NCT06040281

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 30, 2025

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

September 8, 2023

Last Update Submit

March 25, 2025

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

TransplantationPrehabilitationExercise and Nutritional Support

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Six-Minutes-Walk test (6MWT)

    6 and 12 month

  • Sit-to-stand test (STS60)

    6 and 12 month

  • Timed-up-and-go test (TUG)

    6 and 12 month

  • Quality of life by Short Form Health Survey (SF-12)

    6 and 12 month

  • Fried Frailty Scale

    6 and 12 month

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: intensive individual support in nutrition and exercise

Control

ACTIVE COMPARATOR

usual care App-assisted

Behavioral: Usual Care

Interventions

intensive individual support in nutrition and exerciseBEHAVIORAL

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
Usual CareBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40841967DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Nutritional StatusExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mario Schiffer, Prof.

    Universitätsklinikum Erlangen

    STUDY DIRECTOR

Central Study Contacts

Helge Krusemark

CONTACT

+4991318542966helge.krusemark@uk-erlangen.de

Judith Kleemann

CONTACT

+4991318543086judith.kleemann@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 15, 2023

Study Start

September 18, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

March 30, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)