Effects of MICT on Cardiopulmonary Function in Patients After TAVI

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    66
  • sponsor
    Han Yaling, MD
Send
Updated on 25 July 2022
See if I qualify

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.

Details
Condition Valve Disease, Aortic, Cardiac Rehabilitation
Treatment Moderate Intensity Continuous Training
Clinical Study IdentifierNCT05015712
SponsorHan Yaling, MD
Last Modified on25 July 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note