xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040281</url>
    </required_header>
    <id_info>
      <org_study_id>GE8-2496-IMV-2019-V2</org_study_id>
      <nct_id>NCT06040281</nct_id>
    </id_info>
    <brief_title>Smart and Fit for Kidney Transplantation</brief_title>
    <acronym>S&amp;F4NTx</acronym>
    <official_title>The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: A Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Erlangen-Nürnberg Medical School</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>m&amp;i Fachklinik Bad Heilbrunn</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>m&amp;i-Fachklinik Herzogenaurach</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Carealytix Digital Health GmbH</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Erlangen-Nürnberg Medical School</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a randomised controlled intervention trial for patients with chronic kidney&#xD;
        disease who are on the waiting list for a kidney transplantation (n=200). The aim of this&#xD;
        study is to test the effectiveness of intensive individual nutritional and exercise support&#xD;
        combined with comprehensive rehabilitation before transplantation in comparison to a control&#xD;
        group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients are randomised to either the intervention or control group at the beginning of the&#xD;
        study. Both groups are evaluated at the beginning after 6 months and after 12 months&#xD;
        regarding their body composition, physical performance, blood values, quality of life and&#xD;
        nutritional status. The control group only receives support via app during the study period&#xD;
        (1 year), through which they receive detailed information about dialysis. In addition to&#xD;
        access to the app, the intervention group receives individual recommendations for nutrition&#xD;
        and exercise as well as a three-week inpatient rehabilitation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>muscle mass</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in kg by bio-impedance analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>body fat mass</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in kg by bio-impedance analysis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Six-Minutes-Walk test (6MWT)</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in distance (meter)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sit-to-stand test (STS60)</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in number of repetitions in 60 seconds</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timed-up-and-go test (TUG)</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in time (seconds)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life by Short Form Health Survey (SF-12)</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in change of scale by questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fried Frailty Scale</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in change of score (score of 0 = not frail; score of 1-2 = pre-frail; score of 3-5 = frail)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One-Legged Stance Test</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in time (seconds)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stair Climb Test</measure>
      <time_frame>6 and 12 month</time_frame>
      <description>measured in time (seconds)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Chronic Kidney Disease Requiring Chronic Dialysis</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>usual care App-assisted</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>intensive individual support in nutrition and exercise</intervention_name>
      <description>Intensive care for nutrition and exercise adapted to the social context. Individualised exercise and nutrition recommendations.&#xD;
  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.)</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must be on dialysis&#xD;
  &#xD;
            -  Patients ≥ 18 years of age&#xD;
  &#xD;
            -  Patients who own a smartphone&#xD;
  &#xD;
            -  Patients must be willing to undergo inpatient rehabilitation within the project period&#xD;
  &#xD;
            -  signed informed consent and data protection regulation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are not psychologically or physically able to take part in exercise&#xD;
               promotion measures and/or nutritional counselling as well as psychological offers&#xD;
  &#xD;
            -  Patients who have already participated in a similar project&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mario Schiffer, Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Universitätsklinikum Erlangen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Helge Krusemark</last_name>
      <phone>+4991318542966</phone>
      <email>helge.krusemark@uk-erlangen.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Judith Kleemann</last_name>
      <phone>+4991318543086</phone>
      <email>judith.kleemann@uk-erlangen.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Universitätsklinikum Erlangen</name>
        <address>
          <city>Erlangen</city>
          <state>Bavaria</state>
          <zip>91054</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Schiffer, Prof.</last_name>
        <phone>+4991318539002</phone>
        <email>mario.schiffer@uk-erlangen.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Transplantation</keyword>
    <keyword>Prehabilitation</keyword>
    <keyword>Exercise and Nutritional Support</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040281
  org study id: GE8-2496-IMV-2019-V2
  nct id: NCT06040281
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  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)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: muscle mass
  time frame: 6 and 12 month
  description: measured in kg by bio-impedance analysis
  measure: body fat mass
  time frame: 6 and 12 month
  description: measured in kg by bio-impedance analysis
  measure: Six-Minutes-Walk test (6MWT)
  time frame: 6 and 12 month
  description: measured in distance (meter)
  measure: Sit-to-stand test (STS60)
  time frame: 6 and 12 month
  description: measured in number of repetitions in 60 seconds
  measure: Timed-up-and-go test (TUG)
  time frame: 6 and 12 month
  description: measured in time (seconds)
  measure: Quality of life by Short Form Health Survey (SF-12)
  time frame: 6 and 12 month
  description: measured in change of scale by questionnaire
  measure: Fried Frailty Scale
  time frame: 6 and 12 month
  description: measured in change of score (score of 0 = not frail; score of 1-2 = pre-frail; score of 3-5 = frail)
  measure: One-Legged Stance Test
  time frame: 6 and 12 month
  description: measured in time (seconds)
  measure: Stair Climb Test
  time frame: 6 and 12 month
  description: measured in time (seconds)
  arm group label: Intervention
  arm group type: Experimental
  description: App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise
  arm group label: Control
  arm group type: Active Comparator
  description: usual care App-assisted
  intervention type: Behavioral
  intervention name: intensive individual support in nutrition and exercise
  description: 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.)
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Usual Care
  description: Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mario Schiffer, Prof.
  role: Study Director
  affiliation: Universitätsklinikum Erlangen
  last name: Helge Krusemark
  phone: +4991318542966
  email: helge.krusemark@uk-erlangen.de
  last name: Judith Kleemann
  phone: +4991318543086
  email: judith.kleemann@uk-erlangen.de
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic