Contemporary clinical trials · 2025
Prehabilitation and rehabilitation in peripheral arterial disease: Protocol and study design of the PREPARE-IT trial.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Myers Jonathan, Chan Khin, Nguyen Patricia, Gronau Charles, Gautam Pallavi, Arya Shipra, Aalami Oliver
Аннотация
BACKGROUND: Both prehabilitation and rehabilitation programs have been shown to improve functional capabilities, surgical outcomes, and quality of life in patients with peripheral arterial disease (PAD). However, referral rates remain low, and the benefits of combined prehabilitation and rehabilitation for PAD have not been explored.
METHODS: Three hundred patients with symptomatic claudication referred for femoral-popliteal endovascular stenting will be studied. In this randomized trial, the effectiveness of a 6-week pre-operative program of exercise therapy and risk management (prehabilitation) will be compared to: 1) a 6-week program of rehabilitation (post-operative); and 2) both prehabilitation and rehabilitation. Comparisons will be made of time to claudication symptoms, 6-min walk performance, peak VO2, strength, endothelial function, biomarkers, and quality of life at baseline, 6-weeks (1 week prior to intervention), 14 weeks, and 22 weeks.
DISCUSSION: The concept of prehabilitation is based on the principle that patients with higher functional capabilities will better tolerate a surgical intervention and therefore exhibit better outcomes following the intervention. Recent studies have consistently demonstrated better functional, psychosocial, and surgery-related morbidity outcomes among subjects participating in pre-surgical prehabilitation programs, but few such data are available in patients with PAD. The prehabilitation period also provides an ideal opportunity for cardiometabolic risk intervention. The primary aim of this trial is to explore the functional and psychosocial impact of prehabilitation, rehabilitation, and their combination in patients with PAD scheduled for a non-emergent endovascular intervention. We anticipate that the combination of prehabilitation and rehabilitation will result in better outcomes than either intervention alone.
METHODS: Three hundred patients with symptomatic claudication referred for femoral-popliteal endovascular stenting will be studied. In this randomized trial, the effectiveness of a 6-week pre-operative program of exercise therapy and risk management (prehabilitation) will be compared to: 1) a 6-week program of rehabilitation (post-operative); and 2) both prehabilitation and rehabilitation. Comparisons will be made of time to claudication symptoms, 6-min walk performance, peak VO2, strength, endothelial function, biomarkers, and quality of life at baseline, 6-weeks (1 week prior to intervention), 14 weeks, and 22 weeks.
DISCUSSION: The concept of prehabilitation is based on the principle that patients with higher functional capabilities will better tolerate a surgical intervention and therefore exhibit better outcomes following the intervention. Recent studies have consistently demonstrated better functional, psychosocial, and surgery-related morbidity outcomes among subjects participating in pre-surgical prehabilitation programs, but few such data are available in patients with PAD. The prehabilitation period also provides an ideal opportunity for cardiometabolic risk intervention. The primary aim of this trial is to explore the functional and psychosocial impact of prehabilitation, rehabilitation, and their combination in patients with PAD scheduled for a non-emergent endovascular intervention. We anticipate that the combination of prehabilitation and rehabilitation will result in better outcomes than either intervention alone.