Exercise training in patients with a left ventricular assist device (Ex-VAD) : rationale and design of a multicentre, prospective, assessor-blinded, randomized, controlled trial
© 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology..
AIMS: Left ventricular assist device (LVAD) therapy is a promising option for patients with advanced heart failure (HF), refractory to guideline-mandated medical treatment either as a bridge to heart transplantation or as lifelong therapy. Functional capacity improves after LVAD implantation but remains reduced in patients with long-term LVAD therapy. Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy.
METHODS: The primary objective of Ex-VAD is to investigate whether a 12-week supervised ET can improve peak oxygen uptake (peakVO2 ) measured by cardiopulmonary exercise testing (CPET) on an ergometer. The study is powered to demonstrate a group difference of 3 mL/min/kg in peakVO2 at week 12, with a power of 0.9 and a standard deviation of 5 mL/min/kg. After baseline assessments to determine whether ET is safe, 66 patients at six trial sites with advanced HF and LVAD therapy will be randomized 2:1 to supervised ET or to the control arm of usual care alone. Patients randomized to ET will perform supervised aerobic endurance and resistance ET (three times/week) for 12 weeks. At baseline and during follow-up, anthropometry, CPET, echocardiography (at rest and exercise), and QoL evaluation will be performed. Blood samples will be collected to examine cardiac-specific relevant biomarkers. Overall physical activity, training sessions, and adherence will be monitored and documented throughout the study using accelerometers and patient diaries.
CONCLUSIONS: The Ex-VAD trial will assess the effects of a supervised ET programme on peakVO2 and QoL in patients with LVAD. As LVAD therapy moves from crisis support to ambulatory functional enhancement, this trial will provide a rationale to improve functional capacity and, in perspective, cardiovascular outcomes in LVAD-supported patients with advanced HF.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
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| Enthalten in: |
European journal of heart failure - 21(2019), 9 vom: 12. Sept., Seite 1152-1159 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bobenko, Anna [VerfasserIn] |
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| Links: |
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| Themen: |
Advanced heart failure |
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| Anmerkungen: |
Date Completed 05.10.2020 Date Revised 21.03.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/ejhf.1431 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM295463953 |
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| 100 | 1 | |a Bobenko, Anna |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Exercise training in patients with a left ventricular assist device (Ex-VAD) |b rationale and design of a multicentre, prospective, assessor-blinded, randomized, controlled trial |
| 264 | 1 | |c 2019 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 05.10.2020 | ||
| 500 | |a Date Revised 21.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. | ||
| 520 | |a AIMS: Left ventricular assist device (LVAD) therapy is a promising option for patients with advanced heart failure (HF), refractory to guideline-mandated medical treatment either as a bridge to heart transplantation or as lifelong therapy. Functional capacity improves after LVAD implantation but remains reduced in patients with long-term LVAD therapy. Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy | ||
| 520 | |a METHODS: The primary objective of Ex-VAD is to investigate whether a 12-week supervised ET can improve peak oxygen uptake (peakVO2 ) measured by cardiopulmonary exercise testing (CPET) on an ergometer. The study is powered to demonstrate a group difference of 3 mL/min/kg in peakVO2 at week 12, with a power of 0.9 and a standard deviation of 5 mL/min/kg. After baseline assessments to determine whether ET is safe, 66 patients at six trial sites with advanced HF and LVAD therapy will be randomized 2:1 to supervised ET or to the control arm of usual care alone. Patients randomized to ET will perform supervised aerobic endurance and resistance ET (three times/week) for 12 weeks. At baseline and during follow-up, anthropometry, CPET, echocardiography (at rest and exercise), and QoL evaluation will be performed. Blood samples will be collected to examine cardiac-specific relevant biomarkers. Overall physical activity, training sessions, and adherence will be monitored and documented throughout the study using accelerometers and patient diaries | ||
| 520 | |a CONCLUSIONS: The Ex-VAD trial will assess the effects of a supervised ET programme on peakVO2 and QoL in patients with LVAD. As LVAD therapy moves from crisis support to ambulatory functional enhancement, this trial will provide a rationale to improve functional capacity and, in perspective, cardiovascular outcomes in LVAD-supported patients with advanced HF | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Advanced heart failure | |
| 650 | 4 | |a Left ventricular assist device | |
| 650 | 4 | |a Supervised exercise training | |
| 700 | 1 | |a Schoenrath, Felix |e verfasserin |4 aut | |
| 700 | 1 | |a Knierim, Jan H |e verfasserin |4 aut | |
| 700 | 1 | |a Friede, Tim |e verfasserin |4 aut | |
| 700 | 1 | |a Verheyen, Nicolas |e verfasserin |4 aut | |
| 700 | 1 | |a Mehra, Mandeep R |e verfasserin |4 aut | |
| 700 | 1 | |a Haykowsky, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Herrmann-Lingen, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Duvinage, André |e verfasserin |4 aut | |
| 700 | 1 | |a Pieske-Kraigher, Elisabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Halle, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Falk, Volkmar |e verfasserin |4 aut | |
| 700 | 1 | |a Pieske, Burkert |e verfasserin |4 aut | |
| 700 | 1 | |a Edelmann, Frank |e verfasserin |4 aut | |
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