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Rationale: Regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on exercise training in adult patients with congenital heart disease.
Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels.
Study design: International, multi-centre parallel randomized controlled trial.
Study population: Adult patients with congenital heart disease, who are in New York Heart Association (NYHA) class II or III.
Intervention (if applicable): The intervention group receives a six-month individualized exercise training program, the control group receives usual care.
Main study parameters/endpoints: The primary outcome is the change in peakVO2 between patients in the sports participation group, and the control group. 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.
The investigators intend to submit the trial design of this study for this purpose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training program | Active Comparator | Six-months sports participation, three times per week for 30 minutes in the target heart rate zone |
|
| No exercise training program | No Intervention | no exercise training program, usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise training | Behavioral | 3 times per week 30 minutes of exercise training in the target heart rate zone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint: change in peak VO2 | change in peak VO2 between baseline and 6-months follow-up CPET | 6 months |
| Primary safety endpoint: composite of hospitalizations, deaths during, or within three hours after exercise | The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. | between 3 hours after exercise for the duration of the 6 months study period |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoint: quality of life | change in SF36 scores between baseline and 6-months follow-up | 6 months |
| Secondary efficacy endpoint: NTproBNP level | change in NTproBNP between baseline and 6-months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Berto Bouma, MD, PhD | Contact | 0031205669111 | b.j.bouma@amc.uva.nl | |
| Michiel Winter, MD, PhD | Contact | 0031205669111 | m.m.winter@amc.uva.nl |
| Name | Affiliation | Role |
|---|---|---|
| Barbara Mulder, MD, PhD | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese | Not yet recruiting | Milan | Piazza Edmondo Malan | 20097 | Italy |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 6 months |
| Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought | The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought during the study period | 6 months study period |
| Hospital | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |