Effects of MICT on Cardiopulmonary Function in Patients After TAVI

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Rehabilitation; Valve Disease, Aortic
• Intervention / Treatment: Behavioral: moderate intensity continuous training

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Ling Han, PhD; Phone Number: +862428897309; Email: hanyaling@263.net

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • Ya-Ling Han
      • Contact: Yaling Han, PhD; Phone Number: 02428897309; Email: hanyaling@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: moderate intensity continuous training	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.
No Intervention: guideline control; Patients assigned to the guideline control just received 1-time advice on training according to guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in peak oxygen uptake (peak VO2) after 3 months	3 months and 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Han Yaling, MD
• Investigators: Principal Investigator: Ya-Ling Han, PhD, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: August 7, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: transcatheter aortic valve implantation; cardiac rehabilitation; cardiopulmonary function
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Valve Diseases; Aortic Valve Disease; Aortic Diseases
• Other Study ID Numbers: N2021-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No