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Exercise Training in Grown-Up Congenital Heart Disease.

Exercise Training in Grown-Up Congenital Heart Disease. - The ExTra GUCH trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46945
Enrollment
100
Registered
2015-10-21
Start date
2016-01-08
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

congenital heart disease

Interventions

The ExTra GUCH training protocol is designed to decrease participation threshold, and increase patient*s ownership. Consenting patients agree with sports participation three times per week, for 26 c

Sponsors

Cardiologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years Congenital heart disease NYHA Class II or III

Exclusion criteria

Exclusion criteria: Inability to give informed consent Inability to participate in an exercise training program Exercise-induced arrhythmia and/or ischemia Cyanosis at rest Pregnancy Major cardiovascular event and/or procedure within three months previous to inclusion. Participation in interventional clinical trial

Design outcomes

Primary

MeasureTime frame
The primary outcome is the change in V*O2peak between patients in the sports participation group, and the control group.

Secondary

MeasureTime frame
Secondary outcome measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)