Exercise in patients with a systemic right ventricle.

The effect of exercise in adult patients with a systemic right ventricle.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26970

Enrollment

Registered

2009-07-14

Start date

2009-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Patients with a transposition of the great arteries who have undergone a Mustard or Senning correction in the past, and patients with a congenitally corrected transposition of the great arteries.

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

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

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 Lin

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactB.J.M. Mulder

Academic Medical Centre (AMC) Department of cardiology Room F3 – 115

b.j.mulder@amc.uva.nl+31 (0)20 5666051

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)