Valve Disease, AorticNCT05015712
Effects of MICT on Cardiopulmonary Function in Patients After TAVI
A study testing moderate intensity continuous training in people with Valve Disease, Aortic and Cardiac Rehabilitation, run by Han Yaling, MD at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valve Disease, Aortic, Cardiac Rehabilitation
- What is being tested?
- moderate intensity continuous training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ya-Ling Han
Shenyang, Liaoning, 110016
Yaling Han, PhD, 02428897309, hanyaling@263.net
About this study
Official title: 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.
- Conditions
- Valve Disease, Aortic, Cardiac Rehabilitation
- Being tested
- moderate intensity continuous training
- Keywords
- transcatheter aortic valve implantation, cardiac rehabilitation, cardiopulmonary function
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate intensity continuous trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| moderate intensity continuous training | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in peak oxygen uptake (peak VO2) after 3 months
Measured: 3 months and 1 year
Secondary outcomes (20)
6-min walk distance
Measured: 3 months and 1 year
the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12)
Measured: 3 months and 1 year
New York Heart Association class (NYHA)
The NYHA is measured by Classification of NYHA heart function
Measured: 3 months and 1 year
E/e'
it is measured by echocardiography
Measured: 3 months and 1 year
E/A
it is measured by echocardiography
Measured: 3 months and 1 year
left atrial volume index(LAVI)
it is measured by echocardiography
Measured: 3 months and 1 year
left ventricular ejection fraction(LV-EF)
it is measured by echocardiography
Measured: 3 months and 1 year
mean pressure gradient(PGmean)
it is measured by echocardiography
Measured: 3 months and 1 year
maximal pressure gradient (PGmax)
it is measured by echocardiography
Measured: 3 months and 1 year
maximal velocity(Vmax)
it is measured by echocardiography
Measured: 3 months and 1 year
valve orifice area
it is measured by echocardiography
Measured: 3 months and 1 year
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Measured: 3 months and 1 year
C-reactive protein(CRP)
Measured: 3 months and 1 year
hemoglobin
Measured: 3 months and 1 year
cholesterol
Measured: 3 months and 1 year
triglyceride
Measured: 3 months and 1 year
high density lipoprotein (HDL)
Measured: 3 months and 1 year
low density lipoprotein (LDL)
Measured: 3 months and 1 year
Major adverse cardiovascular events
Major adverse cardiovascular events is a composite endpoint of death, stroke, revascularization, and myocardial infarction.
Measured: 3 months and 1 year
change in peak oxygen uptake (peak VO2) after 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start20 Aug 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Disease, AorticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Yaling, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Yaling, MD, Shenyang Northern Hospital
- Investigators
- Ya-Ling Han, PhD, Principal investigator, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015712
- Sponsor's protocol ID
- N2021-08
- Status last verified
- Jul 2022
- First submitted
- 7 Aug 2021
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate Intensity Continuous Training (MICT) on Cardiopulmonary Function in Patients After Transcatheter Aortic Valve Implantation (TAVI): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05015712
- Acronym / sponsor ID
- N2021-08
- Conditions
- Valve Disease, Aortic, Cardiac Rehabilitation
- Keywords
- transcatheter aortic valve implantation, cardiac rehabilitation, cardiopulmonary function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Han Yaling, MDUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moderate intensity continuous trainingModerate 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. | Behavioural | moderate intensity continuous training |
Primary outcome
change in peak oxygen uptake (peak VO2) after 3 months
Time frame: 3 months and 1 year
20 secondary outcomes
6-min walk distance
Time frame: 3 months and 1 year
the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12)
Time frame: 3 months and 1 year
New York Heart Association class (NYHA)
Time frame: 3 months and 1 year
E/e'
Time frame: 3 months and 1 year
E/A
Time frame: 3 months and 1 year
left atrial volume index(LAVI)
Time frame: 3 months and 1 year
left ventricular ejection fraction(LV-EF)
Time frame: 3 months and 1 year
mean pressure gradient(PGmean)
Time frame: 3 months and 1 year
maximal pressure gradient (PGmax)
Time frame: 3 months and 1 year
maximal velocity(Vmax)
Time frame: 3 months and 1 year
valve orifice area
Time frame: 3 months and 1 year
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: 3 months and 1 year
C-reactive protein(CRP)
Time frame: 3 months and 1 year
hemoglobin
Time frame: 3 months and 1 year
cholesterol
Time frame: 3 months and 1 year
triglyceride
Time frame: 3 months and 1 year
high density lipoprotein (HDL)
Time frame: 3 months and 1 year
low density lipoprotein (LDL)
Time frame: 3 months and 1 year
Major adverse cardiovascular events
Time frame: 3 months and 1 year
change in peak oxygen uptake (peak VO2) after 1 year
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Ling Han, PhD principal investigator
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate intensity continuous training in people with Valve Disease, Aortic and Cardiac Rehabilitation, run by Han Yaling, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Ling Han, PhD (+862428897309, hanyaling@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in peak oxygen uptake (peak VO2) after 3 months (time frame: 3 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.