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High intensity interval training in patients with tetralogy of Fallot

High intensity interval training in patients with tetralogy of Fallot - TOFHIIT study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51183
Enrollment
44
Registered
2021-08-24
Start date
2022-01-14
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetralogy of Fallot

Interventions

12 weeks of online based interval training 3 times a week.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
12 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Surgical repair for Tetralogy of Fallot through transatrial-transpulmonary repair, below the age of 2 years. • Between 12 and 30 years of age • Being followed in ACAHA (academisch centrum voor aangeboren hartafwijkingen, Erasmus MC, Sophia Childers hospital, Radboud UMC, Amalia children*s hospital) • Does not comply with the *Nederlandse Norm Gezond Bewegen*

Exclusion criteria

Exclusion criteria: • Inability to exercise or a contraindication for exercise such as long QT syndrome • Ventricular outflow obstruction (gradient of over 36 mmHg) • Developmental delay • Standard contra-indications for MRI • Use of beta blockers • Documented cardiac arrhytmias

Design outcomes

Primary

MeasureTime frame
Decrease in pulse wave velocity in the aorta and pulmonary artery measured by MRI.

Secondary

MeasureTime frame
1. Exercise capacity measured with a cardiopulmonary exercise test (VO2 peak and Wattage peak) 2. Other measures of cardiac function: • MRI: Left and right end diastolic, end systolic, stroke volume and ejection fraction. Changes in wave reflection patterns in the pulmonary artery as measure by Schafer et al. (1) Mass and thickness of the ventricle wall. Flow variables in the aorta and pulmonary arteries not covered by our main endpoint including 4D flow analysis. Patient data can be compared to existing local reference data of healthy volunteers • Echo: Two-dimensional echocardiography An echocardiogram will be made by a trained sonographer or pediatric cardiologist. Oon a commercially available ultrasound platform. Echocardiography Wwill be used to assess the following variables of cardiac size and function: Global ventricular function (ventricular volumes, ejection fraction) Regional ventricular function: right and/or left ventricular or single ventricular global and regional strain / strain rate. Diastolic ventricular function: peak velocity of the antegrade systolic wave, early diastolic wave and the peak velocity of the late diastolic retrograde wave will be measured of the pulmonary venous flow E and A velocities, and E - A ratio will be assessed of systemic atrioventricular flows. Semiquantitative assessment of semilunar and atriovernricular valve regurgitation. Patient data can be compared to existing local reference data of healthy volunteers. 3. Changes in body fat percentage, height and weight and their derivates BMI and BSA 4. Questionnaires of QoL • Will be assed using CHQ-PF28, CHQ-CF45, SF36 (for persons above 18) and SQUASH)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)