Chronic Kidney Diseases Clinical Trial
— FrailmarOfficial title:
Frailty in Patients With Advanced Chronic Kidney Disease Waiting for a Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation.
Verified date | May 2023 |
Source | Parc de Salut Mar |
Contact | Ester Marco, MD |
Phone | +34699706860 |
emarco[@]psmar.cat | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Changes in exercise capacity | Changes in peak oxygen uptake (higher scores mean better outcome) | Post-intervention (12 weeks) | |
Secondary | Changes in peripheral muscle strength | Changes in handgrip and quadriceps muscles strength (higher scores mean better outcome) | Post-intervention (12 weeks) | |
Secondary | Changes in respiratory muscle strength | Changes in maximal inspiratory and expiratory muscle strength (higher scores mean better outcome) | Post-intervention (12 weeks) | |
Secondary | Changes in physical activity | Changes in physical activity assessed by activity monitors (higher scores mean better outcome) | Post-intervention (12 weeks) | |
Secondary | Attendance | Attended sessions (0-100%, patients are expected to attend a minimum of 80% sessions) | Post-intervention (12 weeks) | |
Secondary | Exercise tolerability | Patients not requiring exercise discontinuation or intensity modification | Post-intervention (12 weeks) | |
Secondary | Changes in muscle mass | Changes in muscle mass assessed with total body dual energy X-ray | 1 month post-KT | |
Secondary | Changes in mood state | Changes in Hospital Anxiety Depression Scale | Through study completion, an average of 1 year | |
Secondary | 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 |
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