|- candidate number||6100|
|- NTR Number||NTR1909|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jul-2009|
|- Secondary IDs||08/342 MEC Academic Medical Center Amsterdam|
|- Public Title||Exercise in patients with a systemic right ventricle.|
|- Scientific Title||The effect of exercise in adult patients with a systemic right ventricle.|
|- hypothesis||We hypothesize that exercise training improves maximal exercise capacity in adult patients with a systemic RV. Moreover, we hypothesize that exercise training decreases serum NT-proBNP levels and increases quality of life in adult patients with a systemic RV.|
|- Healt Condition(s) or Problem(s) studied||Systemic right ventricle, Exercise|
|- Inclusion criteria||All adult (18 years old, or older) patients with an atrially switched TGA or with a ccTGA (i.e. a systemic right ventricle) are potentially eligible for this study.|
|- Exclusion criteria||Patients are not eligible for this study if the following exclusion criteria apply:|
1. Mental or physical incapability to give informed consent;
2. Mental or physical incapability to participate in the exercise training program;
3. Symptomatic myocardial ischemia;
4. Resting systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg;
5. NYHA class III or IV;
6. Severe aortic valve stenosis;
7. Pregnancy (during training period);
8. Non-cardiac co-morbidity that may affect exercise performance or that may aggravate by exercise (e.g. infection, renal failure).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2009|
|- planned closingdate||1-apr-2010|
|- Target number of participants||86|
|- Interventions||Eligible patients are randomly assigned to:|
1. Exercise training program;
2. No exercise training program.
The training program is commenced directly after the cardiopulmonary exercise test, with the first exercise scheduled two days after the cardiopulmonary exercise test. To enhance willingness to participate the training schedule is home-based. Patients are requested to perform an interval exercise training at home, climbing stairs, three times a week for 10 consecutive weeks. The training schedule is set-up as follows:
1. 5 minutes of warming-up to reach 60-70% of maximal heart rate;
2. 32 minutes of interval exercise training (stair climbing / aerobic steps). The interval training consists of five 4-minute intervals at 90-95% of maximal heart rate, as previously determined by the cardiovascular exercise test. These intervals are separated by 3-minute pauses, stepping in place at 50-70% of maximal heart rate;
3. 5 minutes of cool-down at 50-70% of maximal heart rate.
Total exercise time is 42 minutes per exercise.
Patients can follow their heart rate during the exercise training with the Cresta Metal Line PM-233 heart rate wrist watch, which will be provided to them directly after randomization.
To improve compliance, consenting patients can choose their exercise training – stair climbing or steps aerobics (patients choosing steps aerobics will be provided with a steps). Moreover, to improve compliance and to ensure safety of the exercise training, each patients will be telephoned weekly during the course of their program.
|- Primary outcome||The primary objective of the study is to determine whether exercise training improves maximal exercise capacity in adult patients with a systemic right ventricle due to an atrially switched TGA, or to a ccTGA.
|- Secondary outcome||The secondary objectives of the study are to determine whether exercise training:|
1. Decreases serum NT-proBNP levels;
2. Improves health related quality of life in adult patients with a systemic right ventricle.
|- Timepoints||Baseline and after 10 weeks of follow-up.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| B.J.M. Mulder|
|- CONTACT for SCIENTIFIC QUERIES|| B.J.M. Mulder|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Interuniversity Institute of Cardiology (ICIN), The Netherlands|
|- Brief summary||Netherlands (Amsterdam, Nijmegen, Groningen)|
|- Main changes (audit trail)|
|- RECORD||14-jul-2009 - 10-okt-2009|