Chronic Kidney Disease Requiring Chronic Dialysis
Conditions
Keywords
Transplantation, Prehabilitation, Exercise and Nutritional Support
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.
Interventions
BEHAVIORALintensive 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.)
BEHAVIORALUsual Care
Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
Sponsors
m&i Fachklinik Bad Heilbrunn
Carealytix Digital Health GmbH
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle mass | 6 and 12 month | measured in kg by bio-impedance analysis |
| body fat mass | 6 and 12 month | measured in kg by bio-impedance analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed-up-and-go test (TUG) | 6 and 12 month | measured in time (seconds) |
| Quality of life by Short Form Health Survey (SF-12) | 6 and 12 month | measured in change of scale by questionnaire |
| Six-Minutes-Walk test (6MWT) | 6 and 12 month | measured in distance (meter) |
| One-Legged Stance Test | 6 and 12 month | measured in time (seconds) |
| Stair Climb Test | 6 and 12 month | measured in time (seconds) |
| Fried Frailty Scale | 6 and 12 month | measured in change of score (score of 0 = not frail; score of 1-2 = pre-frail; score of 3-5 = frail) |
| Sit-to-stand test (STS60) | 6 and 12 month | measured in number of repetitions in 60 seconds |
Countries
Germany
Contacts
Primary ContactHelge Krusemark
Backup ContactJudith Kleemann
Outcome results
None listed