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

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).

SUBMITTER: Perez-Saez MJ

PROVIDER: S-EPMC8170320 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveThis study aims to explore the feasibility, safety, and effectiveness of home exercise prehabilitation on a new social platform for remote guidance to optimize the physical function of patients with end-stage renal disease awaiting kidney transplantation and provide scientific guidance on home prehabilitation exercises for patients awaiting kidney transplantation.MethodsThe subjects of this randomized clinical trial were randomly divided into the test and control groups. The control group maintained their exercise habits, while the trial group was given a 12-week personalized home prehabilitation exercise prescription (aerobic exercise + functional resistance exercise + flexibility exercise) on a new social platform with remote guidance. The participants' physical and cardiorespiratory fitness, quality of life, and psychological functioning were assessed before and after the intervention. The 6-min walk test (6MWT) walking distance and its percentage of attainment, the handgrip, the 5 repetition-sit-to-stand test, and the 4-m gait speed were used as primary outcome indicators, while the Short Form Health Survey SF-36 (health survey summary table) and the Hospital Anxiety and Depression scale were used as the secondary outcome indicators.ResultsAfter 12 weeks of intervention, the changes in the 6MWT measured distance (+ 44.9 ± 40.2, P = 0.001) and the percentage of 6MWT measured distance achieved (+ 6.8 ± 5.7, P = 0.001), the handgrip (+ 2.7 ± 4.3, P = 0.028), the 5-sit-to-stand test (-1.1 ± 1.4, P = 0.005), and the 4-m walking speed (-0.3 ± 0.4, P < 0.001) of the test group (n = 21) improved significantly. In the control group (n = 16), the changes in the 6MWT measured distance (-13.1 ± 57.2), the 6MWT measured distance attainment percentage (-2.1 ± 9.1), the handgrip (-0.1 ± 2.5), the 5-sit-to-stand test value (0.6 ± 2.2), and the 4-m walking speed (0.2 ± 0.5) showed no significant difference. No significant improvement in anxiety, depression, and SF-36 was noted in both the test and control groups.ConclusionThe remote coaching of home exercise pre-habilitation on a new social platform significantly improves the physical and cardiopulmonary fitness of patients with end-stage renal disease awaiting kidney transplantation. This treatment is safe and feasible in this population.

Project description:IntroductionCirrhosis is the main cause of morbidity and mortality globally, accounting for approximately 1.2 million deaths annually. Impaired aerobic capacity, muscle wasting and reduced muscle strength are significant complications in patients with cirrhosis. Preoperative exercise intervention "prehabilitation" has been recognised as a potential approach to optimise muscle strength, aerobic capacity and body composition as well as quality of life in patients awaiting abdominal surgery. However, there is little evidence on the effects of preoperative exercise on older adults with cirrhosis and awaiting liver transplant. Thus, the primary objective of this systematic review and meta-analysis will be to assess the effects of exercise interventions in improving aerobic capacity, muscle strength and body composition of older adults with cirrhosis and awaiting liver transplant.Methods and analysisThis systematic review and metaanalysis protocol was designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. This systematic review will include all peer-reviewed randomised controlled trials (RCTs), including cluster RCTs, controlled (non-controlled), complex clinical trials (CCTs) or cluster trials, cohort, observational studies published in English from inception until July 2024. The following electronic databases will be searched: MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL (EBSCO) and Scopus (Elsevier) and supplemented by a secondary screening of the reference lists of all included articles. Searches will involve studies with both male and female participants aged ≥ 18 years with cirrhosis and awaiting liver transplant. Primary outcomes will include muscle strength, and aerobic capacity. The secondary outcomes include body composition (e.g. body mass index, and thigh circumference). The Cochrane Collaboration Risk of Bias Tool will be used to evaluate quality of the studies and Review Manager (RevMan) V.5.3 (Copenhagen, Denmark: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). Effect sizes will be expressed as a standardised mean difference, and their 95% confidence intervals will be calculated and presented as a forest plot. The standard χ2 and I2 tests will be used to test heterogeneity.ConclusionThis systematic review and meta-analysis is anticipated to provide meaningful and contemporary evidence on the effects of preoperative exercise in older adults living with cirrhosis and awaiting liver transplant. In addition, the findings will help clinicians with developing safe and effective preoperative exercise regimens for these patients.

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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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