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Exercise Training in Congenital Heart Disease.


- candidate number9064
- NTR NumberNTR2731
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-feb-2011
- Secondary IDsNL25800.078.09 METC ErasmusMC
- Public TitleExercise Training in Congenital Heart Disease.
- Scientific TitleExercise Training in Congenital Heart Disease: Is it effective and safe and does it improve quality of life?
- ACRONYMTOFFIT
- hypothesisWe hypothesize that exercise training will:
1. Improve aerobic fitness;
2. Will not result in adverse remodeling and/or decline of ejection fraction;
3. Will increase daily activity levels;
4. Will improve health related quality of life and psychosocial functioning.
- Healt Condition(s) or Problem(s) studiedTetralogy of Fallot, Congenital heart disease, Fontan procedure
- Inclusion criteria1. Surgical repair for Tetralogy of Fallot through transatrial-transpulmonary repair, below the age of 2 years, or;
2. Surgical repair for single ventricle physiology, with intracardiac or extracardiac tunnel, performed before the age of 6 years as a (at least) 2-stage procedure (previous partial cavopulmonary repair);
3. At least 12 years of age;
4. Being followed in Erasmus MC, LUMC, UMC St Radboud, UMCU Wilhelmina Children's Hospital.
- Exclusion criteria1. Inability to exercise;
2. Mental retardation;
3. Standard contra-indications for MRI;
4. Ventricular outflow obstruction (peak Doppler gradient > 60 mm Hg).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-jan-2010
- planned closingdate28-feb-2011
- Target number of participants150
- InterventionsThe patients randomized to the exercise program will perform exercise training. The exercise training program will consist of 3 training sessions of 1 hour per week, for a 3-month period. Training will be aerobic at 60% of heart rate reserve. Standardized training will be performed group-wise under supervision of a physiotherapist at local fitness-centers.
The patients randomized to the control group will continu their daily activities.
- Primary outcome1. Aerobic fitness;
2. Cardiac functioning;
3. Daily physical activity;
4. Health related quality of life.
- Secondary outcomeN/A
- TimepointsExercise group:
1. Baseline measurements: Within 2 months of the start of the exercise program (T0);
2. Repeated measurements: Within 2 weeks after the completion of the exercise program (T1).

Control group:
Approximately 3 months between baseline measurements and repeated measurements.

Measurements:
1. Aerobic fitness (oxygen uptake and peak power in last half minute of graded bicycle ergometer test);
2. Cardiac functioning (end-systolic and end-diastolic volume of RV and LV (Fallot group) or single ventricle (Fontan group), ejection fraction, functional reserve, NT-proBNP level);
3. Daily physical activity (percentage of day during which dynamic activities have been performed, average motility, assessed by means of an Activity Monitor);
4. Health related quality of life (assessed by TACQOL 12-15 CF and PF, SF-36 and TAAQOL-CHD);
5. Psychosocial functioning (assessed by YSR, ASR, CBCL and ABCL; STAIC, STAI-DY; SPP-A, GSES-12).
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. E.M.W.J. Utens
- CONTACT for SCIENTIFIC QUERIESProf. dr. W.A. Helbing
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting), Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting
- PublicationsN/A
- Brief summaryA multi-centered study in the Netherlands to the effect of an exercise training program in children and adolescents (aged 12-20) who have undergone treatment for congenital heart disease (Tetralogy of Fallot and Fontan procedure) on:
1. Aerobic fitness;
2. Cardiac functioning;
3. Daily physical activity;
4. Health related quality of life.
The study has a prospective, randomized, controlled, interventional design.
- Main changes (audit trail)30-6-2013
INCLUSION CRITERIA: 3. At least 10 (instead of 12)years of age;
INTERVENTIONS: The patients randomized to the exercise program will perform exercise training. The exercise training program will consist of 3 training sessions of 1 hour per week, for a 3-month period. Training will be aerobic at 60-70% (instead of 60%) of heart rate reserve. Standardized training will be performed group-wise under supervision of a physiotherapist at local fitness-centers. The patients randomized to the control group will continu their daily activities.
A multi-centered study in the Netherlands to the effect of an exercise training program in children and adolescents aged 10-25 instead of aged 12-20.
- RECORD3-feb-2011 - 30-jun-2013


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