Effects of MICT on Cardiopulmonary Function in Patients After TAVI

July 12, 2022 updated by: Han Yaling, MD

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Recruiting
        • Ya-Ling Han
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
change in peak oxygen uptake (peak VO2) after 3 months
Time Frame: 3 months and 1 year
3 months and 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6-min walk distance
Time Frame: 3 months and 1 year
3 months and 1 year
the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12)
Time Frame: 3 months and 1 year
3 months and 1 year
New York Heart Association class (NYHA)
Time Frame: 3 months and 1 year
The NYHA is measured by Classification of NYHA heart function
3 months and 1 year
E/e'
Time Frame: 3 months and 1 year
it is measured by echocardiography
3 months and 1 year
E/A
Time Frame: 3 months and 1 year
it is measured by echocardiography
3 months and 1 year
left atrial volume index(LAVI)
Time Frame: 3 months and 1 year
it is measured by echocardiography
3 months and 1 year
left ventricular ejection fraction(LV-EF)
Time Frame: 3 months and 1 year
it is measured by echocardiography
3 months and 1 year
mean pressure gradient(PGmean)
Time Frame: 3 months and 1 year
it is measured by echocardiography
3 months and 1 year
maximal pressure gradient (PGmax)
Time Frame: 3 months and 1 year
it is measured by echocardiography
3 months and 1 year
maximal velocity(Vmax)
Time Frame: 3 months and 1 year
it is measured by echocardiography
3 months and 1 year
valve orifice area
Time Frame: 3 months and 1 year
it is measured by echocardiography
3 months and 1 year
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame: 3 months and 1 year
3 months and 1 year
C-reactive protein(CRP)
Time Frame: 3 months and 1 year
3 months and 1 year
hemoglobin
Time Frame: 3 months and 1 year
3 months and 1 year
cholesterol
Time Frame: 3 months and 1 year
3 months and 1 year
triglyceride
Time Frame: 3 months and 1 year
3 months and 1 year
high density lipoprotein (HDL)
Time Frame: 3 months and 1 year
3 months and 1 year
low density lipoprotein (LDL)
Time Frame: 3 months and 1 year
3 months and 1 year
Major adverse cardiovascular events
Time Frame: 3 months and 1 year
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
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Han Yaling, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ya-Ling Han, PhD, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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