Smart and Fit for Kidney Transplantation

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

• Registration Number: NCT06040281
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Start: 2023-09-18
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
muscle mass	6 and 12 month	measured in kg by bio-impedance analysis
body fat mass	6 and 12 month	measured in kg by bio-impedance analysis

Secondary Outcome Measures

Name	Time	Method
Timed-up-and-go test (TUG)	6 and 12 month	measured in time (seconds)
One-Legged Stance Test	6 and 12 month	measured in time (seconds)
Stair Climb Test	6 and 12 month	measured in time (seconds)
Quality of life by Short Form Health Survey (SF-12)	6 and 12 month	measured in change of scale by questionnaire
Sit-to-stand test (STS60)	6 and 12 month	measured in number of repetitions in 60 seconds
Fried Frailty Scale	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)
Six-Minutes-Walk test (6MWT)	6 and 12 month	measured in distance (meter)

Trial Locations

Locations (1)

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Bavaria, Germany