Congenital Heart DefectsHIIT-GUCHNCT02632253
Effects of High-intensity Interval Training on Exercise Capacity in Patients With Grown-up Congenital Heart Disease
A study testing HIIT and MICE in people with Congenital Heart Defects, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Patients with congenital heart disease have long been discouraged from participating in physical exercise which has led to impaired exercise capacity in this population. Since low physical and cardiorespiratory fitness has been shown to be a predictor for hospitalization and mortality in grown-up patients with… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- HIIT and MICE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to Oct 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tetralogy of Fallot
- Double outlet right ventricle
- Transposition of the great arteries with atrial or arterial switch
- Treated or untreated pulmonary valvular or pulmonary artery stenosis
- Reduced right ventricular function after correction of atrial septal defect (ASD), atrio-ventricular septal defect (AVSD) or ventricular septal defect (VSD) (≤40%)
- Ebstein anomaly
- Patients with a systemic right ventricle like d-transposition of the great arteries (d-TGA) with previous atrial switch operation or cc-TGA
Who cannot join
- Inability to participate in a 3-month training program in Bern
- New York Heart Association class ≥ III
- Ventricular function ≤30% of either the systemic or the sub-pulmonary ventricle
- Moderate to severe LV outflow tract obstruction (valvular, subvalvular, due to asymmetric septum hypertrophy, or aortic coarctation) with mean gradient >30 mmHg by echo
- Severe RV outflow tract obstruction with peak gradient ≥60 mmHg by echo
- Moderate to severe pulmonary hypertension with mean pulmonary artery pressure≥40 mmHg
Show all 19Show fewer
- Resting saturation at ambient air of <90%
- Pacemaker or Implantable Cardioverter Defibrillator
- Contraindication to perform a CMR (cerebral clips, iron-containing body implants, medical pumps)
- Recent episode of ventricular tachycardia
- Permanent atrial fibrillation
- Unstable angina or recent myocardial infarction (<12 months)
- Recent cardiac operation <6 months
- Ascending aortic dilatation >45 mm in patients with bicuspid aortic valve or >50 mm in patients without bicuspid aortic valve
- Repaired coarctation with pseudoaneurysm in MR angiography
- No consent
- Any medical condition which would prevent a patient from performing high intensity training (e.g. cardiac thrombus formation, recent valve surgery (< 1 year), in general orthopedic, peripheral vascular, neurologic or other limitations)
- Inability to perform cardiopulmonary exercise testing
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Preventive Cardiology, Bern University Hospital
Bern, 3010
About this study
Official title: Effects of High-intensity Interval Training on Exercise Capacity in Patients With Grown-up Congenital Heart Disease (GUCH)
Patients with congenital heart disease have long been discouraged from participating in physical exercise which has led to impaired exercise capacity in this population. Since low physical and cardiorespiratory fitness has been shown to be a predictor for hospitalization and mortality in grown-up patients with congenital heart disease (GUCH), aerobic endurance training has been recommended recently to improve exercise capacity. The aim of this study is to compare two types of training, namely high-intensity interval training (HIIT) and moderate-intensity continuous exercise (MICE), with regard to improving exercise capacity without adverse effects on heart structure, function and rhythm in the setting of a 12-week outpatient cardiac rehabilitation (CR) program in GUCH with a remaining pathology involving the right and/or left ventricles. Primary endpoint will be change in exercise capacity (maximal oxygen consumption) over the 12-week CR. Secondary endpoints will be changes of the right or left ventricles as well as vascular function.
Patients with GUCH and reduced function of the right ventricle will be recruited and informed about the study within the first two weeks of CR. At the end of week 3 of the CR with supervised MICE, randomization to 9 weeks of twice weekly either HIIT or MICE takes place.
Read more
MICE training is performed at an intensity of 70-85% of maximum heart rate (HRmax) for 38 min. HIIT consists of four 4 min bouts of high-intensity exercise (90-95% of HRmax), interspersed by 3 min low-intensity intervals (50-60% of HRmax). All patients complete one additional endurance activity per week in their own time with a duration of 30-60 min at moderate intensity monitored by their smart phone.
Change in peak oxygen uptake as well as maximal exercise capacity at the end of an incremental cardiopulmonary exercise test will be assessed between week 3 and 12. Vascular function will be assessed at the same time. Volumes and function of the right and left ventricles will be measured by cardiac magnetic resonance imaging (CMR) upon inclusion into the study and at completion of the intervention. Furthermore, laboratory markers for heart failure as well as occurrence of irregular fast heart beats will be assessed.
Read the detailed description
Background
Adults with congenital heart disease have long been recommended to refrain from physical exercise. Therefore, they often have significant reduction in exercise capacity. Only recently, regular exercise has been shown to be safe and is nowadays recommended for patients with congenital heart disease. As a result, exercise based rehabilitation programs have been implemented in order to improve exercise capacity and avoid adverse effects associated with inactive lifestyle.
Several studies have shown that high-intensity interval training (HIIT) is more effective than moderate-intensity continuous exercise training (MICE) at improving functional capacity and quality of life in stable cardiac patients and can be performed safely. It has therefore emerged as a new and important exercise modality in cardiac rehabilitation centers all over Europe for stable cardiac patients with left ventricular (LV) dysfunction. However, its safety and efficacy has not yet been tested in adults with congenital heart disease and to date there are no studies who have evaluated whether short term peaks of pulmonary artery or systemic pressure during bouts of 4 min of high-intensity exercise negatively affects the subpulmonary or systemic ventricle in GUCH patients. The investigators hypothesized that the positive effects of HIIT on exercise capacity and vascular function found in patients with ischemic cardiomyopathy can be transferred to the population of GUCH patients, and that short-term bouts of high-intensity exercise will not negatively affect cardiac morphology and function.
Objective
To test the superiority of a 9-week high-intensity interval training (HIIT) over a standard rehabilitation training based on moderate-intensity continuous exercise (MICE) on exercise capacity in patients with grown-up congenital heart disease (GUCH) with a residual pathology involving the right and/or left ventricle (RV/LV).
Methods
Measurements will be performed before and after a 12 week intervention with either HIIT or MICE training. Patients will undergo cardiopulmonary exercise testing on a cycle ergometer to determine exercise capacity and VO2 peak. Cardiac magnetic resonance imaging will be performed for ventricular volumes, mass and function. Vascular function will be assessed by arterial stiffness measurement. Physical exercise, quality of life will be evaluated by questionnaires.
During the 4th and the 12th week of the rehabilitation training, heart rate variability will be measured in the morning following a training, and blood samples will be taken after a training session to analyse markers of myocardial stress (hs Troponin and N-terminal of the prohormone brain natriuretic peptide, NT pro-BNP). Compliance and acceptance of training will be assessed by questionnaires.
- Conditions
- Congenital Heart Defects
- Being tested
- HIIT, MICE
- Keywords
- exercise therapy, GUCH, ventricular ejection fraction, HIIT, MICE
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITProcedure or surgery
High-intensity interval training (HIIT) is performed on a cycle ergometer. It consists of a 10 min warm-up followed by 4 min intervals in Zone III (at 90-95% of peak heart rate), with each interval separated by 3 min of active pauses in zone I (at 50-70% of peak heart rate). The total duration of the HIIT training is 38 min. The HIIT group will perform two supervised HIIT trainings and one self monitored MICE training per week.
MICEOther
MICE is also performed on a cycle ergometer at an intensity of 70-75% of peak heart rate for 47 min (in order for the two training protocols to be isocaloric). The control group will perform two supervised and one self monitored MICE training per week.
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity continuous exercise | Active comparator | Patients perform two weekly supervised MICE session on a cycling ergometer per week plus one self monitored 30-60 min MICE training of choice at home.
MICE is performed on a cycle ergometer at an intensity of 70-75% of peak heart rate for 38 min (including a 5 min warm-up and 3 min cool-down). Receives: Other: MICE |
| High intensity interval training | Experimental | High-intensity interval training (HIIT) is performed on a cycle ergometer. It consists of a 10 min warm-up followed by 4 min intervals in Zone III (at 90-95% of peak heart rate), with each interval separated by 3 min of active pauses in zone I (at 50-70% of peak heart rate). The total duration of the HIIT training is 38 min.
Additionally patients perform one self monitored 30-60 min MICE training of choice per week at home. Receives: Procedure: HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2 peak) during maximal cardiopulmonary exercise test
Change in VO2 peak between week 1 and 12 is measured by cardiopulmonary exercise testing on a cycling ergometer.
Measured: week 1 to 12
Secondary outcomes (12)
VO2 peak during maximal cardiopulmonary exercise test
Change in VO2 peak between week 1 and 65 is measured by cardiopulmonary exercise testing on a cycling ergometer.
Measured: week 1 to 65
Ventricular Volumes by cardiac magnetic resonance imaging
Left and right ventricular volumes will be assessed by cardiac magnetic resonance imaging.
Measured: week 1 and 12
Ventricular function by cardiac magnetic resonance imaging (MR)
Left and right ventricular function will be assessed by cardiac magnetic resonance imaging (MR).
Measured: week 1 and 12
Vascular function by arterial stiffness measurement
Vascular function will be assessed by arterial stiffness measurement.
Measured: week 3, 12, and 65
Arrhythmias quantified and characterised by ECG
Arrhythmias will be assessed by 24-hour Holter ECG.
Measured: week 3, 12, and 65
N terminal pro b-type natriuretic peptide (NT- proBNP)
Blood samples are taken after an exercise training session.
Measured: week 0, 3, 12, and 65
hs Troponin
Blood samples are taken after an exercise training session.
Measured: week 3 and 12
Adherence to training
Training session adherence will be monitored and reported as percent of prescribed training volume.
Measured: week 1-12
Quality of life
Short form quality of life questionnaire (SF12)
Measured: week 1, 12, and 65
Quality of life for heart failure
Minnesota quality of life questionnaire
Measured: week 1, 12, and 65
Daily physical activity
International physical activity questionnaire
Measured: week 1, 12, and 65
Heart rate variability
Heart rate variability will be assessed during an orthostatic challenge test.
Measured: week 3, 12, and 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: Insufficient patients recruited due to a lack of GUCH patients enrolling in cardiac Rehabilitation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizerische Herzstiftung
- Responsible party
- Sponsor
- Investigators
- Christina Deluigi, MD, Principal investigator, Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne, Inselspital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632253
- Sponsor's protocol ID
- HIIT-GUCH
- Acronym
- HIIT-GUCH
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2015
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Interval Training on Exercise Capacity in Patients With Grown-up Congenital Heart Disease (GUCH)
- ClinicalTrials.gov ID
- NCT02632253
- Acronym / sponsor ID
- HIIT-GUCH / HIIT-GUCH
- Conditions
- Congenital Heart Defects
- Keywords
- exercise therapy, GUCH, ventricular ejection fraction, HIIT, MICE
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient patients recruited due to a lack of GUCH patients enrolling in cardiac Rehabilitation.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Schweizerische Herzstiftung
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 16 Dec 2015 (estimated)
- 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.
Patients with congenital heart disease have long been discouraged from participating in physical exercise which has led to impaired exercise capacity in this population. Since low physical and cardiorespiratory fitness has been shown to be a predictor for hospitalization and mortality in grown-up patients with congenital heart disease (GUCH), aerobic endurance training has been recommended recently to improve exercise capacity. The aim of this study is to compare two types of training, namely high-intensity interval training (HIIT) and moderate-intensity continuous exercise (MICE), with regard to improving exercise capacity without adverse effects on heart structure, function and rhythm in the setting of a 12-week outpatient cardiac rehabilitation (CR) program in GUCH with a remaining pathology involving the right and/or left ventricles. Primary endpoint will be change in exercise capacity (maximal oxygen consumption) over the 12-week CR. Secondary endpoints will be changes of the right or left ventricles as well as vascular function.
Patients with GUCH and reduced function of the right ventricle will be recruited and informed about the study within the first two weeks of CR. At the end of week 3 of the CR with supervised MICE, randomization to 9 weeks of twice weekly either HIIT or MICE takes place.
MICE training is performed at an intensity of 70-85% of maximum heart rate (HRmax) for 38 min. HIIT consists of four 4 min bouts of high-intensity exercise (90-95% of HRmax), interspersed by 3 min low-intensity intervals (50-60% of HRmax). All patients complete one additional endurance activity per week in their own time with a duration of 30-60 min at moderate intensity monitored by their smart phone.
Change in peak oxygen uptake as well as maximal exercise capacity at the end of an incremental cardiopulmonary exercise test will be assessed between week 3 and 12. Vascular function will be assessed at the same time. Volumes and function of the right and left ventricles will be measured by cardiac magnetic resonance imaging (CMR) upon inclusion into the study and at completion of the intervention. Furthermore, laboratory markers for heart failure as well as occurrence of irregular fast heart beats will be assessed.
Detailed description
Background
Adults with congenital heart disease have long been recommended to refrain from physical exercise. Therefore, they often have significant reduction in exercise capacity. Only recently, regular exercise has been shown to be safe and is nowadays recommended for patients with congenital heart disease. As a result, exercise based rehabilitation programs have been implemented in order to improve exercise capacity and avoid adverse effects associated with inactive lifestyle.
Several studies have shown that high-intensity interval training (HIIT) is more effective than moderate-intensity continuous exercise training (MICE) at improving functional capacity and quality of life in stable cardiac patients and can be performed safely. It has therefore emerged as a new and important exercise modality in cardiac rehabilitation centers all over Europe for stable cardiac patients with left ventricular (LV) dysfunction. However, its safety and efficacy has not yet been tested in adults with congenital heart disease and to date there are no studies who have evaluated whether short term peaks of pulmonary artery or systemic pressure during bouts of 4 min of high-intensity exercise negatively affects the subpulmonary or systemic ventricle in GUCH patients. The investigators hypothesized that the positive effects of HIIT on exercise capacity and vascular function found in patients with ischemic cardiomyopathy can be transferred to the population of GUCH patients, and that short-term bouts of high-intensity exercise will not negatively affect cardiac morphology and function.
Objective
To test the superiority of a 9-week high-intensity interval training (HIIT) over a standard rehabilitation training based on moderate-intensity continuous exercise (MICE) on exercise capacity in patients with grown-up congenital heart disease (GUCH) with a residual pathology involving the right and/or left ventricle (RV/LV).
Methods
Measurements will be performed before and after a 12 week intervention with either HIIT or MICE training. Patients will undergo cardiopulmonary exercise testing on a cycle ergometer to determine exercise capacity and VO2 peak. Cardiac magnetic resonance imaging will be performed for ventricular volumes, mass and function. Vascular function will be assessed by arterial stiffness measurement. Physical exercise, quality of life will be evaluated by questionnaires.
During the 4th and the 12th week of the rehabilitation training, heart rate variability will be measured in the morning following a training, and blood samples will be taken after a training session to analyse markers of myocardial stress (hs Troponin and N-terminal of the prohormone brain natriuretic peptide, NT pro-BNP). Compliance and acceptance of training will be assessed by questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity continuous exercise | Active comparator | Other: MICEPatients perform two weekly supervised MICE session on a cycling ergometer per week plus one self monitored 30-60 min MICE training of choice at home. MICE is performed on a cycle ergometer at an intensity of 70-75% of peak heart rate for 38 min (including a 5 min warm-up and 3 min cool-down). |
| High intensity interval training | Experimental | Procedure: HIITHigh-intensity interval training (HIIT) is performed on a cycle ergometer. It consists of a 10 min warm-up followed by 4 min intervals in Zone III (at 90-95% of peak heart rate), with each interval separated by 3 min of active pauses in zone I (at 50-70% of peak heart rate). The total duration of the HIIT training is 38 min. Additionally patients perform one self monitored 30-60 min MICE training of choice per week at home. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Tetralogy of Fallot
- Double outlet right ventricle
- Transposition of the great arteries with atrial or arterial switch
- Treated or untreated pulmonary valvular or pulmonary artery stenosis
- Reduced right ventricular function after correction of atrial septal defect (ASD), atrio-ventricular septal defect (AVSD) or ventricular septal defect (VSD) (≤40%)
Key exclusion criteria (19 listed)
- Inability to participate in a 3-month training program in Bern
- New York Heart Association class ≥ III
- Ventricular function ≤30% of either the systemic or the sub-pulmonary ventricle
- Moderate to severe LV outflow tract obstruction (valvular, subvalvular, due to asymmetric septum hypertrophy, or aortic coarctation) with mean gradient >30 mmHg by echo
- Severe RV outflow tract obstruction with peak gradient ≥60 mmHg by echo
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 |
|---|---|---|
| HIITHigh-intensity interval training (HIIT) is performed on a cycle ergometer. It consists of a 10 min warm-up followed by 4 min intervals in Zone III (at 90-95% of peak heart rate), with each interval separated by 3 min of active pauses in zone I (at 50-70% of peak heart rate). The total duration of the HIIT training is 38 min. The HIIT group will perform two supervised HIIT trainings and one self monitored MICE training per week. | Procedure or surgery | High intensity interval training |
| MICEMICE is also performed on a cycle ergometer at an intensity of 70-75% of peak heart rate for 47 min (in order for the two training protocols to be isocaloric). The control group will perform two supervised and one self monitored MICE training per week. | Other | Moderate intensity continuous exercise |
Primary outcome
Peak oxygen uptake (VO2 peak) during maximal cardiopulmonary exercise test
Time frame: week 1 to 12
Change in VO2 peak between week 1 and 12 is measured by cardiopulmonary exercise testing on a cycling ergometer.
12 secondary outcomes
VO2 peak during maximal cardiopulmonary exercise test
Time frame: week 1 to 65
Ventricular Volumes by cardiac magnetic resonance imaging
Time frame: week 1 and 12
Ventricular function by cardiac magnetic resonance imaging (MR)
Time frame: week 1 and 12
Vascular function by arterial stiffness measurement
Time frame: week 3, 12, and 65
Arrhythmias quantified and characterised by ECG
Time frame: week 3, 12, and 65
N terminal pro b-type natriuretic peptide (NT- proBNP)
Time frame: week 0, 3, 12, and 65
hs Troponin
Time frame: week 3 and 12
Adherence to training
Time frame: week 1-12
Quality of life
Time frame: week 1, 12, and 65
Quality of life for heart failure
Time frame: week 1, 12, and 65
Daily physical activity
Time frame: week 1, 12, and 65
Heart rate variability
Time frame: week 3, 12, and 65
Results and safety
The study was stopped early (reason given: Insufficient patients recruited due to a lack of GUCH patients enrolling in cardiac Rehabilitation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
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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.
Christina Deluigi, MD principal investigator
Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne, Inselspital, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and MICE in people with Congenital Heart Defects, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 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: stopped early, as of the sponsor's last update on 11 Dec 2020. 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 Switzerland. 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?
The study was stopped early (reason given: Insufficient patients recruited due to a lack of GUCH patients enrolling in cardiac Rehabilitation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (VO2 peak) during maximal cardiopulmonary exercise test (time frame: week 1 to 12). 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 11 Dec 2020.