Smart and Fit for Kidney Transplantation

NCT ID: NCT06040281

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random assignment in 1:1 ratio to either the intervention group (app-assisted, individual support in nutrition and exercise, three-week comprehensive rehabilitation) or control group (Usual care and app-assisted)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise

Group Type EXPERIMENTAL

intensive individual support in nutrition and exercise

Intervention Type BEHAVIORAL

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.)

Control

usual care App-assisted

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)

Interventions

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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.)

Intervention Type BEHAVIORAL

Usual Care

Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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m&i Fachklinik Bad Heilbrunn

UNKNOWN

Sponsor Role collaborator

Carealytix Digital Health GmbH

UNKNOWN

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mario Schiffer, Prof.

Role: STUDY_DIRECTOR

Universitätsklinikum Erlangen

Locations

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Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Helge Krusemark

Role: CONTACT

+4991318542966

Judith Kleemann

Role: CONTACT

+4991318543086

Facility Contacts

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Mario Schiffer, Prof.

Role: primary

+4991318539002

References

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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.

Reference Type DERIVED
PMID: 40841967 (View on PubMed)

Other Identifiers

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GE8-2496-IMV-2019-V2

Identifier Type: -

Identifier Source: org_study_id

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