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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2731 |
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Date of registration:
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03/02/2011 |
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Primary sponsor: |
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Public title:
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Exercise Training in Congenital Heart Disease.
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Scientific title:
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Exercise Training in Congenital Heart Disease: Is it effective and safe and does it improve quality of life? - TOFFIT |
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Date of first enrolment:
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28/1/2010 |
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Target sample size:
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150 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2731 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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E.M.W.J.
Utens |
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Address:
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Postbus 2060
3000 CB
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 7036092 |
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Email:
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e.utens@erasmusmc.nl |
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Affiliation:
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Name:
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W.A.
Helbing |
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Address:
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Postbus 2060
3000 CB
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 7036264 |
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Email:
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w.a.helbing@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 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 criteria: 1. Inability to exercise;
2. Mental retardation;
3. Standard contra-indications for MRI;
4. Ventricular outflow obstruction (peak Doppler gradient > 60 mm Hg).
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Tetralogy of Fallot, Congenital heart disease, Fontan procedure
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Intervention(s)
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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% 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.
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Primary Outcome(s)
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1. Aerobic fitness;
2. Cardiac functioning;
3. Daily physical activity;
4. Health related quality of life.
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Secondary ID(s)
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NL25800.078.09
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Source(s) of Monetary Support
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Netherlands Heart Foundation (NHS, Nederlandse Hartstichting), Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting
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