Smart and Fit for Kidney Transplantation (S&F4NTx)

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Behavioral: Usual Care; Behavioral: intensive individual support in nutrition and exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06040281

GE8-2496-IMV-2019-V2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: intensive individual support in nutrition and exercise

Control

Active Comparator group

Description:

usual care App-assisted

Treatment:

Behavioral: Usual Care