ESC heart failure · 2024
Exercise training in left ventricular assist device patients: Protocol of an individual participant data meta-analysis.
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Kambič Tim, Feuerstein Anna, Tran Phuc Thien, Friede Tim, Edelmann Frank, Lainscak Mitja, ExTraLVAD Collaborators
Аннотация
AIMS: Although left ventricular assist device (LVAD) implantation improves prognosis of advanced heart failure patients still suffer from impaired exercise capacity and quality of life (QoL). Exercise training may improve both; however, the available evidence about exercise training effects in LVAD patients remains inconclusive due to small and monocentric randomized controlled trials. This study aims to aggregate the individual participant data (IPD) to perform meta-analysis on the safety and efficacy of exercise training on exercise capacity and QoL over standard care in LVAD patients.
METHODS: Randomized controlled trials comparing exercise training and standard care (no supervised training) will be identified through database searching. Corresponding authors of eligible randomized controlled trials will be invited to share IPD. All IPD will be checked, recalculated to validate findings in initial reports, merged in a single dataset and stored in a secured encrypted database server. The merged IPD will be screened for quality, risk of bias, and heterogeneity of the included trials. Random effects meta-analyses will be conducted using one-stage and two-stage approaches, in particular with a view to subgroup analyses.
RESULTS: Based on findings of the individual randomized trials, we expected to obtain superior effects of exercise training on submaximal exercise capacity and QoL and similar effects on maximal aerobic capacity when compared with standard care.
CONCLUSIONS: Our study will be the first to harmonize IPD in meta-analysis to demonstrate the effects of exercise training on exercise performance and QoL over standard care in LVAD patients.
PROSPERO REGISTRATION NUMBER: CRD42023480119.
METHODS: Randomized controlled trials comparing exercise training and standard care (no supervised training) will be identified through database searching. Corresponding authors of eligible randomized controlled trials will be invited to share IPD. All IPD will be checked, recalculated to validate findings in initial reports, merged in a single dataset and stored in a secured encrypted database server. The merged IPD will be screened for quality, risk of bias, and heterogeneity of the included trials. Random effects meta-analyses will be conducted using one-stage and two-stage approaches, in particular with a view to subgroup analyses.
RESULTS: Based on findings of the individual randomized trials, we expected to obtain superior effects of exercise training on submaximal exercise capacity and QoL and similar effects on maximal aerobic capacity when compared with standard care.
CONCLUSIONS: Our study will be the first to harmonize IPD in meta-analysis to demonstrate the effects of exercise training on exercise performance and QoL over standard care in LVAD patients.
PROSPERO REGISTRATION NUMBER: CRD42023480119.