Exercise capacity in Tetralogy of Fallot: heart, lungs or muscles?

Exercise capacity in Tetralogy of Fallot: heart, lungs or muscles? - Exercise capacity in Tetralogy of Fallot

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42647

Enrollment

150

Registered

2015-12-02

Start date

2016-03-22

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

congenital heart defect Tetralogy of Fallot

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Children and adolescents corrected for Tetralogy of Fallot, 21 years old or younger (minimum age of 8) followed routinely in the University Medical Centre Groningen. 2) Children and adolescents with a corrected Coarctatio aortae, 21 years old or younger (minimum age of 8) followed routinely in the University Medical Centre Groningen. 3) Height > 120 cm in order to be able to fit on the bicycle. 4) Written informed consent.

Exclusion criteria

Exclusion criteria: For all participants - Patients with mental retardation. - Patients who have contra-indications for exercise testing. - Patients known with a muscular dystrophy (such as Becker or Duchenne). - Patients with instable lung disease. - Patients with previous surgery for scoliosis. - Pregnant patients;For patients with coarctatio aortae - Patients with more than one surgical intervention. - Patients known to suffer from a hemodynamic significant re-coarctation (definition: pressure differences between ascending and descending aorta > 20 mmHg).

Design outcomes

Secondary

Measure	Time frame
1. CPET variables: peak workload, peak Ve, Ve/VCO2 slope, O2-pulse, heart rate response to exercise (28). 2. Cardiac assessment: residual lesions on echo (valve insufficiency and/or stenosis) graded according to Hamer and Pieper. Ventricular morphology and volumes on MRI (29) 3. Pulmonary function: total lung capacity (TLC), force expiratory volume in 1 second (FEV1), maximal inspiratory/expiratory pressures (MIP/MEP), residual volume (16,17). 4. Muscle strength: handgrip strength, isotonic muscle strength (hand-held dynamometer of quadriceps, triceps and biceps). 5. Quality of life assessed with PedsQL. 6. Physical activity measured with accelerometer.	—

Measure

Time frame

1. CPET variables: peak workload, peak Ve, Ve/VCO2 slope, O2-pulse, heart rate response to exercise (28). 2. Cardiac assessment: residual lesions on echo (valve insufficiency and/or stenosis) graded according to Hamer and Pieper. Ventricular morphology and volumes on MRI (29) 3. Pulmonary function: total lung capacity (TLC), force expiratory volume in 1 second (FEV1), maximal inspiratory/expiratory pressures (MIP/MEP), residual volume (16,17). 4. Muscle strength: handgrip strength, isotonic muscle strength (hand-held dynamometer of quadriceps, triceps and biceps). 5. Quality of life assessed with PedsQL. 6. Physical activity measured with accelerometer.

—

Primary

Measure	Time frame
Main endpoint: Cardiopulmonary exercise testing (peak VO2). Main study parameters: 1. Cardiac function (EF on MRI) 2. Pulmonary function (FVC) 3. Muscle strength (BOT-2)	—

Countries

Netherlands

Outcome results