Effects of MICT on Cardiopulmonary Function in Patients After TAVI

NCT ID: NCT05015712

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2023-06-30

Brief 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.

Conditions

Valve Disease, Aortic; Cardiac Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

moderate intensity continuous training

Group Type: EXPERIMENTAL

moderate intensity continuous training

Intervention Type: BEHAVIORAL

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.

guideline control

Patients assigned to the guideline control just received 1-time advice on training according to guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Han Yaling, MD

OTHER

Sponsor Role: lead

Responsible Party

Han Yaling, MD

Director of Department of Cardiology, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ya-Ling Han, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China

Locations

Ya-Ling Han

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ya-Ling Han, PhD

Role: CONTACT

hanyaling@263.net

+862428897309

Facility Contacts

Yaling Han, PhD

Role: primary

hanyaling@263.net

02428897309

Other Identifiers

N2021-08

Identifier Type: -

Identifier Source: org_study_id