secondary outcomes (7)

  1. Brachi-ankle pulse wave velocity（baPWV）

    The blood pressure of the limbs is measured with the Omron arteriosclerosis detector, and the pulse conduction velocity (baPWV) and ankle-brachial index (ABI) are calculated to automatically evaluate the degree of arteriosclerosis and blood vessel blockage. Positive criteria for baPWV: ≥1400 cm/s or baPWV% ≥ 19% is arteriosclerosis. Lower extremity vascular occlusion (ABI positive criteria): ≤0.9 for peripheral arterial stenosis and ≤0.5 for possible peripheral arterial occlusion.We monitored baPWV at baseline,3,6,9 months of the study.

    Measured: baseline,3months,6months,9 months

  2. blood pressure

    Blood pressure indicator: systolic blood pressure and diastolic blood pressure.We monitored blood pressure at baseline,3,6,9 months of the study.

    Measured: baseline,3months,6months,9 months

  3. body weight

    Using bioelectrical impedance analysis to monitor body weight,weight and height will be combined to report BMI in kg/m^2.We monitored body composition at baseline,3,6,9 months of the study.

    Measured: baseline,3months,6months,9 months

  4. Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L)

    Lipid metabolism indicators: total cholesterol , triglyceride , high density lipoprotein cholesterol, low density lipoprotein cholesterol.We monitored lipid metabolism parameters at baseline,3,6,9 months of the study.

    Measured: baseline,3months,6months,9 months

  5. Physical fitness

    The measurement of muscle strength, balance and flexibility is completed by the rehabilitation therapist, mainly including: (1) upper limb muscle strength test (dumbbell arm curl test); (2) Lower limb muscle strength test (chair standing and sitting test); (3) balance ability test; (4) Lower limb flexibility assessment (chair sitting body forward bending test); (5) Upper limb flexibility assessment (two-hand dorsum extension test). Participants were observed for changes at baseline, 3,6,9 months.

    Measured: baseline,3months,6months,9 months

  6. Vascular Health Index

    The PWV was analyzed by the smart watch through ECG (electrocardiogram) and PPG (photoplethysmography) sensors to evaluate the degree of vascular elasticity, and the vascular health index and evaluation were obtained, and the results were divided into low-risk, medium-risk, and high-risk.

    Measured: baseline,3months,6months,9 months

  7. Application adherence

    Study participants who received remote lifestyle interventions through the app, completed all exercise training content per week, or clocked in ≥ exercise 3 times were considered to have good compliance; Those who check in < exercise 3 times a week are considered to have poor compliance.

    Measured: baseline,3months,6months,9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2024
  2. Study start30 May 2024 (estimated)
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06419751
Sponsor's protocol ID
2023-ZX067
Status last verified
May 2024
First submitted
14 May 2024
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Regular exercise and Baduanjin in people with Mind-body Exercise and Vascular Health, run by China National Center for Cardiovascular Diseases.

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 5 inclusion and 17 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Yifan Wu (01088398069, wuyifan1127@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical femoral pulse wave velocity（cfPWV） (time frame: baseline,3months,6months,9 months). 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 NCT06419751.

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 17 May 2024.

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