Microvascular Dysfunction in Adults with Congenital Heart Disease and the Effect of Exercise Training
NCT ID: NCT06715137
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2021-01-18
2024-05-31
Brief Summary
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* Is coronary microvascular dysfunction (MVD) present in adults with diverse types of CHD?
* Is peripheral MVD present in adults with diverse types of CHD?
* Are coronary and peripheral MVD correlated in adults with diverse types of CHD?
* Is microvascular function correlated with inflammation and oxidative stress in adults with diverse types of CHD?
* Are inflammation and oxidative stress correlated with ventricular function in adults with diverse types of CHD?
* Are MVD and diminished ventricular function interrelated and associated with reduced exercise capacity in adults with diverse types of CHD?
* Does exercise training in adults with CHD result in improvements in coronary and peripheral microvascular function, inflammation and oxidative stress, biventricular function, muscle strength, exercise capacity and quality of life?
For the last research question, patients were randomized to receive either conventional care or home-based aerobic and strength exercise training.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exercise arm
Each participant received a personalized rehabilitation schedule combining aerobic interval cycle training and a dynamic strength exercise program, developed to ensure that the participants met the physical activity guidelines.
Exercise training
Each participant received a personalized rehabilitation schedule combining aerobic interval cycle training and a dynamic strength exercise program, developed to ensure that the participants met the physical activity guidelines. For the aerobic training, the patients cycled for 30-45 minutes on an exercise bike at home 3 times a week. During each training session, the heart rate (HR) was continuously recorded using a chest strap and displayed in a smartphone application. The target HR zones were predefined with alternating intervals of intensive and extensive aerobic training. The program followed a progressive structure with the objective of completing 40 minutes of intensive aerobic training after 16 weeks. In the strength training program, 4 dynamic exercises targeting major muscle groups were performed 3 times a week. Every 2 weeks, these exercises were intensified by altering the starting position or adding extra weight.
Conventional care arm
In the conventional care arm, patients did not receive explicit exercise advice but were provided with general information regarding a healthy lifestyle, in accordance with current physical activity guidelines during the first study visit.
No interventions assigned to this group
Interventions
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Exercise training
Each participant received a personalized rehabilitation schedule combining aerobic interval cycle training and a dynamic strength exercise program, developed to ensure that the participants met the physical activity guidelines. For the aerobic training, the patients cycled for 30-45 minutes on an exercise bike at home 3 times a week. During each training session, the heart rate (HR) was continuously recorded using a chest strap and displayed in a smartphone application. The target HR zones were predefined with alternating intervals of intensive and extensive aerobic training. The program followed a progressive structure with the objective of completing 40 minutes of intensive aerobic training after 16 weeks. In the strength training program, 4 dynamic exercises targeting major muscle groups were performed 3 times a week. Every 2 weeks, these exercises were intensified by altering the starting position or adding extra weight.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* New York Heart Association (NYHA) class I-II
* who visited the out-patient clinic at the Antwerp University Hospital
Exclusion Criteria
* body mass index \>35 kg/m²
* professional endurance athlete
* the presence of macrovascular coronary artery disease
* diabetes mellitus
* a systemic disease (e.g., malignancies, acute and chronic inflammatory diseases in the preceding 3 months)
* a contraindication for adenosine administration.
18 Years
65 Years
ALL
Yes
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
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References
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Vanreusel I, Vermeulen D, Goovaerts I, Stoop T, Ectors B, Cornelis J, Hens W, de Bliek E, Heuten H, Van Craenenbroeck EM, Van Berendoncks A, Segers VFM, Briede JJ. Circulating Reactive Oxygen Species in Adults with Congenital Heart Disease. Antioxidants (Basel). 2022 Nov 30;11(12):2369. doi: 10.3390/antiox11122369.
Vanreusel I, Taeymans J, Van Craenenbroeck E, Segers VFM, Van Berendoncks A, Briedé JJ, et al. Oxidative Stress in Patients with Congenital Heart Disease: A Systematic Review. Advances in Redox Research. 2024:100109
Vanreusel I, Taeymans J, Van Craenenbroeck E, Segers VFM, Van Berendoncks A, Briede JJ, Hens W. Elevated oxidative stress in patients with congenital heart disease and the effect of cyanosis: a meta-analysis. Free Radic Res. 2023 May-Jun;57(6-12):470-486. doi: 10.1080/10715762.2023.2284639. Epub 2023 Dec 26.
Vanreusel I, Hens W, Van Craenenbroeck E, Van Berendoncks A, Segers VFM. Peripheral Microvascular Dysfunction in Children and Adults with Congenital Heart Disease: A Literature Review. Curr Cardiol Rev. 2024;20(4):e210224227260. doi: 10.2174/011573403X278440240209064408.
Vanreusel I, Segers VFM, Craenenbroeck EV, Berendoncks AV. Coronary Microvascular Dysfunction in Patients with Congenital Heart Disease. Curr Cardiol Rev. 2023;19(4):e190123212886. doi: 10.2174/1573403X19666230119112634.
Other Identifiers
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Edge 001475
Identifier Type: -
Identifier Source: org_study_id