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Exercise in patients with a systemic right ventricle.


- candidate number6100
- NTR NumberNTR1909
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jul-2009
- Secondary IDs08/342 MEC Academic Medical Center Amsterdam
- Public TitleExercise in patients with a systemic right ventricle.
- Scientific TitleThe effect of exercise in adult patients with a systemic right ventricle.
- ACRONYMN/A
- hypothesisWe 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) studiedSystemic right ventricle, Exercise
- Inclusion criteriaAll 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 criteriaPatients 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2009
- planned closingdate1-apr-2010
- Target number of participants86
- InterventionsEligible 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 outcomeThe 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 outcomeThe 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.
- TimepointsBaseline and after 10 weeks of follow-up.
- Trial web siteN/A
- statusopen: 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
- Funding
(Source(s) of Monetary or Material Support)
Interuniversity Institute of Cardiology (ICIN), The Netherlands
- PublicationsN/A
- Brief summaryNetherlands (Amsterdam, Nijmegen, Groningen)
Italy (Bologna)
- Main changes (audit trail)
- RECORD14-jul-2009 - 10-okt-2009


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