<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/NCT04461301</url>
  </required_header>
  <id_info>
    <org_study_id>PREHAB2020</org_study_id>
    <nct_id>NCT04461301</nct_id>
  </id_info>
  <brief_title>Multimodal Prehabilitation for Surgery in the Elderly: A Randomised, Prospective, Multicenter, Multidisciplinary Trial</brief_title>
  <acronym>PREHABIL</acronym>
  <official_title>Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: A Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</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 multicentric, randomised controlled trial is to the investigators knowledge the first&#xD;
      implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge&#xD;
      from different specialties to lower complications and to increase cost effectiveness after&#xD;
      major surgery in elderly, frail patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative complications occur in up to 50% of patients and major surgery is associated&#xD;
      with a 20 to 40% reduction in physiological and functional capacity. The elderly have surgery&#xD;
      4 times more often than the rest of the population, thus in the future a major proportion of&#xD;
      patients presenting for surgery will be older than 65 years. Elderly patients have more&#xD;
      postoperative complications, a longer convalescence and higher surgical morbidity and&#xD;
      mortality. The number and severity of complications are closely related to preoperative&#xD;
      functional capacity, nutritional state, psychological state, and smoking behavior. Another&#xD;
      population most probably to benefit from such a program are cancer patients with decreased&#xD;
      functional health after cancer treatment. Cancer prehabilitation affords an opportunity for&#xD;
      the patient to improve functional status while waiting to begin treatment. This is a patient&#xD;
      group expected to grow in the future.&#xD;
&#xD;
      This is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e.&#xD;
      prehabilitation, n=233), randomised controlled trial (RCT).&#xD;
&#xD;
      The prehabilitation program is composed of 4 elements: exercise training, nutritional&#xD;
      intervention, correction of anaemia and smoking cessation.&#xD;
&#xD;
      This multicentric, randomised controlled trial is to the investigators knowledge the first&#xD;
      implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge&#xD;
      from different specialties to lower complications and to increase cost effectiveness after&#xD;
      major surgery in elderly, morbid patients.&#xD;
&#xD;
      The primary outcome is measured by the comprehensive complication index (CCI). Secondary&#xD;
      outcomes are physical parameters measured by cardio-pulmonary exercise testing (CPET), grip&#xD;
      strengh, Nutritional Risk Score (NRS). Further outcomes are amongst others smoking behavior,&#xD;
      haemoglobin concentration, days at home at 30 days (DAH30) and quality of recovery 15&#xD;
      (QoR15).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2022</start_date>
  <completion_date type="Anticipated">August 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 30, 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>Randomized, parallel group, multi-centre, multidisciplinary, active controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comprehensive Complication Index (CCI)</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular &amp; Pulmonary</measure>
    <time_frame>Before and after 2-4 weeks of prehabilitation, at 30 days</time_frame>
    <description>Cardio-Pulmonary Exercise Test (CPET): Peak VO2, VO2 at VT1, peak VE, VE/VCO2 slope, O pulse, FEV1, FEV1/FVC, resting HR, HR reserve, resting systolic and diastolic BP, CPAx ICUD and CPAX HosD in case of ICU admission, Maximum inspiratory pressure , Grip strength, NTproBNP, serial hsTroponin in case of raised NTproBNP, change in preoperative P-POSSUM score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition &amp; Bioimpendance</measure>
    <time_frame>At the beginning of study, before and after surgery, at 30 days.</time_frame>
    <description>Nutritional Risk Score (NRS), Bio impedance: weight, muscle mass, fat mass, percent body fat, extracellular water/intracellular water, and phase angle, Fat Free Body Mass (FFM) and Lean body Mass (LBM), Days nil per mouth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anaemia</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Presence of anaemia, Transfusion rates in the first 30 days after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking</measure>
    <time_frame>At the beginning of study, before and after surgery, at 30 days.</time_frame>
    <description>Successful smoking cessation rate, Exhaled CO measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaires for recovery, anxiety and cardiac risk</measure>
    <time_frame>At the beginning of study, before and after surgery, at 30 days.</time_frame>
    <description>Quality of Recovery Score (QoR-15), State-Trait Anxiety Inventory Test (STAI-T), Duke Activity Status Index (DASI)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Other outcomes of interest</measure>
    <time_frame>At 30/90 days</time_frame>
    <description>Length of hospital stay, Days at home at 30 days, Predicted costs for visceral interventions, CCI at 90 days</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">466</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Major Surgery</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients that meet the inclusion criteria will be randomised and scheduled for surgery at least 2 weeks after the diagnosis/decision to proceed to surgery. This timeframe allows the implementation of a minimal 2 weeks (up to 4 weeks) multidisciplinary prehabilitation program. Prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. An individual treatment strategy will be proposed to the patient by a multidisciplinary team consisting of surgeon, anesthesiologist, dietitian and physiotherapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Perioperative care of the control group will be based on standardized, multi-element, ERAS recommendations as already implemented in the different participating clinics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multimodal Prehabilitation</intervention_name>
    <description>A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  comorbid (≥ASA 3)&#xD;
&#xD;
          -  pre-existing fitness deficit: AT&lt;11ml/kg/min respectively VO2peak&lt;14ml/kg/min if AT&#xD;
             unavailable or VE/VCO2 slope &gt; 33&#xD;
&#xD;
          -  scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular&#xD;
             surgery&#xD;
&#xD;
          -  screening at least 2 weeks prior to surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Paralysis or patients with mobility problems (who are unable to exercise),&#xD;
&#xD;
          -  Premorbid conditions or orthopaedic impairments that contraindicate exercise,&#xD;
&#xD;
          -  Cognitive disabilities,&#xD;
&#xD;
          -  Chronic renal failure (need for dialysis)&#xD;
&#xD;
          -  Emergency procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique A Engel, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology and Pain Therapy, University Hospital Bern</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique A Engel, Dr</last_name>
    <phone>0041316322111</phone>
    <email>dominique.engel@insel.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patrick Wuethrich, Prof</last_name>
    <phone>0041316322111</phone>
    <email>patrick.wuethrich@insel.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern</name>
      <address>
        <city>Berne</city>
        <state>BE</state>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique A Engel, Dr</last_name>
      <phone>00316322111</phone>
      <email>dominique.engel@insel.ch</email>
    </contact>
    <contact_backup>
      <last_name>Patrick Wuethrich, Prof</last_name>
      <phone>00416322111</phone>
      <email>patrick.wuethrich@insel.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Insel Gruppe AG, University Hospital Bern</investigator_affiliation>
    <investigator_full_name>Dominique Engel</investigator_full_name>
    <investigator_title>Dr.med.</investigator_title>
  </responsible_party>
  <keyword>Comprehensive Complication Index</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04461301
org study id: PREHAB2020
nct id: NCT04461301
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This multicentric, randomised controlled trial is to the investigators knowledge the first
      implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge
      from different specialties to lower complications and to increase cost effectiveness after
      major surgery in elderly, frail patients.
Postoperative complications occur in up to 50% of patients and major surgery is associated
      with a 20 to 40% reduction in physiological and functional capacity. The elderly have surgery
      4 times more often than the rest of the population, thus in the future a major proportion of
      patients presenting for surgery will be older than 65 years. Elderly patients have more
      postoperative complications, a longer convalescence and higher surgical morbidity and
      mortality. The number and severity of complications are closely related to preoperative
      functional capacity, nutritional state, psychological state, and smoking behavior. Another
      population most probably to benefit from such a program are cancer patients with decreased
      functional health after cancer treatment. Cancer prehabilitation affords an opportunity for
      the patient to improve functional status while waiting to begin treatment. This is a patient
      group expected to grow in the future.

      This is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e.
      prehabilitation, n=233), randomised controlled trial (RCT).

      The prehabilitation program is composed of 4 elements: exercise training, nutritional
      intervention, correction of anaemia and smoking cessation.

      This multicentric, randomised controlled trial is to the investigators knowledge the first
      implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge
      from different specialties to lower complications and to increase cost effectiveness after
      major surgery in elderly, morbid patients.

      The primary outcome is measured by the comprehensive complication index (CCI). Secondary
      outcomes are physical parameters measured by cardio-pulmonary exercise testing (CPET), grip
      strengh, Nutritional Risk Score (NRS). Further outcomes are amongst others smoking behavior,
      haemoglobin concentration, days at home at 30 days (DAH30) and quality of recovery 15
      (QoR15).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, parallel group, multi-centre, multidisciplinary, active controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Comprehensive Complication Index (CCI)
time frame: 30 days after surgery
description: The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally.
measure: Cardiovascular & Pulmonary
time frame: Before and after 2-4 weeks of prehabilitation, at 30 days
description: Cardio-Pulmonary Exercise Test (CPET): Peak VO2, VO2 at VT1, peak VE, VE/VCO2 slope, O pulse, FEV1, FEV1/FVC, resting HR, HR reserve, resting systolic and diastolic BP, CPAx ICUD and CPAX HosD in case of ICU admission, Maximum inspiratory pressure , Grip strength, NTproBNP, serial hsTroponin in case of raised NTproBNP, change in preoperative P-POSSUM score
measure: Nutrition & Bioimpendance
time frame: At the beginning of study, before and after surgery, at 30 days.
description: Nutritional Risk Score (NRS), Bio impedance: weight, muscle mass, fat mass, percent body fat, extracellular water/intracellular water, and phase angle, Fat Free Body Mass (FFM) and Lean body Mass (LBM), Days nil per mouth
measure: Anaemia
time frame: 30 days after surgery
description: Presence of anaemia, Transfusion rates in the first 30 days after surgery.
measure: Smoking
time frame: At the beginning of study, before and after surgery, at 30 days.
description: Successful smoking cessation rate, Exhaled CO measured.
measure: Questionnaires for recovery, anxiety and cardiac risk
time frame: At the beginning of study, before and after surgery, at 30 days.
description: Quality of Recovery Score (QoR-15), State-Trait Anxiety Inventory Test (STAI-T), Duke Activity Status Index (DASI)
measure: Other outcomes of interest
time frame: At 30/90 days
description: Length of hospital stay, Days at home at 30 days, Predicted costs for visceral interventions, CCI at 90 days
arm group label: Intervention
arm group type: Experimental
description: Patients that meet the inclusion criteria will be randomised and scheduled for surgery at least 2 weeks after the diagnosis/decision to proceed to surgery. This timeframe allows the implementation of a minimal 2 weeks (up to 4 weeks) multidisciplinary prehabilitation program. Prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. An individual treatment strategy will be proposed to the patient by a multidisciplinary team consisting of surgeon, anesthesiologist, dietitian and physiotherapist.
arm group label: Control
arm group type: No Intervention
description: Perioperative care of the control group will be based on standardized, multi-element, ERAS recommendations as already implemented in the different participating clinics.
intervention type: Procedure
intervention name: Multimodal Prehabilitation
description: A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique A Engel, Dr
role: Principal Investigator
affiliation: Department of Anaesthesiology and Pain Therapy, University Hospital Bern
last name: Dominique A Engel, Dr
phone: 0041316322111
email: dominique.engel@insel.ch
last name: Patrick Wuethrich, Prof
phone: 0041316322111
email: patrick.wuethrich@insel.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Insel Gruppe AG, University Hospital Bern
investigator full name: Dominique Engel
investigator title: Dr.med.
sharing ipd: No