the Effects of Different Exercise on Vascular Health

Keywords

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

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 262 studies on the registry; 138 are open to participants now.

Study arms

• No intervention
  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.

• Active comparator
  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

  Behavioral: Regular exercise

• Experimental
  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.

  Behavioral: Baduanjin

Interventions

• BehavioralRegular 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)

• BehavioralBaduanjin

  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

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.

   Time frame: baseline,3months,6months,9 months

Secondary outcomes

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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: baseline,3months,6months,9 months