Smart and Fit for Kidney Transplantation

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

— S&F4NTx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040281
• Other study ID #: GE8-2496-IMV-2019-V2
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Helge Krusemark
• Phone: +4991318542966
• Email: helge.krusemark[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen	Erlangen	Bavaria

Sponsors (4)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Carealytix Digital Health GmbH, m&i Fachklinik Bad Heilbrunn, m&i-Fachklinik Herzogenaurach

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle mass	measured in kg by bio-impedance analysis	6 and 12 month
Primary	body fat mass	measured in kg by bio-impedance analysis	6 and 12 month
Secondary	Six-Minutes-Walk test (6MWT)	measured in distance (meter)	6 and 12 month
Secondary	Sit-to-stand test (STS60)	measured in number of repetitions in 60 seconds	6 and 12 month
Secondary	Timed-up-and-go test (TUG)	measured in time (seconds)	6 and 12 month
Secondary	Quality of life by Short Form Health Survey (SF-12)	measured in change of scale by questionnaire	6 and 12 month
Secondary	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
Secondary	One-Legged Stance Test	measured in time (seconds)	6 and 12 month
Secondary	Stair Climb Test	measured in time (seconds)	6 and 12 month