Effects of Exercise in Patients With Repaired Coarctation of the Aorta (KOREKT)
Effects of Exercise on Select Indicators of Cardiovascular Health in Patients With Repaired Coarctation of the Aorta
This interventional study will investigate the effects of high-intensity interval training (HIIT) in adults with repaired coarctation of the aorta. Participants will be randomised into three groups: HIIT performed at home, HIIT performed in a supervised outpatient setting, or a control group receiving usual care. The two HIIT protocols will be identical in intensity and progression, individually prescribed for each patient.
The study will evaluate the effects of HIIT on exercise capacity, health-related quality of life, blood pressure response to exercise, and other select measures of cardiovascular health, including vascular stiffness and endothelial function. In addition, the study will examine the acute effects of a single exercise session on arterial stiffness.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Ljubljana、スロベニア、1000
- University Medical Centre Ljubljana
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Maribor、スロベニア、2000
- University Medical Centre Maribor
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- surgically repaired coarctation of the aorta,
- age at least 18 years, and
- signed informed consent form.
Exclusion Criteria:
- residual aortic stenosis (gradient across the narrowing >20 mmHg),
- presence of ascending aortic aneurysm,
- recent major cardiovascular event or other event requiring hospitalization (event less than 2 months before inclusion),
- unstable rhythm disturbances,
- unstable or low-threshold angina pectoris,
- NYHA class III or IV heart failure, and
- pregnancy.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Outpatient HIIT
Anticipated number of patients: 15. Participants will complete a structured high-intensity interval training (HIIT) programme performed in an outpatient setting. Intensity and progression are identical to the home-based HIIT arm. |
A structured exercise programme performed under direct supervision in an outpatient/clinical setting on a stationary bicycle or treadmill, consisting of 36 one-hour sessions over 2-4 months (approximately 2-3 sessions per week). Each session will comprise 8 five-minute intervals, each consisting of 2 minutes at 85-95% of the heart rate reached at VO2peak, followed by 3 minutes of active recovery. The interval block will be preceded by a 5-minute active warm-up and followed by a 5-minute active cool-down. Interval intensity will be individually determined for each patient. |
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実験的：Home-based HIIT
Anticipated number of patients: 15. Participants will complete a structured high-intensity interval training (HIIT) programme performed independently at home. Intensity and progression are identical to the outpatient HIIT arm. |
A structured exercise programme performed independently at home, consisting of 36 one-hour sessions over 2-4 months (approximately 2-3 sessions per week). Each session will comprise 8 five-minute intervals, each consisting of 2 minutes at 85-95% of the heart rate reached at VO2peak, followed by 3 minutes of active recovery. The interval block will be preceded by a 5-minute active warm-up and followed by a 5-minute active cool-down. Interval intensity will be individually determined for each patient. |
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介入なし：Control (usual care)
Anticipated number of patients: 15. Participants will receive usual care, consisting of general counselling on physical activity performed at home, without a structured or supervised exercise training programme. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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VO2peak on cardiopulmonary exercise testing (CPET)
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Hypothesis: The outpatient high-intensity interval training (HIIT) programme improves aerobic capacity (measured by VO2peak) more than a home-based HIIT program or usual care.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Health-related quality of life
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Hypothesis: The outpatient high-intensity interval training (HIIT) programme improves health-related quality of life, assessed using the standardised SF-36 and EQ-5D questionnaires, more than a home-based HIIT programme or usual care.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Ratio of peak systolic blood pressure to peak workload (mmHg/W) on CPET
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Hypothesis: The outpatient high-intensity interval training (HIIT) programme reduces the ratio between peak systolic blood pressure and peak workload achieved during exercise testing more than a home-based HIIT programme or usual care.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean 24-hour systolic blood pressure
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of average systolic pressure during sleep and wakefulness, measured using 24-hour ambulatory blood pressure monitoring.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Echocardiographic parameters
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of standard echocardiographic measures of cardiac structure and function, including left ventricular global longitudinal strain (GLS).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Endothelial function of the right radial artery (flow-mediated dilation, FMD)
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Ultrasound assessment of endothelial function of the right radial artery, measured by flow-mediated dilation (FMD).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Heart rate variability
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of heart rate variability using high-resolution electrocardiography.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Biomarkers associated with vascular stiffness and atherosclerosis
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of circulating biomarkers associated with vascular stiffness and atherosclerosis, including atrial natriuretic peptide (ANP), growth/differentiation factor 15 (GDF-15), matrix metalloproteinase 1 (MMP-1), interleukin-33 receptor (IL-33/ST2), brain-derived neurotrophic factor (BDNF), galectin-3, myeloperoxidase, and tissue inhibitor of metalloproteinase 1 (TIMP-1).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Self-reported physical activity
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Self-reported physical activity level, assessed using the standardised International Physical Activity Questionnaire (IPAQ).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body composition
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of body composition using bioelectrical impedance analysis.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Standard laboratory panel
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of standard laboratory parameters: electrolytes, renal function markers, liver function tests.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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NT-proBNP
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of NT-proBNP
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Extended lipid panel
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment extended lipid panel, including Lp(a).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Thyroid hormone level
時間枠：At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of thyroid hormones.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 0120-101/2025-2711-4
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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