Clinical trial NCT04701398: Multimodal Prehabilitation in Frail and Non-frail Patients Waiting for a Kidney Transplantation (the FRAILMAR Study)
Official title: Frailty in Patients With Advanced Chronic Kidney Disease Waiting for a Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney disease
kidney transplantation
frailty
prehabilitation
exercise
nutritional status
psychological advice
sarcopenia
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bad-Outcome Composite Endpoint
timeFrame: 90 days post-kidney transplantation
Secondary outcomes:
measure: Changes in exercise capacity
timeFrame: Post-intervention (12 weeks)
measure: Changes in peripheral muscle strength
timeFrame: Post-intervention (12 weeks)
measure: Changes in respiratory muscle strength
timeFrame: Post-intervention (12 weeks)
measure: Changes in physical activity
timeFrame: Post-intervention (12 weeks)
measure: Attendance
timeFrame: Post-intervention (12 weeks)
measure: Exercise tolerability
timeFrame: Post-intervention (12 weeks)
measure: Changes in muscle mass
timeFrame: 1 month post-KT
measure: Changes in mood state
timeFrame: Through study completion, an average of 1 year
measure: Changes in health-related quality of life
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalonia
Study officials:
affiliation: Parc de Salut Mar
name: Julio Pascual Santos
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.