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

November 17, 2023 updated by: Parc de Salut Mar

Frailty in Patients With Advanced Chronic Kidney Disease Waiting for a Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Frailty is very frequent among patients with chronic kidney disease (CKD) included in the waiting list for deceased donor kidney transplantation (KT), and outcomes are worsened in those frail recipients after KT. Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcareutilization after KT. Frailty in CKD patients displays a unique constellation of features such as muscle wasting, anorexia, protein energy wasting, inflammation, oxidative stress, catabolic/anabolic hormone imbalance, metabolic acidosis, and other cellularalterations that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. Efforts to intervene with post- transplant physical therapy have been met with limited success, in large part due to high study dropout. A pre-transplant clinical framework for multimodal prehabilitation interventions including physicaltherapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention andcompliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients.

The main objective of this study is to assess effectiveness, feasibility and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates in the context of a randomized controlled clinical trial. The primary endpoint will be a composite achievement of clinical and functional outcomes in frail and non-frail KT candidates after KT.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Recruiting
        • Hospital Del Mar
        • Contact:
        • Principal Investigator:
          • Julio Pascual Santos, MD PhD
        • Principal Investigator:
          • Ester Marco, MD PhD
        • Sub-Investigator:
          • Maria-José Pérez Saez, MD PhD
        • Sub-Investigator:
          • Anna Faura Vendrell, Ns
        • Sub-Investigator:
          • David Benito Guasch, Ns
        • Sub-Investigator:
          • Maria Vera Casanova, Ns
        • Sub-Investigator:
          • Anna Bach Pascual, Ns
        • Sub-Investigator:
          • Montserrat Folgueiras López, Ns
        • Sub-Investigator:
          • Maria D Muns Cornellas, Nutritionist
        • Sub-Investigator:
          • Olga Vázquez Ibar, MD PhD
        • Sub-Investigator:
          • Miguel Garriz Vera, Psychologist
        • Sub-Investigator:
          • Maria Polo Gómez, Psychologist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults patients with chronic kidney disease
  • Inclusion in the waiting list for deceased donor kidney transplantation in the period September 2020 to August 2022

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal intervention
supervised physical training (1-hour sessions, 24 sessions, 8 weeks) + nutritional supplementation + psychological advice
Other: Multimodal prehabilitation
Exercise + nutritional supplementation + psychological advice
No Intervention: Standard Care
Healthy living recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bad-Outcome Composite Endpoint
Time Frame: 90 days post-kidney transplantation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in exercise capacity
Time Frame: Post-intervention (12 weeks)
Changes in peak oxygen uptake (higher scores mean better outcome)
Post-intervention (12 weeks)
Changes in peripheral muscle strength
Time Frame: Post-intervention (12 weeks)
Changes in handgrip and quadriceps muscles strength (higher scores mean better outcome)
Post-intervention (12 weeks)
Changes in respiratory muscle strength
Time Frame: Post-intervention (12 weeks)
Changes in maximal inspiratory and expiratory muscle strength (higher scores mean better outcome)
Post-intervention (12 weeks)
Changes in physical activity
Time Frame: Post-intervention (12 weeks)
Changes in physical activity assessed by activity monitors (higher scores mean better outcome)
Post-intervention (12 weeks)
Attendance
Time Frame: Post-intervention (12 weeks)
Attended sessions (0-100%, patients are expected to attend a minimum of 80% sessions)
Post-intervention (12 weeks)
Exercise tolerability
Time Frame: Post-intervention (12 weeks)
Patients not requiring exercise discontinuation or intensity modification
Post-intervention (12 weeks)
Changes in muscle mass
Time Frame: 1 month post-KT
Changes in muscle mass assessed with total body dual energy X-ray
1 month post-KT
Changes in mood state
Time Frame: Through study completion, an average of 1 year
Changes in Hospital Anxiety Depression Scale
Through study completion, an average of 1 year
Changes in health-related quality of life
Time Frame: Through study completion, an average of 1 year
Score in the Short-Form 36 questionnaire (8 dimensions scoring 0-100, higher scores mean better outcomes)
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Julio Pascual Santos, Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI19/0037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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