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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

Tracking Information
First Submitted Date  ICMJE September 8, 2023
First Posted Date  ICMJE September 15, 2023
Last Update Posted Date October 5, 2023
Actual Study Start Date  ICMJE September 18, 2023
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2023)
  • muscle mass [ Time Frame: 6 and 12 month ]
    measured in kg by bio-impedance analysis
  • body fat mass [ Time Frame: 6 and 12 month ]
    measured in kg by bio-impedance analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2023)
  • Six-Minutes-Walk test (6MWT) [ Time Frame: 6 and 12 month ]
    measured in distance (meter)
  • Sit-to-stand test (STS60) [ Time Frame: 6 and 12 month ]
    measured in number of repetitions in 60 seconds
  • Timed-up-and-go test (TUG) [ Time Frame: 6 and 12 month ]
    measured in time (seconds)
  • Quality of life by Short Form Health Survey (SF-12) [ Time Frame: 6 and 12 month ]
    measured in change of scale by questionnaire
  • 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)
  • One-Legged Stance Test [ Time Frame: 6 and 12 month ]
    measured in time (seconds)
  • Stair Climb Test [ Time Frame: 6 and 12 month ]
    measured in time (seconds)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2023)
  • Six-Minutes-Walk test (6MWT) [ Time Frame: 6 and 12 month ]
    measured in distance (meter)
  • Sit-to-stand test (STS60) [ Time Frame: 6 and 12 month ]
    measured in number of repetitions in 60 seconds
  • Timed-up-and-go test (TUG) [ Time Frame: 6 and 12 month ]
    measured in time (seconds)
  • Quality of life by SF-12 [ Time Frame: 6 and 12 month ]
    measured in change of scale by questionnaire
  • Fried Frailty Scale [ Time Frame: 6 and 12 month ]
    measured in change of score
  • One-Legged Stance Test [ Time Frame: 6 and 12 month ]
    measured in time (seconds)
  • Stair Climb Test [ Time Frame: 6 and 12 month ]
    measured in time (seconds)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smart and Fit for Kidney Transplantation
Official Title  ICMJE The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: A Randomised Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Chronic Kidney Disease Requiring Chronic Dialysis
Intervention  ICMJE
  • 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.)
Study Arms  ICMJE
  • Experimental: Intervention
    App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise
    Intervention: Behavioral: intensive individual support in nutrition and exercise
  • Active Comparator: Control
    usual care App-assisted
    Intervention: Behavioral: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2023)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Helge Krusemark +4991318542966 helge.krusemark@uk-erlangen.de
Contact: Judith Kleemann +4991318543086 judith.kleemann@uk-erlangen.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06040281
Other Study ID Numbers  ICMJE GE8-2496-IMV-2019-V2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Erlangen-Nürnberg Medical School
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • m&i Fachklinik Bad Heilbrunn
  • m&i-Fachklinik Herzogenaurach
  • Carealytix Digital Health GmbH
Investigators  ICMJE
Study Director: Mario Schiffer, Prof. Universitätsklinikum Erlangen
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP