Smart and Fit for Kidney Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intensive individual support in nutrition and exercise, Usual Care.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease Requiring Chronic Dialysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial
Overview
This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.
Detailed description
Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning after 6 months and after 12 months regarding their body composition, physical performance, blood values, quality of life and nutritional status. The control group only receives support via app during the study period (1 year), through which they receive detailed information about dialysis. In addition to access to the app, the intervention group receives individual recommendations for nutrition and exercise as well as a three-week inpatient rehabilitation.
Interventions
- Behavioral intensive individual support in nutrition and exercise
Intensive care for nutrition and exercise adapted to the social context. Individualised exercise and nutrition recommendations. three weeks of inpatient rehabilitation with an individual plan of treatment, which includes medical care, sports therapy, physiotherapy, ergotherapy, nutritional education and psychological care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.) - Behavioral Usual Care
Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
Primary outcome measures
- muscle mass [Time frame: 6 and 12 month]
- body fat mass [Time frame: 6 and 12 month]
Secondary outcome measures (7)
- Six-Minutes-Walk test (6MWT) [Time frame: 6 and 12 month]
- Sit-to-stand test (STS60) [Time frame: 6 and 12 month]
- Timed-up-and-go test (TUG) [Time frame: 6 and 12 month]
- Quality of life by Short Form Health Survey (SF-12) [Time frame: 6 and 12 month]
- Fried Frailty Scale [Time frame: 6 and 12 month]
- One-Legged Stance Test [Time frame: 6 and 12 month]
- Stair Climb Test [Time frame: 6 and 12 month]
Eligibility criteria
Inclusion criteria
- Patients must be on dialysis
- Patients ≥ 18 years of age
- Patients who own a smartphone
- Patients must be willing to undergo inpatient rehabilitation within the project period
- signed informed consent and data protection regulation
Exclusion criteria
- Patients who are not psychologically or physically able to take part in exercise promotion measures and/or nutritional counselling as well as psychological offers
- Patients who have already participated in a similar project
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Universitätsklinikum Erlangen — Erlangen
Publications
- Krusemark H, Kleemann J, Weigand J, Kannenkeril D, Heller K, Hepp T, Albersmeyer M, Gerbig D, Schiffer M. A randomized, controlled, 12-month trial on the effects of an interdisciplinary treatment approach in ESRD patients: study protocol of the smart and fit for kidney transplantation trial (S&F4KTx). Trials. 2025 Aug 21;26(1):298. doi: 10.1186/s13063-025-09022-2. PMID 40841967
Identifiers
NCT: NCT06040281 · GE8-2496-IMV-2019-V2