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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal intervention | Experimental | supervised physical training (1-hour sessions, 24 sessions, 8 weeks) + nutritional supplementation + psychological advice |
|
| Standard Care | No Intervention | Healthy living recommendations |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal prehabilitation | Other | Exercise + nutritional supplementation + psychological advice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in exercise capacity | Changes in peak oxygen uptake (higher scores mean better outcome) | Post-intervention (12 weeks) |
| Changes in peripheral muscle strength | Changes in handgrip and quadriceps muscles strength (higher scores mean better outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ester Marco, MD | Contact | +34699706860 | emarco@psmar.cat |
| Name | Affiliation | Role |
|---|---|---|
| Julio Pascual Santos | Parc de Salut Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Recruiting | Barcelona | Catalonia | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40816623 | Derived | 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. | |
| 34095178 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000073496 | Frailty |
| D009043 | Motor Activity |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Randomized Clinical Trial
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| Post-intervention (12 weeks) |
| Changes in respiratory muscle strength | Changes in maximal inspiratory and expiratory muscle strength (higher scores mean better outcome) | Post-intervention (12 weeks) |
| Changes in physical activity | Changes in physical activity assessed by activity monitors (higher scores mean better outcome) | Post-intervention (12 weeks) |
| Attendance | Attended sessions (0-100%, patients are expected to attend a minimum of 80% sessions) | Post-intervention (12 weeks) |
| Exercise tolerability | Patients not requiring exercise discontinuation or intensity modification | Post-intervention (12 weeks) |
| Changes in muscle mass | Changes in muscle mass assessed with total body dual energy X-ray | 1 month post-KT |
| Changes in mood state | Changes in Hospital Anxiety Depression Scale | Through study completion, an average of 1 year |
| Changes in health-related quality of life | 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 |
| 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |