Smart and Fit for Kidney Transplantation (S&F4NTx)

The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Intervention / Treatment: Behavioral: intensive individual support in nutrition and exercise; Behavioral: Usual Care

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helge Krusemark; Phone Number: +4991318542966; Email: helge.krusemark@uk-erlangen.de
• Study Contact Backup: Name: Judith Kleemann; Phone Number: +4991318543086; Email: judith.kleemann@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Universitatsklinikum Erlangen
      • Contact: Mario Schiffer, Prof.; Phone Number: +4991318539002; Email: mario.schiffer@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise	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.)
Active Comparator: Control; usual care App-assisted	Behavioral: Usual Care; Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle mass	measured in kg by bio-impedance analysis	6 and 12 month
body fat mass	measured in kg by bio-impedance analysis	6 and 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-Minutes-Walk test (6MWT)	measured in distance (meter)	6 and 12 month
Sit-to-stand test (STS60)	measured in number of repetitions in 60 seconds	6 and 12 month
Timed-up-and-go test (TUG)	measured in time (seconds)	6 and 12 month
One-Legged Stance Test	measured in time (seconds)	6 and 12 month
Stair Climb Test	measured in time (seconds)	6 and 12 month
Quality of life by Short Form Health Survey (SF-12)	measured in change of scale by questionnaire	6 and 12 month
Fried Frailty Scale	measured in change of score (score of 0 = not frail; score of 1-2 = pre-frail; score of 3-5 = frail)	6 and 12 month

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: m&i Fachklinik Bad Heilbrunn; Carealytix Digital Health GmbH
• Investigators: Study Director: Mario Schiffer, Prof., Universitatsklinikum Erlangen

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Transplantation; Prehabilitation; Exercise and Nutritional Support
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: GE8-2496-IMV-2019-V2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No