Chronic Kidney Diseases
Conditions
Keywords
chronic kidney disease, kidney transplantation, frailty, prehabilitation, exercise, nutritional status, psychological advice, sarcopenia
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.
Interventions
OTHERMultimodal prehabilitation
Exercise + nutritional supplementation + psychological advice
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bad-Outcome Composite Endpoint | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in peripheral muscle strength | Post-intervention (12 weeks) | Changes in handgrip and quadriceps muscles strength (higher scores mean better outcome) |
| Changes in respiratory muscle strength | Post-intervention (12 weeks) | Changes in maximal inspiratory and expiratory muscle strength (higher scores mean better outcome) |
| Changes in physical activity | Post-intervention (12 weeks) | Changes in physical activity assessed by activity monitors (higher scores mean better outcome) |
| Attendance | Post-intervention (12 weeks) | Attended sessions (0-100%, patients are expected to attend a minimum of 80% sessions) |
| Changes in exercise capacity | Post-intervention (12 weeks) | Changes in peak oxygen uptake (higher scores mean better outcome) |
| Changes in muscle mass | 1 month post-KT | Changes in muscle mass assessed with total body dual energy X-ray |
| Changes in mood state | Through study completion, an average of 1 year | Changes in Hospital Anxiety Depression Scale |
| Changes in health-related quality of life | 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) |
| Exercise tolerability | Post-intervention (12 weeks) | Patients not requiring exercise discontinuation or intensity modification |
Countries
Spain
Contacts
Primary ContactEster Marco, MD
Outcome results
None listed