Smart and Fit for Kidney Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: A Randomised Controlled Trial

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Behavioral: intensive individual support in nutrition and exercise
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise | Behavioral: intensive individual support in nutrition and exercise<br>* 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.)<br>|
| Active Comparator: Control<br>usual care App-assisted | Behavioral: Usual Care<br>* Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass | measured in kg by bio-impedance analysis | 6 and 12 month | 
| body fat mass | measured in kg by bio-impedance analysis | 6 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minutes-Walk test (6MWT) | measured in distance (meter) | 6 and 12 month | 
| Sit-to-stand test (STS60) | measured in number of repetitions in 60 seconds | 6 and 12 month | 
| Timed-up-and-go test (TUG) | measured in time (seconds) | 6 and 12 month | 
| Quality of life by Short Form Health Survey (SF-12) | measured in change of scale by questionnaire | 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) | 6 and 12 month | 
| One-Legged Stance Test | measured in time (seconds) | 6 and 12 month | 
| Stair Climb Test | measured in time (seconds) | 6 and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation, Prehabilitation, Exercise and Nutritional Support