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/NCT05980325</url>
    </required_header>
    <id_info>
      <org_study_id>TCM-EFFORTv3</org_study_id>
      <nct_id>NCT05980325</nct_id>
    </id_info>
    <brief_title>Exercise For Fighting Oncology Repercussions After Treatment</brief_title>
    <acronym>EFFORT</acronym>
    <official_title>Exercise For Fighting Oncology Repercussions After Treatment: the EFFORT Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitat Pompeu Fabra</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Col·legi de Fisioterapeutes de Catalunya</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ajuntament de Mataró</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universitat Pompeu Fabra</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>
        Cancer survival rates are currently on the verge of 70% at 5 years since diagnosis. Recent&#xD;
        improvements in main cancer therapies including chemotherapy, radiotherapy, surgery and&#xD;
        immunotherapy as well as developments of new biological therapies have significantly improved&#xD;
        survival rates but unfortunately, cancer-related side effects continue to affect many&#xD;
        patients even years after completion of main treatments. Exercise has been shown to not only&#xD;
        ameliorate cancer-related effects before, during and after treatment but also improve&#xD;
        disease-free and overall survival rates by decreasing risk factors associated with cancer&#xD;
        risk and improving resilience to treatment. In this non-randomised, three-arm study, we aim&#xD;
        to assess the effects of three forms of exercise (i.e: Nordic Walking, Aquatic Exercise and&#xD;
        Functional Exercise) on physical performance, cancer-related fatigue, health-related quality&#xD;
        of life and cancer-specific symptoms in a wide range of cancer survivors.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Health-Related Quality of Life</measure>
      <time_frame>12 weeks from baseline</time_frame>
      <description>HRQoL measured with the EORTC Quality of Life C30 questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cancer-related fatigue</measure>
      <time_frame>12 weeks from baseline</time_frame>
      <description>Cancer-related fatigue as measure with the Brief Fatigue Inventory</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiorespiratory fitness</measure>
      <time_frame>12 weeks from baseline</time_frame>
      <description>A steady state cardiopulmonary exercise testing with breath-by-breath analysis and lactate measurement to determine submaximal cardiorespiratory fitness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimated one-repetition maximum</measure>
      <time_frame>12 weeks from baseline</time_frame>
      <description>Estimated maximal muscle strength using a linear Encoder for two main muscle groups: i) chest and ii) quads</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower limb muscle endurance</measure>
      <time_frame>12 weeks from baseline</time_frame>
      <description>Lower limb muscle endurance measured as the maximum number of sit-to-stand repetitions performed in 30 seconds</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional capacity</measure>
      <time_frame>12 weeks from baseline</time_frame>
      <description>Walking distance covered during a self-pace 6 minute walk test</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Neoplasms</condition>
    <arm_group>
      <arm_group_label>Nordic Walking</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this arm will be assigned to a 12-week exercise intervention twice weekly based on Nordic Walking (NW). The intervention will be structured as follows: i) 10 min warm-up, ii) 40 min NW with muscle strengthening exercises interspersed in between and iii) 10 min cool-down. Intensity will be monitored with a heart rate monitor (when available) and/or Borg Scale to reach a moderate intensity for the first 6 weeks (4 - 6 or 55-65% HR reserve) to a moderate-to-high intensity the following weeks (7 - 8 or 65-75% HR reserve).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Aquatic Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will be assigned to a 12-week, twice weekly water-based exercise programme to be conducted at a chest-high swimming pool kept around 30 to 32 degrees Celsius. Each session will be structured as previous: i) 10 min warm up; ii) 40 min of combined endurance and strength exercise training and iii) 10 min cool down. Intensity will be monitored using the Borg Scale to be moderate during the first 6 weeks (4 - 6) and moderate-to-high the following 6 weeks (7-8).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Functional Exercise Training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group, patients will participate in a traditional, circuit-based exercise training at a fitness facility twice daily during 12 weeks. Each session will consist of: i) 10 min warm up; ii) 40 min of combined resistance and endurance training using a circuit-based structure and iii) 10 min cool-down. Intensity will be monitored with a HR monitor (when available) and/or Borg Scale to reach a moderate intensity for the first 6 weeks (4 - 6 or 55-65% HR reserve) and will progress to moderate-to-high over the following weeks (7-8 or 65-75% HR reserve).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Nordic Walking</intervention_name>
      <description>A 12-week Nordic Walking exercise programme supervised twice weekly</description>
      <arm_group_label>Nordic Walking</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Aquatic Exercise</intervention_name>
      <description>A 12-week water-based exercise training programme supervised twice weekly</description>
      <arm_group_label>Aquatic Exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Functional Exercise Training</intervention_name>
      <description>A 12-week circuit-based exercise training programme supervised twice weekly</description>
      <arm_group_label>Functional Exercise Training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults diagnosed with cancer&#xD;
  &#xD;
            -  Completion of any cancer therapy in the previous 3 months with the exception of&#xD;
               hormonal therapy&#xD;
  &#xD;
            -  Patients living within the Maresme Area&#xD;
  &#xD;
            -  No contraindications for exercise (oncology clearance or Physical Activity Readiness&#xD;
               Questionnaire negative)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with any neurologic, cognitive or musculoskeletal impairments that prevent&#xD;
               them to engage in any assessment test or exercise modality.&#xD;
  &#xD;
            -  Patients with unstable cardiac, respiratory or metabolic diseases&#xD;
  &#xD;
            -  Unable to speak or read Catalan or Spanish&#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_contact>
      <last_name>Esther Mur Gimeno, PhD</last_name>
      <phone>+34931696573</phone>
      <email>emur@tecnocampus.cat</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Raquel Sebio García, PhD</last_name>
      <phone>+34634787194</phone>
      <email>rsebio@tecnocampus.cat</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitat Pompeu Fabra</investigator_affiliation>
      <investigator_full_name>Raquel Sebio</investigator_full_name>
      <investigator_title>Senior Lecturer</investigator_title>
    </responsible_party>
    <keyword>Neoplasms</keyword>
    <keyword>Exercise Therapy</keyword>
    <keyword>Side Effects</keyword>
    <keyword>Cancer-related Fatigue</keyword>
    <keyword>Quality of Life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05980325
  org study id: TCM-EFFORTv3
  nct id: NCT05980325
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cancer survival rates are currently on the verge of 70% at 5 years since diagnosis. Recent
        improvements in main cancer therapies including chemotherapy, radiotherapy, surgery and
        immunotherapy as well as developments of new biological therapies have significantly improved
        survival rates but unfortunately, cancer-related side effects continue to affect many
        patients even years after completion of main treatments. Exercise has been shown to not only
        ameliorate cancer-related effects before, during and after treatment but also improve
        disease-free and overall survival rates by decreasing risk factors associated with cancer
        risk and improving resilience to treatment. In this non-randomised, three-arm study, we aim
        to assess the effects of three forms of exercise (i.e: Nordic Walking, Aquatic Exercise and
        Functional Exercise) on physical performance, cancer-related fatigue, health-related quality
        of life and cancer-specific symptoms in a wide range of cancer survivors.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Health-Related Quality of Life
  time frame: 12 weeks from baseline
  description: HRQoL measured with the EORTC Quality of Life C30 questionnaire
  measure: Cancer-related fatigue
  time frame: 12 weeks from baseline
  description: Cancer-related fatigue as measure with the Brief Fatigue Inventory
  measure: Cardiorespiratory fitness
  time frame: 12 weeks from baseline
  description: A steady state cardiopulmonary exercise testing with breath-by-breath analysis and lactate measurement to determine submaximal cardiorespiratory fitness
  measure: Estimated one-repetition maximum
  time frame: 12 weeks from baseline
  description: Estimated maximal muscle strength using a linear Encoder for two main muscle groups: i) chest and ii) quads
  measure: Lower limb muscle endurance
  time frame: 12 weeks from baseline
  description: Lower limb muscle endurance measured as the maximum number of sit-to-stand repetitions performed in 30 seconds
  measure: Functional capacity
  time frame: 12 weeks from baseline
  description: Walking distance covered during a self-pace 6 minute walk test
  arm group label: Nordic Walking
  arm group type: Experimental
  description: Patients in this arm will be assigned to a 12-week exercise intervention twice weekly based on Nordic Walking (NW). The intervention will be structured as follows: i) 10 min warm-up, ii) 40 min NW with muscle strengthening exercises interspersed in between and iii) 10 min cool-down. Intensity will be monitored with a heart rate monitor (when available) and/or Borg Scale to reach a moderate intensity for the first 6 weeks (4 - 6 or 55-65% HR reserve) to a moderate-to-high intensity the following weeks (7 - 8 or 65-75% HR reserve).
  arm group label: Aquatic Exercise
  arm group type: Experimental
  description: Patients in this group will be assigned to a 12-week, twice weekly water-based exercise programme to be conducted at a chest-high swimming pool kept around 30 to 32 degrees Celsius. Each session will be structured as previous: i) 10 min warm up; ii) 40 min of combined endurance and strength exercise training and iii) 10 min cool down. Intensity will be monitored using the Borg Scale to be moderate during the first 6 weeks (4 - 6) and moderate-to-high the following 6 weeks (7-8).
  arm group label: Functional Exercise Training
  arm group type: Active Comparator
  description: In this group, patients will participate in a traditional, circuit-based exercise training at a fitness facility twice daily during 12 weeks. Each session will consist of: i) 10 min warm up; ii) 40 min of combined resistance and endurance training using a circuit-based structure and iii) 10 min cool-down. Intensity will be monitored with a HR monitor (when available) and/or Borg Scale to reach a moderate intensity for the first 6 weeks (4 - 6 or 55-65% HR reserve) and will progress to moderate-to-high over the following weeks (7-8 or 65-75% HR reserve).
  intervention type: Behavioral
  intervention name: Nordic Walking
  description: A 12-week Nordic Walking exercise programme supervised twice weekly
  arm group label: Nordic Walking
  intervention type: Behavioral
  intervention name: Aquatic Exercise
  description: A 12-week water-based exercise training programme supervised twice weekly
  arm group label: Aquatic Exercise
  intervention type: Behavioral
  intervention name: Functional Exercise Training
  description: A 12-week circuit-based exercise training programme supervised twice weekly
  arm group label: Functional Exercise Training
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Esther Mur Gimeno, PhD
  phone: +34931696573
  email: emur@tecnocampus.cat
  last name: Raquel Sebio García, PhD
  phone: +34634787194
  email: rsebio@tecnocampus.cat
  responsible party type: Principal Investigator
  investigator affiliation: Universitat Pompeu Fabra
  investigator full name: Raquel Sebio
  investigator title: Senior Lecturer
  mesh term: Neoplasms
  sharing ipd: No