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Smart and Fit for Kidney Transplantation (S&F4NTx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06040281
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : October 5, 2023
Sponsor:
Collaborators:
m&i Fachklinik Bad Heilbrunn
m&i-Fachklinik Herzogenaurach
Carealytix Digital Health GmbH
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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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
Chronic Kidney Disease Requiring Chronic Dialysis Behavioral: intensive individual support in nutrition and exercise Behavioral: Usual Care Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: A Randomised Controlled Trial
Actual Study Start Date : September 18, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. muscle mass [ Time Frame: 6 and 12 month ]
    measured in kg by bio-impedance analysis

  2. body fat mass [ Time Frame: 6 and 12 month ]
    measured in kg by bio-impedance analysis


Secondary Outcome Measures :
  1. Six-Minutes-Walk test (6MWT) [ Time Frame: 6 and 12 month ]
    measured in distance (meter)

  2. Sit-to-stand test (STS60) [ Time Frame: 6 and 12 month ]
    measured in number of repetitions in 60 seconds

  3. Timed-up-and-go test (TUG) [ Time Frame: 6 and 12 month ]
    measured in time (seconds)

  4. Quality of life by Short Form Health Survey (SF-12) [ Time Frame: 6 and 12 month ]
    measured in change of scale by questionnaire

  5. Fried Frailty Scale [ Time Frame: 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)

  6. One-Legged Stance Test [ Time Frame: 6 and 12 month ]
    measured in time (seconds)

  7. Stair Climb Test [ Time Frame: 6 and 12 month ]
    measured in time (seconds)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040281


Contacts
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Contact: Helge Krusemark +4991318542966 helge.krusemark@uk-erlangen.de
Contact: Judith Kleemann +4991318543086 judith.kleemann@uk-erlangen.de

Locations
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Germany
Universitätsklinikum Erlangen Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Mario Schiffer, Prof.    +4991318539002    mario.schiffer@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
m&i Fachklinik Bad Heilbrunn
m&i-Fachklinik Herzogenaurach
Carealytix Digital Health GmbH
Investigators
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Study Director: Mario Schiffer, Prof. Universitätsklinikum Erlangen
More Information
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT06040281    
Other Study ID Numbers: GE8-2496-IMV-2019-V2
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: October 5, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Transplantation
Prehabilitation
Exercise and Nutritional Support
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes