Multimodal Prehabilitation in Frail and Non-frail Patients Waiting for a Kidney Transplantation (the FRAILMAR Study)

NCT04701398 | Unknown

• 1 other identifier: PI19/0037
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is very frequent among patients waiting for a kidney transplantation (KT). Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Frailty in patients with chronic kidney disease (CKD) displays a constellation of features that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. A pre-transplant intervention including physical therapy, nutritional measures and psychological support scheduled for before the transplant 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. The main objective is to assess effectiveness, feasibility and safety of a prehabilitation program (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates on clinical and functional outcomes after KT.

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney disease; kidney transplantation; frailty; prehabilitation; exercise; nutritional status; psychological advice; sarcopenia

Outcome Measures

Primary Outcomes (1)

• Bad-Outcome Composite Endpoint

  Delayed draft function \>14 days + never functioning kidney + non-elective readmission before day 90 + surgical complications (wound healing problems, obstructive lymphocele, vascular thrombosis, urinary stenosis or leak, acute hemorrhage, immediate re-intervention) + discharge to an assisted facility + all-cause death.

  90 days post-kidney transplantation

Secondary Outcomes (9)

• Changes in exercise capacity

  Post-intervention (12 weeks)

• Changes in peripheral muscle strength

  Post-intervention (12 weeks)

• Changes in respiratory muscle strength

  Post-intervention (12 weeks)

• Changes in physical activity

  Post-intervention (12 weeks)

• Attendance

  Post-intervention (12 weeks)

Study Arms (2)

Multimodal intervention

EXPERIMENTAL

supervised physical training (1-hour sessions, 24 sessions, 8 weeks) + nutritional supplementation + psychological advice

Other: Multimodal prehabilitation

Standard Care

NO INTERVENTION

Healthy living recommendations

Interventions

Multimodal prehabilitation OTHER

Exercise + nutritional supplementation + psychological advice

Multimodal intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults patients with chronic kidney disease

You may not qualify if:

• Patients unable to perform the exercise plan or giving informed consent

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

RECRUITING

Related Publications (2)

• Perez-Saez MJ, Munoz-Redondo E, Morgado-Perez A, Delcros-Forestier L, Bach A, Faura A, Redondo D, Chamoun B, Burballa C, Buxeda A, Crespo M, Marco E, Pascual J; FRAILMar Study Group. Exercise-Based Prehabilitation for Kidney Transplant Candidates: the FRAILMar Randomized Controlled Trial. Am J Kidney Dis. 2025 Nov;86(5):634-645.e1. doi: 10.1053/j.ajkd.2025.07.003. Epub 2025 Aug 13.

  PMID: 40816623 DERIVED

• Perez-Saez MJ, Morgado-Perez A, Faura A, Munoz-Redondo E, Garriz M, Muns MD, Nogues 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 May 19;8:675049. doi: 10.3389/fmed.2021.675049. eCollection 2021.

  PMID: 34095178 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Frailty; Motor Activity; Sarcopenia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Julio Pascual Santos

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ester Marco, MD

CONTACT

+34699706860; emarco@psmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 8, 2021
• Study Start: September 1, 2020
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)