Trials / Recruiting
RecruitingNCT06040281
Smart and Fit for Kidney Transplantation
The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- University of Erlangen-Nürnberg Medical School · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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.) |
| BEHAVIORAL | Usual Care | Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.) |
Timeline
- Start date
- 2023-09-18
- Primary completion
- 2026-03-31
- Completion
- 2026-03-31
- First posted
- 2023-09-15
- Last updated
- 2025-03-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06040281. Inclusion in this directory is not an endorsement.