The FRAILMar study protocol: frailty in patients with advanced chronic kidney disease awaiting kidney transplantation. A randomized clinical trial of multimodal prehabilitation

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• dc.contributor.author Pérez-Sáez, María José
• dc.contributor.author Morgado Pérez, Andrea
• dc.contributor.author Faura, Anna
• dc.contributor.author Muñoz Redondo, Elena
• dc.contributor.author Gárriz, Miguel
• dc.contributor.author Muns, Maria Dolors
• dc.contributor.author Nogués Solan, Francesc Xavier
• dc.contributor.author Marco, Ester
• dc.contributor.author Pascual Santos, Julio
• dc.date.accessioned 2022-02-09T07:34:55Z
• dc.date.available 2022-02-09T07:34:55Z
• dc.date.issued 2021
• dc.description.abstract Introduction: Frailty is very frequent among patients with chronic kidney disease (CKD) who are awaiting deceased donor kidney transplantation (KT), and transplant outcomes are worsened in those frail recipients. Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Intervention is essential to improve survival and quality of life for frail CKD patients, regardless of their age. Studies of post-transplant physical therapy intervention have been met with limited success, in large part due to high dropout rates. A pre-transplant clinical framework for multimodal prehabilitation interventions including physical therapy, nutritional measures, and psychological support scheduled during the KT waiting list period may improve patient retention and compliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients. Main Objective: To study the effectiveness, feasibility, and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in KT candidates. Methods: Randomized controlled clinical trial in 38 frail and 76 non-frail KT candidates. The prehabilitation program will consist of physical exercise (24 sessions, 8 weeks), nutritional supplementation, and psychological advice. The primary endpoint will be a composite achievement of clinical and functional main outcomes in frail and non-frail KT candidates at 90 days post-transplantation. Secondary outcomes include changes in exercise capacity, physical activity, gait speed, respiratory and peripheral muscle strength, muscle size, body composition, performance in activities of daily living (basic and instrumental), anxiety and depression symptoms, and health-related quality of life. Feasibility of the intervention will be also analyzed. Expected Results: Multimodal prehabilitation is a feasible and effective intervention to decrease bad outcomes at 90 days post-KT by 25 and 12.5% in frail and non-frail patients, respectively. Clinical Trial Registration: clinicaltrials.gov (NCT04701398), date: 2021, January 8th (Protocol version: Frailmar_vers2).
• dc.format.mimetype application/pdf
• dc.identifier.citation Pérez-Sáez MJ, Morgado-Pérez A, Faura A, Muñoz-Redondo E, Gárriz M, Muns MD, Nogués X, Marco E, Pascual J. The FRAILMar study protocol: frailty in patients with advanced chronic kidney disease awaiting kidney transplantation. A randomized clinical trial of multimodal prehabilitation. Front Med (Lausanne). 2021;8:675049. DOI: 10.3389/fmed.2021.675049
• dc.identifier.doi http://dx.doi.org/10.3389/fmed.2021.675049
• dc.identifier.issn 2296-858X
• dc.identifier.uri http://hdl.handle.net/10230/52442
• dc.language.iso eng
• dc.publisher Frontiers
• dc.relation.ispartof Front Med (Lausanne). 2021;8:675049
• dc.rights © 2021 Pérez-Sáez, Morgado-Pérez, Faura, Muñoz-Redondo, Gárriz, Muns, Nogués, Marco and Pascual. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Chronic kidney disease
• dc.subject.keyword Exercise
• dc.subject.keyword Frailty
• dc.subject.keyword Kidney transplantation
• dc.subject.keyword Nutrition
• dc.subject.keyword Prehabilitaion
• dc.title The FRAILMar study protocol: frailty in patients with advanced chronic kidney disease awaiting kidney transplantation. A randomized clinical trial of multimodal prehabilitation
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion