Smart and Fit for Kidney Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
intensive individual support in nutrition and exercise
BehavioralIntensive 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
BehavioralUsual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
muscle mass
measured in kg by bio-impedance analysis
Time frame
6 and 12 month2
body fat mass
measured in kg by bio-impedance analysis
Time frame
6 and 12 monthSecondary outcomes
1
Six-Minutes-Walk test (6MWT)
measured in distance (meter)
Time frame
6 and 12 month2
Sit-to-stand test (STS60)
measured in number of repetitions in 60 seconds
Time frame
6 and 12 month3
Timed-up-and-go test (TUG)
measured in time (seconds)
Time frame
6 and 12 month4
Quality of life by Short Form Health Survey (SF-12)
measured in change of scale by questionnaire
Time frame
6 and 12 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Erlangen-Nürnberg Medical School
Lead sponsor
m&i Fachklinik Bad Heilbrunn
Collaborator
Carealytix Digital Health GmbH
Collaborator
Source ClinicalTrials.gov