the Effects of Different Exercise on Vascular Health

NCT ID: NCT06419751

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2025-06-30

Brief 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.

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.

Conditions

Mind-body Exercise; Vascular Health; M-health; Cardiac Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

Study participants were given training on dietary patterns, regular monitoring and follow-up through apps and wearable devices, and no forced exercise measures were performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Combined Exercise Group

Study 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

Group Type: ACTIVE_COMPARATOR

Regular exercise

Intervention Type: BEHAVIORAL

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)

Mind-body Exercise Group

Study 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.

Group Type: EXPERIMENTAL

Baduanjin

Intervention Type: BEHAVIORAL

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

Interventions

Regular exercise

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)

Intervention Type: BEHAVIORAL

Baduanjin

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age: ≥ 18 years old and < 60 years old;

2. cfPWV>10m/s;

3. Those who have 1 intelligent communication device and can use it proficiently (Android mobile phone is preferred);

4. People who have lived and/or worked relatively steadily in the past 6 months;

5. Signed informed consent.

Exclusion Criteria

1. Moderate to severe obesity (≥30kg/m^2);

2. Acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory respiratory diseases and acute cardiovascular and cerebrovascular diseases;

3. severe essential hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg) or poorly controlled essential hypertension;

4. Patients with secondary hypertension, acute hypertension, subacute hypertension and hypertensive encephalopathy;

5. Significant arrhythmia (atrial fibrillation, etc.);

6. Patients with atherosclerotic cardiovascular diseases, such as coronary heart disease, severe peripheral atherosclerotic diseases, etc.;

7. Type 1 diabetes, uncontrolled type 2 diabetes or other diseases affecting carbohydrate metabolism;

8. 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;

9. Cancer and other major comorbidities affecting arterial blood pressure;

10. Those who are unable to exercise due to fractures, joint instability and other physical diseases or diseases affecting the locomotor system;

11. Those who have involuntary physical movements due to mental illness, epilepsy or other diseases;

12. Those who have a pacemaker installed;

13. Pregnant/trying to conceive;

14. Patients with allergies, limb trauma or skin diseases who cannot cooperate with the completion of ABI and baPWV index examinations;

15. Those who have undergone or plan to have bariatric surgery in the next 12 months;

16. Those who have participated in other clinical studies in the past 3 months;

17. Refusal to sign informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xue Feng

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Central Contacts

Yifan Wu

Role: CONTACT

wuyifan1127@126.com

01088398069

Other Identifiers

2023-ZX067

Identifier Type: -

Identifier Source: org_study_id