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/NCT06013527</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-COHS-STD-95-May-2023</org_study_id>
      <nct_id>NCT06013527</nct_id>
    </id_info>
    <brief_title>Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE.</brief_title>
    <official_title>Physical Rehabilitation Program for Cardiorespiratory Health and Quality of Life Among Breast Cancer Survivors in UAE - A Randomized Control Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gulf Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gulf Medical University</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 randomized control trial aims to analyze the changes in cardiovascular endurance and&#xD;
        quality of life domains for breast cancer survivors in the United Arab Emirates using a&#xD;
        long-term 2-month physical rehabilitation program adapted from the BREX protocol.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cancer is a medical condition where some cells of the body reproduce uncontrollably and&#xD;
        metastasize to other parts of the body. The burden of the disease is significantly high both&#xD;
        at the global and national levels. In the year 2020, 19.3 million total new cases of cancer&#xD;
        were recorded, and cancer deaths were estimated to be 10.0 million, for both males and&#xD;
        females. In UAE, cancer was found to be the third leading cause of death. Specifically in&#xD;
        UAE, breast cancer was ranked 1 due to its prevalence, incidence, and mortality. Amongst all&#xD;
        types of cancers, breast carcinoma is very common among females across the globe which&#xD;
        significantly affects their Quality of Life (QoL) with poor cardiovascular tolerance even&#xD;
        after the carcinoma has been treated or removed. Thus, the associated morbidity among breast&#xD;
        cancer survivors affects all domains of quality of life comprising physical health,&#xD;
        psychological health, level of independence, social interactions, and environmental changes.&#xD;
  &#xD;
        It is well known that QoL domains are interrelated where physical rehabilitation is of utmost&#xD;
        importance as it can help to address all domains. In addition, the &quot;cardiorespiratory&#xD;
        systems&quot; are the main functional unit of our circulatory system and provide energy for body&#xD;
        movements. Poor cardiovascular endurance has been very commonly reported among breast cancer&#xD;
        survivors, which has a direct effect on individuals' level of independence and ability to&#xD;
        participate in the social environment thereby adding to overall QoL. Physical rehabilitation&#xD;
        forms an important part of breast cancer management pre- and post-surgical. In the&#xD;
        pre-surgical phase, rehabilitation can help the individual to sustain the ill effect of&#xD;
        post-surgical complications better. However, it is the post-surgical phase that requires more&#xD;
        attention and rehabilitation strategies to combat the situation and help the individual&#xD;
        regain their functional level near normal. The importance and benefits of physical&#xD;
        rehabilitation among breast cancer survivors have been well reported with evidence in the&#xD;
        literature.&#xD;
  &#xD;
        Integrated structured exercise programs have been defined and prescribed to check their&#xD;
        benefits over the QoL domains. In addition, a study reported that while structured exercise&#xD;
        programs should focus on improving cardiorespiratory fitness and muscular strength during&#xD;
        exercise training, these programs should consider physical activity outside of training, if&#xD;
        well-tolerated, to potentially further lower fatigue and improve QOL in cancer survivors.&#xD;
        Thus, an individual-centric approach could be more beneficial. Although a recent study&#xD;
        reported a higher incidence and prevalence of breast cancer in the UAE population, no&#xD;
        published data was found on the application of the recommended exercise regimen,&#xD;
        rehabilitation program, and guidelines for breast cancer survivors in the UAE despite a&#xD;
        significant level of evidence.&#xD;
  &#xD;
        Therefore, the proposed research project aims to improve the QoL domains and Cardiovascular&#xD;
        endurance among breast cancer survivors in the United Arab Emirates using physical&#xD;
        rehabilitation and recommended exercise programs. An individual-centric approach is intended&#xD;
        to maximize the benefits of physical rehabilitation and to match individual needs&#xD;
        efficiently.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cardiorespiratory health</measure>
      <time_frame>0-5 months</time_frame>
      <description>A 2-km walk test (UKK walk test, Tampere, Finland) would be done along to evaluate the submaximal Vo2 analysis additionally peak exercise minute ventilation, and direct maximal voluntary ventilation will be assessed to evaluate pulmonary limitation to exercise. This be measured through Spirometry.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Research</measure>
      <time_frame>0-5 months</time_frame>
      <description>The European Organization for Research and Treatment of Cancer (EORTC) questionnaire (EORTC QLQ-C30).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Physical Therapy Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group will receive a structured exercise program which will run for 2 months and a follow-up will be done after 3 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will continue with their routine life and will receive standard care given by the hospital.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Supervised Training</intervention_name>
      <description>Two different classes over alternate weeks twice per week :&#xD;
  60-minute step aerobics class (Given week 1,3,5,7)&#xD;
  60 minutes circuit training class (Given week 2,4,6,8)&#xD;
  Each class will include warm-up and cool-down periods both lasting 10-15 min. The exercise period of 30 minutes the maximum target RPE would be set at 14-16 on a 20-point BORG scale, a level of exercise that feels &quot;somewhat hard&quot; or &quot;hard&quot; and coincides with about 86-92% of maximal heart rate, 76-85% of maximal VO 2 and 5-7 metabolic equivalents (METs) ideal for improving the related domains of QoL and Cardiovascular endurance (12). During the first 3 weeks, the participants would exercise at a lower level of RPE (approximately 11-13), to adapt to the training and so that newly recruited participants could also join the group without difficulty.</description>
      <arm_group_label>Physical Therapy Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Individually tailored home program</intervention_name>
      <description>The type of home training would mainly consist of endurance training such as walking, Nordic walking, or aerobic training, but it would also include jumps and leaps like step aerobics to promote bone health. The Participants will be asked to perform these thrice per week.</description>
      <arm_group_label>Physical Therapy Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients suffering from breast cancer who have undergone Chemotherapy, Mastectomy, and&#xD;
               cleared for post-surgical physical rehabilitation.&#xD;
  &#xD;
            -  Age group -18 years to 65 years&#xD;
  &#xD;
            -  Female patients only (gender predisposition)&#xD;
  &#xD;
            -  Diagnosed with stage I-stage IIIa breast cancer. (As other stages of cancer include&#xD;
               metastasis).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with prior cardiorespiratory disorders, cognitive dysfunction, and&#xD;
               other health problems that would prevent safe participation.&#xD;
  &#xD;
            -  Active breast cancer patients.&#xD;
  &#xD;
            -  Participants who engaged in physical activity like the intervention group in any form.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Thumbay Medical City, GMU</name>
        <address>
          <city>Al Jurf</city>
          <state>Ajman</state>
          <country>United Arab Emirates</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Arab Emirates</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gulf Medical University</investigator_affiliation>
      <investigator_full_name>Fatima Abdul Rashid</investigator_full_name>
      <investigator_title>Ms.</investigator_title>
    </responsible_party>
    <keyword>Breast cancer survivor</keyword>
    <keyword>Quality of life</keyword>
    <keyword>Cardiorespiratory health</keyword>
    <keyword>Physical rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast 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/NCT06013527
  org study id: IRB-COHS-STD-95-May-2023
  nct id: NCT06013527
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This randomized control trial aims to analyze the changes in cardiovascular endurance and
        quality of life domains for breast cancer survivors in the United Arab Emirates using a
        long-term 2-month physical rehabilitation program adapted from the BREX protocol.
  Cancer is a medical condition where some cells of the body reproduce uncontrollably and
        metastasize to other parts of the body. The burden of the disease is significantly high both
        at the global and national levels. In the year 2020, 19.3 million total new cases of cancer
        were recorded, and cancer deaths were estimated to be 10.0 million, for both males and
        females. In UAE, cancer was found to be the third leading cause of death. Specifically in
        UAE, breast cancer was ranked 1 due to its prevalence, incidence, and mortality. Amongst all
        types of cancers, breast carcinoma is very common among females across the globe which
        significantly affects their Quality of Life (QoL) with poor cardiovascular tolerance even
        after the carcinoma has been treated or removed. Thus, the associated morbidity among breast
        cancer survivors affects all domains of quality of life comprising physical health,
        psychological health, level of independence, social interactions, and environmental changes.
  
        It is well known that QoL domains are interrelated where physical rehabilitation is of utmost
        importance as it can help to address all domains. In addition, the "cardiorespiratory
        systems" are the main functional unit of our circulatory system and provide energy for body
        movements. Poor cardiovascular endurance has been very commonly reported among breast cancer
        survivors, which has a direct effect on individuals' level of independence and ability to
        participate in the social environment thereby adding to overall QoL. Physical rehabilitation
        forms an important part of breast cancer management pre- and post-surgical. In the
        pre-surgical phase, rehabilitation can help the individual to sustain the ill effect of
        post-surgical complications better. However, it is the post-surgical phase that requires more
        attention and rehabilitation strategies to combat the situation and help the individual
        regain their functional level near normal. The importance and benefits of physical
        rehabilitation among breast cancer survivors have been well reported with evidence in the
        literature.
  
        Integrated structured exercise programs have been defined and prescribed to check their
        benefits over the QoL domains. In addition, a study reported that while structured exercise
        programs should focus on improving cardiorespiratory fitness and muscular strength during
        exercise training, these programs should consider physical activity outside of training, if
        well-tolerated, to potentially further lower fatigue and improve QOL in cancer survivors.
        Thus, an individual-centric approach could be more beneficial. Although a recent study
        reported a higher incidence and prevalence of breast cancer in the UAE population, no
        published data was found on the application of the recommended exercise regimen,
        rehabilitation program, and guidelines for breast cancer survivors in the UAE despite a
        significant level of evidence.
  
        Therefore, the proposed research project aims to improve the QoL domains and Cardiovascular
        endurance among breast cancer survivors in the United Arab Emirates using physical
        rehabilitation and recommended exercise programs. An individual-centric approach is intended
        to maximize the benefits of physical rehabilitation and to match individual needs
        efficiently.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: Cardiorespiratory health
  time frame: 0-5 months
  description: A 2-km walk test (UKK walk test, Tampere, Finland) would be done along to evaluate the submaximal Vo2 analysis additionally peak exercise minute ventilation, and direct maximal voluntary ventilation will be assessed to evaluate pulmonary limitation to exercise. This be measured through Spirometry.
  measure: Quality of Research
  time frame: 0-5 months
  description: The European Organization for Research and Treatment of Cancer (EORTC) questionnaire (EORTC QLQ-C30).
  arm group label: Physical Therapy Intervention
  arm group type: Experimental
  description: The intervention group will receive a structured exercise program which will run for 2 months and a follow-up will be done after 3 months.
  arm group label: Control Group
  arm group type: No Intervention
  description: This group will continue with their routine life and will receive standard care given by the hospital.
  intervention type: Other
  intervention name: Supervised Training
  description: Two different classes over alternate weeks twice per week :
  60-minute step aerobics class (Given week 1,3,5,7)
  60 minutes circuit training class (Given week 2,4,6,8)
  Each class will include warm-up and cool-down periods both lasting 10-15 min. The exercise period of 30 minutes the maximum target RPE would be set at 14-16 on a 20-point BORG scale, a level of exercise that feels "somewhat hard" or "hard" and coincides with about 86-92% of maximal heart rate, 76-85% of maximal VO 2 and 5-7 metabolic equivalents (METs) ideal for improving the related domains of QoL and Cardiovascular endurance (12). During the first 3 weeks, the participants would exercise at a lower level of RPE (approximately 11-13), to adapt to the training and so that newly recruited participants could also join the group without difficulty.
  arm group label: Physical Therapy Intervention
  intervention type: Other
  intervention name: Individually tailored home program
  description: The type of home training would mainly consist of endurance training such as walking, Nordic walking, or aerobic training, but it would also include jumps and leaps like step aerobics to promote bone health. The Participants will be asked to perform these thrice per week.
  arm group label: Physical Therapy Intervention
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United Arab Emirates
  responsible party type: Principal Investigator
  investigator affiliation: Gulf Medical University
  investigator full name: Fatima Abdul Rashid
  investigator title: Ms.
  mesh term: Breast Neoplasms
  sharing ipd: No