Effects of MICT on Cardiopulmonary Function in Patients After TAVI

Cardiac Rehabilitation Clinical Trial

Official title:

Effects of Moderate Intensity Continuous Training (MICT) on Cardiopulmonary Function in Patients After Transcatheter Aortic Valve Implantation (TAVI): A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015712
• Other study ID #: N2021-08
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: Shenyang Northern Hospital
• Contact: Ya-Ling Han, PhD
• Phone: +862428897309
• Email: hanyaling[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Diseases
• Aortic Valve Disease
• Cardiac Rehabilitation

Intervention

Behavioral:
• moderate intensity continuous training
Moderate intensity continuous training was scheduled 3 times per week for 3 months. Every sessions included warm-up (<50% target intensity for 2 min then gradually increasing load 1-10 W/min up to 100% target intensity for 5-10 min), exercise phase (100% target intensity (heart rate at anaerobic threshold±5) starting with 20 min and gradually lengthening up to 45 min in the 1 month as well as 45 min in another 2 months), cool down with gradual reduction of load within 3 min. The target intensity will be determined by the heart rate at anaerobic threshold measured by cardiopulmonary exercise test (CPET). The intensity will be adjusted after implementation of CPET and will keep at a minimum intensity, gradually increasing to the maximum intensity every month. Moreover, patients will be instructed to complete 2 supervised sessions and 1 home-based session during the 1 month and then to continue 3 home-based session for a further 2 months.

Locations

Country	Name	City	State
China	Ya-Ling Han	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Han Yaling, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in peak oxygen uptake (peak VO2) after 3 months		3 months and 1 year
Secondary	6-min walk distance		3 months and 1 year
Secondary	the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12)		3 months and 1 year
Secondary	New York Heart Association class (NYHA)	The NYHA is measured by Classification of NYHA heart function	3 months and 1 year
Secondary	E/e'	it is measured by echocardiography	3 months and 1 year
Secondary	E/A	it is measured by echocardiography	3 months and 1 year
Secondary	left atrial volume index(LAVI)	it is measured by echocardiography	3 months and 1 year
Secondary	left ventricular ejection fraction(LV-EF)	it is measured by echocardiography	3 months and 1 year
Secondary	mean pressure gradient(PGmean)	it is measured by echocardiography	3 months and 1 year
Secondary	maximal pressure gradient (PGmax)	it is measured by echocardiography	3 months and 1 year
Secondary	maximal velocity(Vmax)	it is measured by echocardiography	3 months and 1 year
Secondary	valve orifice area	it is measured by echocardiography	3 months and 1 year
Secondary	N-terminal pro-brain natriuretic peptide (NT-proBNP)		3 months and 1 year
Secondary	C-reactive protein(CRP)		3 months and 1 year
Secondary	hemoglobin		3 months and 1 year
Secondary	cholesterol		3 months and 1 year
Secondary	triglyceride		3 months and 1 year
Secondary	high density lipoprotein (HDL)		3 months and 1 year
Secondary	low density lipoprotein (LDL)		3 months and 1 year
Secondary	Major adverse cardiovascular events	Major adverse cardiovascular events is a composite endpoint of death, stroke, revascularization, and myocardial infarction.	3 months and 1 year
Secondary	change in peak oxygen uptake (peak VO2) after 1 year		1 year