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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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 App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
RECRUITINGmuscle mass
measured in kg by bio-impedance analysis
Time frame: 6 and 12 month
body fat mass
measured in kg by bio-impedance analysis
Time frame: 6 and 12 month
Six-Minutes-Walk test (6MWT)
measured in distance (meter)
Time frame: 6 and 12 month
Sit-to-stand test (STS60)
measured in number of repetitions in 60 seconds
Time frame: 6 and 12 month
Timed-up-and-go test (TUG)
measured in time (seconds)
Time frame: 6 and 12 month
Quality of life by Short Form Health Survey (SF-12)
measured in change of scale by questionnaire
Time frame: 6 and 12 month
Fried Frailty Scale
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
One-Legged Stance Test
measured in time (seconds)
Time frame: 6 and 12 month
Stair Climb Test
measured in time (seconds)
Time frame: 6 and 12 month
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