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Smart and Fit for Kidney Transplantation (S&F4NTx)

Primary Purpose

Chronic Kidney Disease Requiring Chronic Dialysis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intensive individual support in nutrition and exercise
Usual Care
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Requiring Chronic Dialysis focused on measuring Transplantation, Prehabilitation, Exercise and Nutritional Support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum ErlangenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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

usual care App-assisted

Outcomes

Primary Outcome Measures

muscle mass
measured in kg by bio-impedance analysis
body fat mass
measured in kg by bio-impedance analysis

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2023
Last Updated
October 4, 2023
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
m&i Fachklinik Bad Heilbrunn, m&i-Fachklinik Herzogenaurach, Carealytix Digital Health GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT06040281
Brief Title
Smart and Fit for Kidney Transplantation
Acronym
S&F4NTx
Official Title
The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
m&i Fachklinik Bad Heilbrunn, m&i-Fachklinik Herzogenaurach, Carealytix Digital Health GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Requiring Chronic Dialysis
Keywords
Transplantation, Prehabilitation, Exercise and Nutritional Support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise
Arm Title
Control
Arm Type
Active Comparator
Arm Description
usual care App-assisted
Intervention Type
Behavioral
Intervention Name(s)
intensive individual support in nutrition and exercise
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
Primary Outcome Measure Information:
Title
muscle mass
Description
measured in kg by bio-impedance analysis
Time Frame
6 and 12 month
Title
body fat mass
Description
measured in kg by bio-impedance analysis
Time Frame
6 and 12 month
Secondary Outcome Measure Information:
Title
Six-Minutes-Walk test (6MWT)
Description
measured in distance (meter)
Time Frame
6 and 12 month
Title
Sit-to-stand test (STS60)
Description
measured in number of repetitions in 60 seconds
Time Frame
6 and 12 month
Title
Timed-up-and-go test (TUG)
Description
measured in time (seconds)
Time Frame
6 and 12 month
Title
Quality of life by Short Form Health Survey (SF-12)
Description
measured in change of scale by questionnaire
Time Frame
6 and 12 month
Title
Fried Frailty Scale
Description
measured in change of score (score of 0 = not frail; score of 1-2 = pre-frail; score of 3-5 = frail)
Time Frame
6 and 12 month
Title
One-Legged Stance Test
Description
measured in time (seconds)
Time Frame
6 and 12 month
Title
Stair Climb Test
Description
measured in time (seconds)
Time Frame
6 and 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helge Krusemark
Phone
+4991318542966
Email
helge.krusemark@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Kleemann
Phone
+4991318543086
Email
judith.kleemann@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Schiffer, Prof.
Organizational Affiliation
Universitätsklinikum Erlangen
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Schiffer, Prof.
Phone
+4991318539002
Email
mario.schiffer@uk-erlangen.de

12. IPD Sharing Statement

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Smart and Fit for Kidney Transplantation

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