Effects of High-intensity Interval Training on Exercise Capacity in Patients With Grown-up Congenital Heart Disease

NCT02632253 | Terminated DMC

• 1 other identifier: HIIT-GUCH
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Congenital Heart Defects

Keywords

exercise therapy; GUCH; ventricular ejection fraction; HIIT; MICE

Outcome Measures

Primary Outcomes (1)

• 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.

  week 1 to 12

Secondary Outcomes (12)

• VO2 peak during maximal cardiopulmonary exercise test

  week 1 to 65

• Ventricular Volumes by cardiac magnetic resonance imaging

  week 1 and 12

• Ventricular function by cardiac magnetic resonance imaging (MR)

  week 1 and 12

• Vascular function by arterial stiffness measurement

  week 3, 12, and 65

• Arrhythmias quantified and characterised by ECG

  week 3, 12, and 65

Other Outcomes (1)

• Heart rate variability

  week 3 and 12

Study Arms (2)

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).

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.

Procedure: HIIT

Interventions

HIIT PROCEDURE

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.

High intensity interval training

MICE OTHER

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.

Moderate intensity continuous exercise

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Schweizerische Herzstiftung: collaborator

Study Sites (1)

Department of Preventive Cardiology, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christina Deluigi, MD

  Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne, Inselspital, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 16, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

CH (1)