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FRAILMar研究方案:等待肾移植的晚期慢性肾脏病患者的衰弱。一项多模式术前康复的随机临床试验。

The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation.

作者信息

Pérez-Sáez María José, Morgado-Pérez Andrea, Faura Anna, Muñoz-Redondo Elena, Gárriz Miguel, Muns Maria Dolors, Nogués Xavier, Marco Ester, Pascual Julio

机构信息

Department of Nephrology, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.

Department of Physical Medicine and Rehabilitation, Parc de Salut Mar (Hospital del Mar-Hospital de l'Esperança), Barcelona, Spain.

出版信息

Front Med (Lausanne). 2021 May 19;8:675049. doi: 10.3389/fmed.2021.675049. eCollection 2021.

DOI:10.3389/fmed.2021.675049
PMID:34095178
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8170320/
Abstract

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. To study the effectiveness, feasibility, and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in KT candidates. 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. 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. clinicaltrials.gov (NCT04701398), date: 2021, January 8th (Protocol version: Frailmar_vers2).

摘要

在等待尸体供肾移植(KT)的慢性肾脏病(CKD)患者中,衰弱非常常见,而那些衰弱的受者移植结局会更差。衰弱和身体状况不佳有力地预示着KT后的死亡率、肾移植存活率和医疗保健利用率。无论年龄大小,对衰弱的CKD患者进行干预对于提高其生存率和生活质量至关重要。移植后物理治疗干预的研究取得的成功有限,很大程度上是由于高退出率。在KT等待期安排包括物理治疗、营养措施和心理支持在内的多模式预康复干预的移植前临床框架,可能会提高患者的留存率和依从性,更好地减轻KT后衰弱和身体状况不佳的影响,并改善衰弱CKD患者的主要结局。 研究多模式预康复(运动、营养计划、心理建议)对KT候选者的有效性、可行性和安全性。 对38名衰弱和76名非衰弱的KT候选者进行随机对照临床试验。预康复计划将包括体育锻炼(24节课程,8周)、营养补充和心理建议。主要终点将是移植后90天时衰弱和非衰弱KT候选者临床和功能主要结局的综合达成情况。次要结局包括运动能力、身体活动、步速、呼吸和外周肌肉力量、肌肉大小、身体成分、日常生活活动(基本和工具性)表现、焦虑和抑郁症状以及健康相关生活质量的变化。还将分析干预的可行性。 多模式预康复是一种可行且有效的干预措施,可使衰弱和非衰弱患者在KT后90天时的不良结局分别降低25%和12.5%。 clinicaltrials.gov(NCT04701398),日期:2021年1月8日(方案版本:Frailmar_vers2)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94ca/8170320/29bbd2d8df70/fmed-08-675049-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94ca/8170320/a222cfa97c7b/fmed-08-675049-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94ca/8170320/29bbd2d8df70/fmed-08-675049-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94ca/8170320/a222cfa97c7b/fmed-08-675049-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94ca/8170320/29bbd2d8df70/fmed-08-675049-g0002.jpg

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