S&F4NTx: Smart and Fit for Kidney Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise |
Behavioral: intensive 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.)
|
| Active Comparator: Control usual care App-assisted |
Behavioral: Usual Care
Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Six-Minutes-Walk test (6MWT) [6 and 12 month]
measured in distance (meter)
- Sit-to-stand test (STS60) [6 and 12 month]
measured in number of repetitions in 60 seconds
- 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
- 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)
- One-Legged Stance Test [6 and 12 month]
measured in time (seconds)
- Stair Climb Test [6 and 12 month]
measured in time (seconds)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Erlangen | Erlangen | Bavaria | Germany | 91054 |
Sponsors and Collaborators
- University of Erlangen-Nürnberg Medical School
- m&i Fachklinik Bad Heilbrunn
- m&i-Fachklinik Herzogenaurach
- Carealytix Digital Health GmbH
Investigators
- Study Director: Mario Schiffer, Prof., Universitätsklinikum Erlangen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GE8-2496-IMV-2019-V2