<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/NCT02982564</url>
  </required_header>
  <id_info>
    <org_study_id>1SC3GM116684-01</org_study_id>
    <nct_id>NCT02982564</nct_id>
  </id_info>
  <brief_title>Effect of Low vs Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors</brief_title>
  <official_title>Effect of Low-intensity Versus Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Puerto Rico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Puerto Rico</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>
      The purpose of this study is to evaluate the effect of two exercise programs: 1) one program&#xD;
      will be at low intensity; 2) the other program will be at moderate intensity. One hundred&#xD;
      forty two women who are breast cancer survivors will be recruited. Participants will be&#xD;
      educated on a home exercise program to be performed at either low or moderate intensity,&#xD;
      according to group assignment. Evaluations to participants will consist of function and&#xD;
      quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Improvements in early diagnosis and treatment for breast cancer in women have resulted in&#xD;
      increased survivorship. An unintended consequence of increased survival, however, is that&#xD;
      more women are living with the negative sequelae associated with cancer treatment, including&#xD;
      decreased physical function. Exercise has been beneficial in arresting these sequelae, but&#xD;
      adherence to exercise guidelines continues to be a challenge. As most breast cancer survivors&#xD;
      are middle-aged and older, an alternative to enhance exercise engagement and adherence might&#xD;
      be providing a low intensity exercise program. The overall purpose of this study is to assess&#xD;
      the impact of a low intensity versus moderate intensity endurance exercise program on&#xD;
      physical functioning on breast cancer survivors. It is hypothesized that participants of the&#xD;
      low intensity exercise program will demonstrate similar physical functioning as participants&#xD;
      in the moderate intensity exercise program. The Theory of Planned Behavior will serve as&#xD;
      framework for the intervention. A convenience sample of 142 women, residents of Puerto Rico,&#xD;
      age 50 or older, with a diagnosis of breast cancer, stage 0 thru III, who have received&#xD;
      surgical treatment for breast cancer, with or without adjuvant therapy, will be randomly&#xD;
      assigned to a low intensity or moderate intensity endurance intervention. Both interventions&#xD;
      will be home-based, have a duration of 6 months, and be provided by physical therapists. An&#xD;
      evaluator blinded to group assignment will assess participants at baseline and at completion&#xD;
      of the intervention. Primary outcome measures will consist of physical functioning, and&#xD;
      health-related quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">May 2023</completion_date>
  <primary_completion_date type="Actual">May 2023</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cardiovascular fitness: Six-minute walk test</measure>
    <time_frame>At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.</time_frame>
    <description>Will be used to assess physical function in cancer survivors. It has been validated to assess exercise tolerance (American Thoracic Society, 2002) and has been recommended as a test suitable for fitness, as it is highly correlated with oxygen uptake. An increase in walking distance indicates an improvement in performance. Data will be collected on distance walked (meters), number of rests, and duration of rest during the 6 minutes. Rating of perceived exertion will be monitored. Heart rate and oxygen saturation will be examined using a pulse oximeter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0/1.1 General Health. The Spanish version (Salud general) will be used. It contains two subdomains: Global Physical Health and Global Mental Health. The final score can be converted to a score for the EUROQoL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Functioning</measure>
    <time_frame>At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.</time_frame>
    <description>PROMIS Item Bank v. 1.2 Physical Function. The Spanish version (Capacidad de Funcionamiento Físico - Cuestionario Abreviado 20) will be used. It consists of 20 items, measuring upper extremity function, as well as gross motor function such as walking and stairs use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.</time_frame>
    <description>Inventario -II de depresión de Beck (BDI-II). The Spanish version has proper psychometric properties for assessment of depression (internal consistency, obtaining a Cronbach alfa of 0.89 and has reported known-group validity; Vega-Dienstmaier, 2014).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Image</measure>
    <time_frame>At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.</time_frame>
    <description>Body Appreciation Scale-2 (BAS-2; Tylka &amp; Wood-Barcalow, 2014), Spanish version will be used to measure body appreciation, an aspect that encompasses positive self-evaluation of body image. It has 13 items with responses ranging from 1 (never) to 5 (always). The Spanish BAS showed adequate internal consistency (Cronbach's α = .91) and construct validity (correlations with BMI, influence of the body shape model, perceived stress, coping strategies, self-esteem and variables from the Eating Disorders Inventory-2). Test-retest reliability ranged from .88 to .90.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity</measure>
    <time_frame>At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.</time_frame>
    <description>Accelerometers will be used to evaluate the amount of time spent in low to moderate and moderate to vigorous physical activity. Accelerometry has been found to be a valid measure of physical activity, as compared to oxygen uptake and calorimetry (Hendelman et al., 2000; Kuffel, et al., 2011) and has been used nationally by the National Health and Nutritional Examination Survey (NHANES) study to document, more precisely than self-reported measures, the intensity and time of physical activity (Hawkins et al., 2009). The procedures established by NHANES (CDC, 2005) will be followed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Time spend in Habitual Physical Activities</measure>
    <time_frame>At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.</time_frame>
    <description>International Physical Activity Questionnaire (IPAQ, 2002, self-administered, long Spanish version). The IPAQ assesses multiple domains of activity such as leisure, occupation, household, and transport, among others (Craig et al., 2003). This questionnaire has proved to be reliable (Roman-Viñas et al., 2010), and has been validated with accelerometer, pedometer, physical activity log, and maximal oxygen uptake (van Poppel et al., 2010).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>At 6-month follow up.</time_frame>
    <description>Exercise logs. Participants will be asked to record week number and type and duration of exercise. Logs will be collected at the 6-month evaluation session.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Low Intensity Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants engage in low intensity endurance exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Intensity Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants engage in moderate intensity endurance exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Program Low Intensity</intervention_name>
    <description>This arm includes a low-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.</description>
    <arm_group_label>Low Intensity Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Program Moderate Intensity</intervention_name>
    <description>This arm includes a moderate-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.</description>
    <arm_group_label>Moderate Intensity Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Fifty years of age or older&#xD;
&#xD;
          2. Be a resident of the San Juan metropolitan area of Puerto Rico (PR)&#xD;
&#xD;
          3. Diagnosed with breast cancer&#xD;
&#xD;
          4. Be classified in breast cancer stage grouping 0 to III according to the American Joint&#xD;
             Committee on Cancer Classification of Malignant Tumors (TNM) Staging System (2013)&#xD;
&#xD;
          5. Have completed adjuvant curative therapy at least two months to 5 years prior to&#xD;
             recruitment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who have contraindications to exercise, such as extreme fatigue or anemia,&#xD;
             unstable cardiac disease; uncontrolled diabetes; uncontrolled hypertension;&#xD;
             coagulopathies; inability to ambulate independently&#xD;
&#xD;
          2. Women with metastasis or secondary cancers&#xD;
&#xD;
          3. Women who already meet the national standard for exercise (≥ 150 minutes per week of&#xD;
             moderate exercise).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana L Mulero-Portela, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Puerto Rico Medical Sciences Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Puerto Rico Clinical and Translational Research Consortium</name>
      <address>
        <city>San Juan</city>
        <zip>00936-5067</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Physical Functioning</keyword>
  <keyword>Hispanic</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>Yes</sharing_ipd>
    <ipd_description>Data will be presented at the conclusion of the study.</ipd_description>
  </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/NCT02982564
org study id: 1SC3GM116684-01
nct id: NCT02982564
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of two exercise programs: 1) one program
      will be at low intensity; 2) the other program will be at moderate intensity. One hundred
      forty two women who are breast cancer survivors will be recruited. Participants will be
      educated on a home exercise program to be performed at either low or moderate intensity,
      according to group assignment. Evaluations to participants will consist of function and
      quality of life.
Improvements in early diagnosis and treatment for breast cancer in women have resulted in
      increased survivorship. An unintended consequence of increased survival, however, is that
      more women are living with the negative sequelae associated with cancer treatment, including
      decreased physical function. Exercise has been beneficial in arresting these sequelae, but
      adherence to exercise guidelines continues to be a challenge. As most breast cancer survivors
      are middle-aged and older, an alternative to enhance exercise engagement and adherence might
      be providing a low intensity exercise program. The overall purpose of this study is to assess
      the impact of a low intensity versus moderate intensity endurance exercise program on
      physical functioning on breast cancer survivors. It is hypothesized that participants of the
      low intensity exercise program will demonstrate similar physical functioning as participants
      in the moderate intensity exercise program. The Theory of Planned Behavior will serve as
      framework for the intervention. A convenience sample of 142 women, residents of Puerto Rico,
      age 50 or older, with a diagnosis of breast cancer, stage 0 thru III, who have received
      surgical treatment for breast cancer, with or without adjuvant therapy, will be randomly
      assigned to a low intensity or moderate intensity endurance intervention. Both interventions
      will be home-based, have a duration of 6 months, and be provided by physical therapists. An
      evaluator blinded to group assignment will assess participants at baseline and at completion
      of the intervention. Primary outcome measures will consist of physical functioning, and
      health-related quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change in Cardiovascular fitness: Six-minute walk test
time frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
description: Will be used to assess physical function in cancer survivors. It has been validated to assess exercise tolerance (American Thoracic Society, 2002) and has been recommended as a test suitable for fitness, as it is highly correlated with oxygen uptake. An increase in walking distance indicates an improvement in performance. Data will be collected on distance walked (meters), number of rests, and duration of rest during the 6 minutes. Rating of perceived exertion will be monitored. Heart rate and oxygen saturation will be examined using a pulse oximeter.
measure: Change in Quality of Life
time frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
description: Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0/1.1 General Health. The Spanish version (Salud general) will be used. It contains two subdomains: Global Physical Health and Global Mental Health. The final score can be converted to a score for the EUROQoL.
measure: Change in Functioning
time frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
description: PROMIS Item Bank v. 1.2 Physical Function. The Spanish version (Capacidad de Funcionamiento Físico - Cuestionario Abreviado 20) will be used. It consists of 20 items, measuring upper extremity function, as well as gross motor function such as walking and stairs use.
measure: Change in Depression
time frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
description: Inventario -II de depresión de Beck (BDI-II). The Spanish version has proper psychometric properties for assessment of depression (internal consistency, obtaining a Cronbach alfa of 0.89 and has reported known-group validity; Vega-Dienstmaier, 2014).
measure: Change in Body Image
time frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
description: Body Appreciation Scale-2 (BAS-2; Tylka & Wood-Barcalow, 2014), Spanish version will be used to measure body appreciation, an aspect that encompasses positive self-evaluation of body image. It has 13 items with responses ranging from 1 (never) to 5 (always). The Spanish BAS showed adequate internal consistency (Cronbach's α = .91) and construct validity (correlations with BMI, influence of the body shape model, perceived stress, coping strategies, self-esteem and variables from the Eating Disorders Inventory-2). Test-retest reliability ranged from .88 to .90.
measure: Change in Physical Activity
time frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
description: Accelerometers will be used to evaluate the amount of time spent in low to moderate and moderate to vigorous physical activity. Accelerometry has been found to be a valid measure of physical activity, as compared to oxygen uptake and calorimetry (Hendelman et al., 2000; Kuffel, et al., 2011) and has been used nationally by the National Health and Nutritional Examination Survey (NHANES) study to document, more precisely than self-reported measures, the intensity and time of physical activity (Hawkins et al., 2009). The procedures established by NHANES (CDC, 2005) will be followed.
measure: Change in Time spend in Habitual Physical Activities
time frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
description: International Physical Activity Questionnaire (IPAQ, 2002, self-administered, long Spanish version). The IPAQ assesses multiple domains of activity such as leisure, occupation, household, and transport, among others (Craig et al., 2003). This questionnaire has proved to be reliable (Roman-Viñas et al., 2010), and has been validated with accelerometer, pedometer, physical activity log, and maximal oxygen uptake (van Poppel et al., 2010).
measure: Adherence
time frame: At 6-month follow up.
description: Exercise logs. Participants will be asked to record week number and type and duration of exercise. Logs will be collected at the 6-month evaluation session.
arm group label: Low Intensity Exercise
arm group type: Experimental
description: Participants engage in low intensity endurance exercise.
arm group label: Moderate Intensity Exercise
arm group type: Experimental
description: Participants engage in moderate intensity endurance exercise.
intervention type: Behavioral
intervention name: Exercise Program Low Intensity
description: This arm includes a low-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.
arm group label: Low Intensity Exercise
intervention type: Behavioral
intervention name: Exercise Program Moderate Intensity
description: This arm includes a moderate-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.
arm group label: Moderate Intensity Exercise
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ana L Mulero-Portela, PhD
role: Principal Investigator
affiliation: University of Puerto Rico Medical Sciences Campus
facility: 
country: Puerto Rico
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: Data will be presented at the conclusion of the study.