Effects of MICT on Cardiopulmonary Function in Patients After TAVI

Han Yaling, MD

Status

Enrolling

Conditions

Cardiac Rehabilitation

Valve Disease, Aortic

Treatments

Behavioral: moderate intensity continuous training

Study type

Interventional

Funder types

Other

Identifiers

NCT05015712

N2021-08

Details and patient eligibility

About

Cardiac rehabilitation (CR), particularly regular exercise, can improve the cardiopulmonary function, exercise capacity, and quality of life for patients undergoing transcatheter aortic valve implantation (TAVI). Consequently, the patients after TAVI will be enrolled in our randomized controlled trial to demonstrate if the moderate-intensity continuous training (MICT) can improve the cardiopulmonary function compared with the control group after receiving treatment for 12 weeks. Moreover, we will provide new insights regarding whether cardiac systolic function or cardiac diastolic function is mainly improved after regular exercise for TAVI patients. As a result, the principal hypothesis of our study is that MICT will improve the cardiopulmonary function and can extremely affect the cardiac diastolic function of patients with TAVI after the implementation of exercise for 12 weeks.

Enrollment

66 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

TAVI after 1 month
able to start cardiac rehabilitation(CR) as judged by the study investigators
age >18 years old
6-min walk distance (6MWD) ≥100m
patients able to provide the informed consent before randomization

Exclusion criteria

exercise-limiting comorbidities such as primarily orthopedic, neurological conditions that would exclude the patients from participating in CR
linguistic deficits
patient unwilling or unable to provide written informed consent
patients with acute systemic diseases e.g. hyperthyroidism, electrolyte disturbances, uncontrolled diabetes, hemoglobin< 9 g/dL, uncontrolled asthma, severe obstructive pulmonary disease (forced expiratory volume in 1 second<50%), respiratory failure, and pulmonary embolism
echocardiographic signs of prosthesis dysfunction including valve orifice area of <1.2 cm2 plus a mean transaortic pressure gradient of ≥20 mmHg, or a velocity of ≥3 m/s, at least moderate paravalvular regurgitation, signs of ischemia, severe arrhythmias, or hemodynamic deterioration during the exercise test
decompensated heart failure (New York Heart Association (NYHA) class IV)
patients with irreversible atrial or ventricular arrhythmias or patients with severe atrioventricular block
bradycardia (heart rate<60bpm) or patients who need implantation of a pacemaker or implantable cardioverter defibrillators (ICD)
recent history of sudden cardiac death syndrome
suspected aortic dissection, pericarditis, hypertrophic obstructive cardiomyopathy and subacute bacterial endocarditis
untreated or uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure >110 mmHg) or hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <60mmHg)
cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism or other brain disease history
active or recent major bleeding or bleeding predisposition
coronary artery bypass grafting (CABG) within 3 months
renal insufficiency (serum creatinine >2.5 mg/dl)
planning to, or participation in another intervention study within 3 months
patients with exercise intolerance or poor exercise endurance
patients who are currently receiving systematic training
researchers think it is not suitable to participate in this study