<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/NCT03029182</url>
  </required_header>
  <id_info>
    <org_study_id>F160215001</org_study_id>
    <nct_id>NCT03029182</nct_id>
  </id_info>
  <brief_title>Simulated-altitude to Optimize Aerobic Exercise Among Breast Cancer Survivors With Limited Mobility</brief_title>
  <official_title>Simulated-Altitude as an Adjunct to Optimize Aerobic Exercise in Obese Breast Cancer Survivors With Limited Ambulatory Function: Pilot Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the utility of hypoxic exercise training to improve cardiovascular&#xD;
      and metabolic health among obese breast cancer survivors. While participants exercise, a&#xD;
      lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach&#xD;
      removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which&#xD;
      is believed to support exercise tolerance. Participants are randomized to either the&#xD;
      treatment (walking+simulated-altitude) or control (walking under normoxic conditions).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer survivors have a two-fold greater risk of having one or more functional limitations&#xD;
      compared to those without a history of cancer. Though exercise interventions in breast cancer&#xD;
      survivors exist, a large portion of women (61%) exhibit some form of lower-body dysfunction&#xD;
      that severely restricts participation in physical activity and exercise. Both physical and&#xD;
      emotional well-being are negatively affected by the combination of increased adiposity,&#xD;
      orthopedic problems and muscle weakness, thus reinforcing a cycle of physical inactivity.&#xD;
&#xD;
      For these reasons, obese breast cancer survivors with walking limitations are faced with a&#xD;
      barrier that greatly increases the difficulty of meeting prescribed exercise guidelines (≥150&#xD;
      weekly minutes of moderate-to-vigorous intensity exercise). Though previous investigations&#xD;
      have demonstrated the safety and benefits of exercise+simulated altitude to improve body fat,&#xD;
      physical endurance and insulin sensitivity, results have been limited to non-cancer&#xD;
      participants only. Given the comorbidities common to breast cancer survivors, specifically,&#xD;
      heart disease risk, lower body joint problems, low aerobic capacity, and fatigue, further&#xD;
      research is needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on retention.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>number of participants completing the 8 week session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on adherence to exercise compliance.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>mean compliance among all participantswith exercise prescription</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on number of adverse events.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Number of adverse events in each group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by a 6 minute walk.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>6 minute walk test, a valid and reliable tool in cancer survivors will be used to evaluate cardiovascular health and mobility. Total distance (in meters) covered over the duration of 6 minutes will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by the cardiorespiratory fitness.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Cardiorespiratory fitness, will be measured by indirect calorimetry during a graded walking test on a treadmill to estimate peak aerobic capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by arterial elasticity.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Arterial elasticity, will be measured by local pulse contour analyses (HDI/Pulse Wave), A non-invasive procedure based on a modified Windkessel model which permits the evaluation of vascular health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by resting heart rate variability.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Heart rate variability, will be determined by R-to-R interval variations in heart rate, used to index sympatho-vagal balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by the fasting glucose.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Typically, a &quot;normal&quot; blood sugar level is identified by experts as anything less than 100 mg/dL after a period of fasting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by C-reactive protein (mg/L) serum assays.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by tumor-necrosis factor-alpha (pg/mL) assays.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-6 (pg/mL) serum assays.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-10 (pg/mL) serum assays.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by body composition (% body fat).</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Body composition, will be measured by dual-energy X-ray absorptiometry during which participants will be scanned while lying supine in light clothing with their arms at their sides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect sizes for walking+simulated-altitude and walking (control) as measured by free-living physical activity.</measure>
    <time_frame>baseline to 8 weeks</time_frame>
    <description>Free-living physical activity, will be measured by a triaxial accelerometer (e.g., Actigraph GT3X). Participants will wear the accelerometer on the hip of their non-dominant side during waking periods and around the wrist when sleeping according to a previously published protocol.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Obesity</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Walking+simulated-altitude</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week exercise training program that involves 3 supervised, treadmill walking sessions each week with 16% oxygen, which will be administered through an exercise mask.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>8-week exercise training program that involves 3 supervised, treadmill walking session each week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Walking+simulated-altitude</intervention_name>
    <description>Participants will walk on a treadmill for up to 50 minutes at a 16% oxygen level (administered via exercise mask), which is similar in altitude to Flagstaff, AZ. The progression of exercise training will be based on a varying percents of heart rate reserve.</description>
    <arm_group_label>Walking+simulated-altitude</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking (control)</intervention_name>
    <description>Participants will walk on a treadmill for up to 50 minutes.The progression of exercise training will be based on a varying percents of heart rate reserve.</description>
    <arm_group_label>Walking (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Physician's medical clearance for participation&#xD;
&#xD;
          2. English-speaking women&#xD;
&#xD;
          3. 18-70 years of age with a history of Stage 0-III breast cancer&#xD;
&#xD;
          4. Preferred walking speed of less than 2.9 mph as measured by a timed 10 meter walk test&#xD;
             (to be performed on-site after consent during preliminary screening) &quot;OR&quot; the&#xD;
             inability to complete a 6-minute walk without stopping (to be performed on-site after&#xD;
             consent during preliminary screening)&#xD;
&#xD;
          5. Body mass index between 30-45 kg/m2&#xD;
&#xD;
          6. ≥1 year post-treatment and not currently receiving or planning to receive&#xD;
             chemo/radiation therapies&#xD;
&#xD;
          7. Not participating in a structured exercise routine&#xD;
&#xD;
          8. In the previous 6 months, not engaging in (on average) ≥60 minutes of moderate or ≥30&#xD;
             minutes of vigorous physical activity per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Males&#xD;
&#xD;
          2. Dementia&#xD;
&#xD;
          3. Medical, psychological, and/or social characteristics that may interfere with the&#xD;
             ability to fully participate in the proposed study activities/assessments (e.g.,&#xD;
             psychosis, schizophrenia)&#xD;
&#xD;
          4. Contraindication to participate in regular exercise training&#xD;
&#xD;
          5. Unwilling to complete prescribed exercise&#xD;
&#xD;
          6. Inability to walk&#xD;
&#xD;
          7. Pregnant&#xD;
&#xD;
          8. Resting oxygen saturation via pulse oximetry below 90%&#xD;
&#xD;
          9. Using home oxygen therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Laura Q. Rogers, MD, MPH</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Cancer</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03029182
org study id: F160215001
nct id: NCT03029182
lead sponsor: 
has dmc: No
The study will evaluate the utility of hypoxic exercise training to improve cardiovascular
      and metabolic health among obese breast cancer survivors. While participants exercise, a
      lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach
      removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which
      is believed to support exercise tolerance. Participants are randomized to either the
      treatment (walking+simulated-altitude) or control (walking under normoxic conditions).
Cancer survivors have a two-fold greater risk of having one or more functional limitations
      compared to those without a history of cancer. Though exercise interventions in breast cancer
      survivors exist, a large portion of women (61%) exhibit some form of lower-body dysfunction
      that severely restricts participation in physical activity and exercise. Both physical and
      emotional well-being are negatively affected by the combination of increased adiposity,
      orthopedic problems and muscle weakness, thus reinforcing a cycle of physical inactivity.

      For these reasons, obese breast cancer survivors with walking limitations are faced with a
      barrier that greatly increases the difficulty of meeting prescribed exercise guidelines (≥150
      weekly minutes of moderate-to-vigorous intensity exercise). Though previous investigations
      have demonstrated the safety and benefits of exercise+simulated altitude to improve body fat,
      physical endurance and insulin sensitivity, results have been limited to non-cancer
      participants only. Given the comorbidities common to breast cancer survivors, specifically,
      heart disease risk, lower body joint problems, low aerobic capacity, and fatigue, further
      research is needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on retention.
time frame: baseline to 8 weeks
description: number of participants completing the 8 week session
measure: Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on adherence to exercise compliance.
time frame: baseline to 8 weeks
description: mean compliance among all participantswith exercise prescription
measure: Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on number of adverse events.
time frame: baseline to 8 weeks
description: Number of adverse events in each group
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by a 6 minute walk.
time frame: baseline to 8 weeks
description: 6 minute walk test, a valid and reliable tool in cancer survivors will be used to evaluate cardiovascular health and mobility. Total distance (in meters) covered over the duration of 6 minutes will be recorded.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by the cardiorespiratory fitness.
time frame: baseline to 8 weeks
description: Cardiorespiratory fitness, will be measured by indirect calorimetry during a graded walking test on a treadmill to estimate peak aerobic capacity.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by arterial elasticity.
time frame: baseline to 8 weeks
description: Arterial elasticity, will be measured by local pulse contour analyses (HDI/Pulse Wave), A non-invasive procedure based on a modified Windkessel model which permits the evaluation of vascular health.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by resting heart rate variability.
time frame: baseline to 8 weeks
description: Heart rate variability, will be determined by R-to-R interval variations in heart rate, used to index sympatho-vagal balance.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by the fasting glucose.
time frame: baseline to 8 weeks
description: Typically, a "normal" blood sugar level is identified by experts as anything less than 100 mg/dL after a period of fasting.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by C-reactive protein (mg/L) serum assays.
time frame: baseline to 8 weeks
description: Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by tumor-necrosis factor-alpha (pg/mL) assays.
time frame: baseline to 8 weeks
description: Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-6 (pg/mL) serum assays.
time frame: baseline to 8 weeks
description: Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-10 (pg/mL) serum assays.
time frame: baseline to 8 weeks
description: Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by body composition (% body fat).
time frame: baseline to 8 weeks
description: Body composition, will be measured by dual-energy X-ray absorptiometry during which participants will be scanned while lying supine in light clothing with their arms at their sides.
measure: The effect sizes for walking+simulated-altitude and walking (control) as measured by free-living physical activity.
time frame: baseline to 8 weeks
description: Free-living physical activity, will be measured by a triaxial accelerometer (e.g., Actigraph GT3X). Participants will wear the accelerometer on the hip of their non-dominant side during waking periods and around the wrist when sleeping according to a previously published protocol.
arm group label: Walking+simulated-altitude
arm group type: Experimental
description: 8-week exercise training program that involves 3 supervised, treadmill walking sessions each week with 16% oxygen, which will be administered through an exercise mask.
arm group label: Walking (control)
arm group type: Active Comparator
description: 8-week exercise training program that involves 3 supervised, treadmill walking session each week.
intervention type: Other
intervention name: Walking+simulated-altitude
description: Participants will walk on a treadmill for up to 50 minutes at a 16% oxygen level (administered via exercise mask), which is similar in altitude to Flagstaff, AZ. The progression of exercise training will be based on a varying percents of heart rate reserve.
arm group label: Walking+simulated-altitude
intervention type: Behavioral
intervention name: Walking (control)
description: Participants will walk on a treadmill for up to 50 minutes.The progression of exercise training will be based on a varying percents of heart rate reserve.
arm group label: Walking (control)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Laura Q. Rogers, MD, MPH
investigator title: Principal Investigator
mesh term: Breast Neoplasms