the Effects of Different Exercise on Vascular Health

NCT06419751 | Not Yet Recruiting

• 1 other identifier: 2023-ZX067
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

m-health; mind-body exercise; cardiac rehabilitation; arterial stiffness

Outcome Measures

Primary Outcomes (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.

  baseline,3months,6months,9 months

Secondary Outcomes (7)

• Brachi-ankle pulse wave velocity（baPWV）

  baseline,3months,6months,9 months

• blood pressure

  baseline,3months,6months,9 months

• body weight

  baseline,3months,6months,9 months

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

  baseline,3months,6months,9 months

• Physical fitness

  baseline,3months,6months,9 months

Study Arms (3)

Control

NO INTERVENTION

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.

Combined Exercise Group

ACTIVE COMPARATOR

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

Behavioral: Regular exercise

Mind-body Exercise Group

EXPERIMENTAL

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.

Behavioral: Baduanjin

Interventions

Regular exercise 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)

Combined Exercise Group

Baduanjin 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

Mind-body Exercise Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.;
• 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;

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Officials

• Xue Feng

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Wu

CONTACT

01088398069; wuyifan1127@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05