Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06040281

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

Led by University of Erlangen-Nürnberg Medical School · Updated on 2025-03-30

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Erlangen-Nürnberg Medical School

Lead Sponsor

M

m&i Fachklinik Bad Heilbrunn

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an intervention for patients with chronic kidney disease who are on the waiting list for a kidney transplant. This randomized controlled trial aims to test whether intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation is more effective than usual care. The study involves 200 patients and is sponsored by the University of Erlangen-Nürnberg Medical School. Participants are randomly assigned to one of two groups. The intervention group receives individualized recommendations on nutrition and exercise, access to an app with detailed dialysis information, and a three-week inpatient rehabilitation program that includes medical care, sports therapy, physiotherapy, occupational therapy, nutritional education, and psychological support. The control group receives usual care, which includes app access for dialysis information but no additional personalized support or rehabilitation. Both groups are followed for one year. Participants are assessed at the start of the study, after 6 months, and after 12 months. Researchers measure body composition, including muscle mass and body fat mass, physical performance through tests such as the Six-Minutes-Walk test, Sit-to-stand test, Timed-up-and-go test, and others. Quality of life, nutritional status, and frailty are also evaluated. The study monitors these outcomes to understand the impact of the intervention compared to usual care over the one-year period.

CONDITIONS

Brief Title

Smart and Fit for Kidney Transplantation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be on dialysis
  • Patients 18 years of age or older
  • Patients who own a smartphone
  • Patients must be willing to undergo inpatient rehabilitation within the project period
  • Signed informed consent and data protection regulation
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 year

Participants are randomized to either receive usual care with app support or an intervention including app support plus individual nutrition and exercise recommendations and a three-week inpatient rehabilitation.

1 baseline visit, 1 three-week inpatient rehabilitation period for intervention group, and follow-up visits at 6 and 12 months

Trial Site Locations

Total: 1 location

1

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany, 91054

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Research Team

H

Helge Krusemark

J

Judith Kleemann

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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).

Helge Krusemark, Judith Kleemann, Julian Weigand...

https://pubmed.ncbi.nlm.nih.gov/40841967