Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT06040281
Smart and Fit for Kidney Transplantation
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
intensive individual support in nutrition and exercise
BehavioralIntensive 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.)
Usual Care
BehavioralUsual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
Primary outcomes
-
muscle mass
Time frame: 6 and 12 month
measured in kg by bio-impedance analysis
-
body fat mass
Time frame: 6 and 12 month
measured in kg by bio-impedance analysis
Secondary outcomes
-
Six-Minutes-Walk test (6MWT)
Time frame: 6 and 12 month
measured in distance (meter)
-
Sit-to-stand test (STS60)
Time frame: 6 and 12 month
measured in number of repetitions in 60 seconds
-
Timed-up-and-go test (TUG)
Time frame: 6 and 12 month
measured in time (seconds)
-
Quality of life by Short Form Health Survey (SF-12)
Time frame: 6 and 12 month
measured in change of scale by questionnaire
-
Fried Frailty Scale
Time frame: 6 and 12 month
measured in change of score (score of 0 = not frail; score of 1-2 = pre-frail; score of 3-5 = frail)
-
One-Legged Stance Test
Time frame: 6 and 12 month
measured in time (seconds)
-
Stair Climb Test
Time frame: 6 and 12 month
measured in time (seconds)
Study contacts
Contact information is provided by the study sponsor or research team.
Helge Krusemark
CONTACT
Judith Kleemann
CONTACT
Sponsors and collaborators
Lead sponsor
University of Erlangen-Nürnberg Medical School
Other
Collaborators
- Carealytix Digital Health GmbH
- m&i Fachklinik Bad Heilbrunn
Registry information
Official study title
The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial
Acronym: S&F4NTx
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 15, 2023
- Registry last updated
- Mar 30, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
NCT06712654
Chronic Kidney Disease Requiring Chronic Dialysis, End Stage Renal Disease on Dialysis
Huntsville, Alabama, United States
View Trial Details
Recruiting
Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients
NCT07710183
Chronic Disease, Chronic Kidney Disease Requiring Chronic Dialysis
Baghdad, Karkh, Iraq
View Trial Details
Recruiting
Fluid Intake After Hemodialysis
NCT04721652
Chronic Kidney Disease Requiring Chronic Dialysis, Interdialytic Weight Gain
London, Ontario, Canada
View Trial Details
Recruiting
Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
NCT06635525
Chronic Disease, Chronic Kidney Disease Requiring Chronic Dialysis
Milan, Italy
View Trial Details