Effects of MICT on Cardiopulmonary Function in Patients After TAVI

NCT05015712 | Unknown

• 1 other identifier: N2021-08
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

transcatheter aortic valve implantation; cardiac rehabilitation; cardiopulmonary function

Outcome Measures

Primary Outcomes (1)

• change in peak oxygen uptake (peak VO2) after 3 months

  3 months and 1 year

Secondary Outcomes (20)

• 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)

  3 months and 1 year

• E/e'

  3 months and 1 year

• E/A

  3 months and 1 year

Study Arms (2)

moderate intensity continuous training

EXPERIMENTAL

Behavioral: moderate intensity continuous training

guideline control

NO INTERVENTION

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

Interventions

moderate intensity continuous training 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.

moderate intensity continuous training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Han Yaling, MD: lead

Study Sites (1)

Ya-Ling Han

Shenyang, Liaoning, 110016, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ya-Ling Han, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Ling Han, PhD

CONTACT

+862428897309; hanyaling@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Cardiology, Principal Investigator

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 20, 2021
• Study Start: August 20, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

CN (1)