<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/NCT01709175</url>
  </required_header>
  <id_info>
    <org_study_id>JB-007</org_study_id>
    <nct_id>NCT01709175</nct_id>
  </id_info>
  <brief_title>Strength Training Study for Survivors of Breast and Gynecologic Cancer</brief_title>
  <official_title>The Effect of Resistance Exercise Frequency in Breast and Gynecologic Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare once-a-week vs. twice-a-week strength training in&#xD;
      survivors of breast and gynecologic cancer to determine which is the optimal exercise&#xD;
      prescription.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a result of cancer and its treatment, survivors of breast and gynecologic cancer are&#xD;
      reported to have deficits in both physical and psycho-social health. In cancer survivors&#xD;
      exercise has been shown to improve fitness, increase bone density and lean body mass, enhance&#xD;
      self-esteem, and reduce fatigue. These changes have a positive effect on the survivor's&#xD;
      physical functioning and quality of life. However, there are few studies which have examined&#xD;
      the effects of strength training or studies aimed at determining optimal exercise&#xD;
      prescription in this population. Therefore, the purpose of this study is to compare two&#xD;
      strength training prescriptions (once-a-week vs. twice-a-week strength training) to determine&#xD;
      which prescription (if any) results in greater benefit for survivors. It is hoped that the&#xD;
      results of this study will lead to a better understanding of how strength training improves&#xD;
      the health of survivors and will help inform future exercise guidelines for this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Muscular Strength</measure>
    <time_frame>Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)</time_frame>
    <description>Muscular Strength will be assessed using the predicted one-repetition maximum method (Brzycki method)using the bench press and leg press to measure upper and lower body strength.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Process Measures</measure>
    <time_frame>Final (end of week 13)</time_frame>
    <description>Process measures will provide insight about the feasibility of the exercise prescriptions. Included measures are: recruitment (percent of interested survivors who consent); adherence (the number of sessions attended); compliance (the degree to which the survivors follow the exercise prescription); and safety (all adverse events will be recorded)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Muscular Endurance</measure>
    <time_frame>Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)</time_frame>
    <description>Muscular Endurance will be assessed using the standard load test. Participants will lift a weight equal to 50% one repetition maximum as many times as possible. The bench press and leg press will be used to measure endurance of the upper and lower body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Body Composition</measure>
    <time_frame>Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)</time_frame>
    <description>Body composition will be assessed using bioelectric impedance to determine percent body fat, lean body mass, and fat mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life</measure>
    <time_frame>Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)</time_frame>
    <description>Quality of Life will be assessed using the Medical Outcomes Survey - Short Form. This survey measures multiple aspects of quality of life including: physical function, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, and mental health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Fatigue</measure>
    <time_frame>Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)</time_frame>
    <description>Fatigue will me measured using the Fatigue scale of the Functional Assessment of Cancer Treatment. This is a 13 item questionnaire that measures the degree to which a cancer survivor experiences fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Physical Activity Levels</measure>
    <time_frame>Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)</time_frame>
    <description>Physical activity will be estimated using the Godin Leisure Time Exercise Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Gynecologic Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Uterine Cancer</condition>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Once-a-week Strength Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After completing the introduction to strength training (two sessions in the first week), participants randomized to the once-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet ONCE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Twice-a-week Strength Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After completing the introduction to strength training (two sessions in the first week), participants randomized to the twice-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet TWICE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strength Training</intervention_name>
    <description>This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.</description>
    <arm_group_label>Once-a-week Strength Training</arm_group_label>
    <arm_group_label>Twice-a-week Strength Training</arm_group_label>
    <other_name>Resistance Exercise</other_name>
    <other_name>Weight Training</other_name>
    <other_name>Body Building</other_name>
    <other_name>Exercise</other_name>
    <other_name>Physical Activity</other_name>
    <other_name>Restive Exercise</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female Survivor of Breast or Gynecologic Cancer&#xD;
&#xD;
          -  Completed Primary Treatment (hormone treatments are ok)&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Physician's Permission to Participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High Risk Individuals (determined by questionnaire)&#xD;
&#xD;
          -  Secondary Health Problems that could increase the risk of participating (Includes but&#xD;
             not limited to: Uncontrolled angina/hypertension, heart failure, osteoporosis, brain&#xD;
             metastases, history of seizures).&#xD;
&#xD;
          -  Report participating in a strength training program in the past six (6) months&#xD;
&#xD;
          -  Have had a change in medication in the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Grandy, Ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>CDHA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Exercise Lab: Queen Elizabeth II Dickson Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>June 4, 2015</last_update_submitted>
  <last_update_submitted_qc>June 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Scott Grandy</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Gynecologic Cancer</keyword>
  <keyword>Strength Training</keyword>
  <keyword>Exercise</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Strength</keyword>
  <keyword>Fitness</keyword>
  <keyword>Cancer Survivor</keyword>
  <keyword>Survivor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine 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/NCT01709175
org study id: JB-007
nct id: NCT01709175
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare once-a-week vs. twice-a-week strength training in
      survivors of breast and gynecologic cancer to determine which is the optimal exercise
      prescription.
As a result of cancer and its treatment, survivors of breast and gynecologic cancer are
      reported to have deficits in both physical and psycho-social health. In cancer survivors
      exercise has been shown to improve fitness, increase bone density and lean body mass, enhance
      self-esteem, and reduce fatigue. These changes have a positive effect on the survivor's
      physical functioning and quality of life. However, there are few studies which have examined
      the effects of strength training or studies aimed at determining optimal exercise
      prescription in this population. Therefore, the purpose of this study is to compare two
      strength training prescriptions (once-a-week vs. twice-a-week strength training) to determine
      which prescription (if any) results in greater benefit for survivors. It is hoped that the
      results of this study will lead to a better understanding of how strength training improves
      the health of survivors and will help inform future exercise guidelines for this population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Changes in Muscular Strength
time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
description: Muscular Strength will be assessed using the predicted one-repetition maximum method (Brzycki method)using the bench press and leg press to measure upper and lower body strength.
measure: Process Measures
time frame: Final (end of week 13)
description: Process measures will provide insight about the feasibility of the exercise prescriptions. Included measures are: recruitment (percent of interested survivors who consent); adherence (the number of sessions attended); compliance (the degree to which the survivors follow the exercise prescription); and safety (all adverse events will be recorded)
measure: Changes in Muscular Endurance
time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
description: Muscular Endurance will be assessed using the standard load test. Participants will lift a weight equal to 50% one repetition maximum as many times as possible. The bench press and leg press will be used to measure endurance of the upper and lower body.
measure: Changes in Body Composition
time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
description: Body composition will be assessed using bioelectric impedance to determine percent body fat, lean body mass, and fat mass.
measure: Changes in Quality of Life
time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
description: Quality of Life will be assessed using the Medical Outcomes Survey - Short Form. This survey measures multiple aspects of quality of life including: physical function, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, and mental health.
measure: Changes in Fatigue
time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
description: Fatigue will me measured using the Fatigue scale of the Functional Assessment of Cancer Treatment. This is a 13 item questionnaire that measures the degree to which a cancer survivor experiences fatigue
measure: Changes in Physical Activity Levels
time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
description: Physical activity will be estimated using the Godin Leisure Time Exercise Questionnaire.
arm group label: Once-a-week Strength Training
arm group type: Experimental
description: After completing the introduction to strength training (two sessions in the first week), participants randomized to the once-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet ONCE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises.
arm group label: Twice-a-week Strength Training
arm group type: Experimental
description: After completing the introduction to strength training (two sessions in the first week), participants randomized to the twice-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet TWICE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises.
intervention type: Behavioral
intervention name: Strength Training
description: This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.
arm group label: Once-a-week Strength Training
arm group label: Twice-a-week Strength Training
other name: Resistance Exercise
other name: Weight Training
other name: Body Building
other name: Exercise
other name: Physical Activity
other name: Restive Exercise
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott Grandy, Ph D
role: Principal Investigator
affiliation: CDHA
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Scott Grandy
investigator title: Principle Investigator
mesh term: Uterine Neoplasms