Clinical trial NCT06040281: Smart and Fit for Kidney Transplantation
Official title: The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: Transplantation
Prehabilitation
Exercise and Nutritional Support
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: m&i Fachklinik Bad Heilbrunn
name: Carealytix Digital Health GmbH
First posted: 2023-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: muscle mass
timeFrame: 6 and 12 month
measure: body fat mass
timeFrame: 6 and 12 month
Secondary outcomes:
measure: Six-Minutes-Walk test (6MWT)
timeFrame: 6 and 12 month
measure: Sit-to-stand test (STS60)
timeFrame: 6 and 12 month
measure: Timed-up-and-go test (TUG)
timeFrame: 6 and 12 month
measure: Quality of life by Short Form Health Survey (SF-12)
timeFrame: 6 and 12 month
measure: Fried Frailty Scale
timeFrame: 6 and 12 month
measure: One-Legged Stance Test
timeFrame: 6 and 12 month
measure: Stair Climb Test
timeFrame: 6 and 12 month
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bavaria
Study officials:
affiliation: Universitätsklinikum Erlangen
name: Mario Schiffer, Prof.
role: STUDY_DIRECTOR
References: