<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/NCT01715064</url>
  </required_header>
  <id_info>
    <org_study_id>PCA_CSP2012</org_study_id>
    <nct_id>NCT01715064</nct_id>
  </id_info>
  <brief_title>Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients</brief_title>
  <official_title>Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guelph-Humber</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Guelph-Humber</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third&#xD;
      leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with&#xD;
      feelings of anxiety and depression associated with the disease and associated treatments.&#xD;
      Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this&#xD;
      population, but the impact of single bouts of exercise and related psychological or&#xD;
      neurological changes have never been studied. The primary objective of the proposed study is&#xD;
      to examine the effect of an acute bout of exercise on neurophysiological and psychological&#xD;
      indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa.&#xD;
      Participants will be randomly assigned to the intervention (60 min exercise) or control (60&#xD;
      min of television) and will undergo a brief neurological test (cortical silent period) and&#xD;
      psychological questionnaires before and after their group assignment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</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 From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.</measure>
    <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
    <description>CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Profile of Mood States Questionnaire(PoMS)</measure>
    <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
    <description>Correlations will be assessed between cortical silent period and acute mood state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory - Questionnaire(STAI)</measure>
    <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
    <description>Correlations will be assessed between cortical silent period and acute anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale - Questionnaire(HADS)</measure>
    <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
    <description>Correlations will be assessed between cortical silent period and acute anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise-Induced Feelings Inventory - Questionnaire (EIFI)</measure>
    <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
    <description>Correlations will be assessed between cortical silent period and exercise-induced feelings.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>non-exercise control consisting of movie watching.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 hour of moderate intensity exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>1 hour of moderate-intensity exercise</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed PCa;&#xD;
&#xD;
          -  &gt; 6 months post curative therapy for PCa (radical prostatectomy or radiation therapy)&#xD;
             with or without adjuvant androgen deprivation therapy;&#xD;
&#xD;
          -  Willing and able to provide informed consent;&#xD;
&#xD;
          -  If metastatic disease is present, they are asymptomatic; v) n&#xD;
&#xD;
          -  No contraindications to exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe coronary artery disease (Canadian Cardiovascular Society class III or greater);&#xD;
&#xD;
          -  Significant congestive heart failure (New York Heart Association class III or&#xD;
             greater);&#xD;
&#xD;
          -  Uncontrolled pain;&#xD;
&#xD;
          -  Neurological or musculoskeletal co-morbidity inhibiting exercise;&#xD;
&#xD;
          -  Diagnosed psychotic, addictive, or major cognitive disorders or are currently or have&#xD;
             a history of using psychotropic medication (anti-depressants, anti-anxiety,&#xD;
             anti-psychotics, benzodiazepines, etc);&#xD;
&#xD;
          -  Contraindications to magnetic exposure (surgical clips in the brain; cardiac pace&#xD;
             maker or valves; cochlear implants; metal rods, plates, screws in head; shrapnel/metal&#xD;
             fragments in head/eyes; dentures);&#xD;
&#xD;
          -  Prior history of seizures or diagnosis of epilepsy;&#xD;
&#xD;
          -  Left-hand dominant; and&#xD;
&#xD;
          -  No more than two of the following Coronary Risk Factors as defined by the American&#xD;
             College of Sports Medicine[41, 42]:&#xD;
&#xD;
               -  Family history of coronary disease, cigarette smoking, hypertension (Systolic&#xD;
                  Blood Pressure (SBP) &gt; 140 mmHg; Diastolic Blood Pressure (DBP) &gt; 90 mmHg), known&#xD;
                  dyslipidemia, known impaired fasting, glucose (&gt;110 mg/dL), obesity (BMI &gt; 30&#xD;
                  kg/m2 or waist circumference &gt; 102cm), or physically inactive (&lt;150 min of&#xD;
                  moderate intensity physical activity per week)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>May 24, 2013</results_first_submitted>
  <results_first_submitted_qc>January 12, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 10, 2014</results_first_posted>
  <last_update_submitted>January 12, 2014</last_update_submitted>
  <last_update_submitted_qc>January 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Guelph-Humber</investigator_affiliation>
    <investigator_full_name>Daniel Santa Mina</investigator_full_name>
    <investigator_title>Assistant Program Head, Kinesiology</investigator_title>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Exercise</keyword>
  <keyword>Cortical Inhibition</keyword>
  <keyword>Cortical Silent Period</keyword>
  <keyword>Transcranial Magnetic Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible patients were approached for participation by a research coordinator from June to October, 2010. 86 eligible participants were approached for participation and 19 agreed (22% participation rate). Seventeen participants responded to the study poster. The 36 participants were randomly assigned to the exercise (n=18) or control (n=18) group.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Control (1hr of Viewing Emotionally Neutral Movie)</title>
          <description>non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral.</description>
        </group>
        <group group_id="P2">
          <title>Exercise (1hr of Mixed-modality Exercise)</title>
          <description>1 hour of moderate intensity exercise. The session included 5- min warm-up, 25-min of resistance training, 25-min of aerobic training, and 5-min cool-down. Each session was led by a personal trainer and supervised by an exercise physiologist.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>non-exercise control consisting of movie watching.</description>
        </group>
        <group group_id="B2">
          <title>Exercise</title>
          <description>1 hour of moderate intensity exercise.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.6" spread="9.1"/>
                    <measurement group_id="B2" value="67.7" spread="7.6"/>
                    <measurement group_id="B3" value="64.6" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.</title>
        <description>CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.</description>
        <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>non-exercise control consisting of movie watching.</description>
          </group>
          <group group_id="O2">
            <title>Exercise</title>
            <description>1 hour of moderate intensity exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.</title>
          <description>CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.001" spread="0.025"/>
                    <measurement group_id="O2" value="0.006" spread="0.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Profile of Mood States Questionnaire(PoMS)</title>
        <description>Correlations will be assessed between cortical silent period and acute mood state.</description>
        <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>State-Trait Anxiety Inventory - Questionnaire(STAI)</title>
        <description>Correlations will be assessed between cortical silent period and acute anxiety.</description>
        <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Anxiety and Depression Scale - Questionnaire(HADS)</title>
        <description>Correlations will be assessed between cortical silent period and acute anxiety and depression.</description>
        <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exercise-Induced Feelings Inventory - Questionnaire (EIFI)</title>
        <description>Correlations will be assessed between cortical silent period and exercise-induced feelings.</description>
        <time_frame>10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months.</time_frame>
      <desc>Serious adverse and other adverse events were collected during participants' activity in the trial (i.e. the pre-treatment assessment, during the exercise or video sessions, and during the post-treatment assessment).</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>non-exercise control consisting of movie watching.</description>
        </group>
        <group group_id="E2">
          <title>Exercise</title>
          <description>1 hour of moderate intensity exercise.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Daniel Santa Mina</name_or_title>
      <organization>University of Guelph-Humber</organization>
      <phone>416-798-1331 ext 6065</phone>
      <email>daniel.santamina@guelphhumber.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01715064
org study id: PCA_CSP2012
nct id: NCT01715064
lead sponsor: 
has dmc: No
In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third
      leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with
      feelings of anxiety and depression associated with the disease and associated treatments.
      Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this
      population, but the impact of single bouts of exercise and related psychological or
      neurological changes have never been studied. The primary objective of the proposed study is
      to examine the effect of an acute bout of exercise on neurophysiological and psychological
      indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa.
      Participants will be randomly assigned to the intervention (60 min exercise) or control (60
      min of television) and will undergo a brief neurological test (cortical silent period) and
      psychological questionnaires before and after their group assignment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.
time frame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
description: CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.
measure: Profile of Mood States Questionnaire(PoMS)
time frame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
description: Correlations will be assessed between cortical silent period and acute mood state.
measure: State-Trait Anxiety Inventory - Questionnaire(STAI)
time frame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
description: Correlations will be assessed between cortical silent period and acute anxiety.
measure: Hospital Anxiety and Depression Scale - Questionnaire(HADS)
time frame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
description: Correlations will be assessed between cortical silent period and acute anxiety and depression.
measure: Exercise-Induced Feelings Inventory - Questionnaire (EIFI)
time frame: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
description: Correlations will be assessed between cortical silent period and exercise-induced feelings.
arm group label: Control
arm group type: No Intervention
description: non-exercise control consisting of movie watching.
arm group label: Exercise
arm group type: Experimental
description: 1 hour of moderate intensity exercise.
intervention type: Behavioral
intervention name: Exercise
description: 1 hour of moderate-intensity exercise
arm group label: Exercise
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Guelph-Humber
investigator full name: Daniel Santa Mina
investigator title: Assistant Program Head, Kinesiology
mesh term: Prostatic Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 