<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/NCT03776045</url>
  </required_header>
  <id_info>
    <org_study_id>PROSCARDIO1992</org_study_id>
    <nct_id>NCT03776045</nct_id>
  </id_info>
  <brief_title>PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)</brief_title>
  <acronym>PROSCARDIO</acronym>
  <official_title>Effects of Exercise in Prostate Cancer Patients Initiating Androgen Deprivation Therapy: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norfolk and Norwich University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of East Anglia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates whether exercise can reduce treatment-related adverse effects in&#xD;
      prostate cancer patients initiating androgen deprivation therapy. Half of recruited&#xD;
      participants completed a 3-month exercise intervention, while the other half did not perform&#xD;
      any supervised exercise. It was anticipated that exercise would have a positive effect on&#xD;
      body composition, cardiorespiratory fitness and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Androgen deprivation therapy (ADT) is routinely used as first-line treatment for locally&#xD;
      advanced and metastatic prostate cancer. However, it is associated with many side effects&#xD;
      such as increased fat mass and reduced skeletal muscle mass, cardiorespiratory fitness and&#xD;
      metabolic health. Ultimately, these negative changes induced by ADT contribute to reduced&#xD;
      health-related quality of life (HRQoL). This study evaluates whether 3-months of exercise can&#xD;
      mitigate treatment toxicity in prostate cancer patients initiating ADT.&#xD;
&#xD;
      In a parallel groups, prospective, randomised controlled design, participants were randomly&#xD;
      allocated to a standard care control group or standard care plus exercise group. The exercise&#xD;
      group completed 3-months of combined aerobic and resistance training. The standard care group&#xD;
      did not receive any supervised exercise or specific physical activity recommendations.&#xD;
      Outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up)&#xD;
      endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2013</start_date>
  <completion_date type="Actual">February 3, 2016</completion_date>
  <primary_completion_date type="Actual">February 3, 2016</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>
    <intervention_model_description>After baseline measures were collected, participants were randomly allocated (1:1) to standard care or standard care plus exercise using a randomisation sequence created by an independent researcher (nQuery, Statistical Solutions, USA). Treatment allocation was concealed from the research team until after baseline measurements were collected.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessors and data analysts were blind to treatment allocation. It was not possible to blind participants or the intervention facilitator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Whole body fat mass (kg)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month endpoint</time_frame>
    <description>Whole body fat mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This was chosen as the primary outcome because adiposity has shown a high propensity to increase during the initial phases of androgen deprivation therapy, more so than other measures (Galvao et al. 2011), which highlights the importance of targeting body fat at this stage of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole body fat mass (kg)</measure>
    <time_frame>Adjusted mean difference between groups at 6-month endpoint</time_frame>
    <description>Whole body fat mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This was chosen as the primary outcome because adiposity has shown a high propensity to increase during the initial phases of androgen deprivation therapy, more so than other measures (Galvao et al. 2011), which highlights the importance of targeting body fat at this stage of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole body fat-free mass (kg)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Whole body fat-free mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This method is highly valid for measuring changes in body composition (Savastano et al. 2010).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measurements (cm)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Waist, hip, mid-upper arm, forearm, mid-thigh and calf circumferences were measured with a non-stretching tape using standard techniques.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak oxygen consumption (VO2peak, ml/kg/min)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Determined as the highest oxygen consumption (V̇O2) attained during the cardiopulmonary exercise test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory anaerobic threshold (ml/kg/min)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Estimated using the modified V-slope method and confirmed by evaluating ventilatory equivalents and end-tidal pressures. Two analysts independently determined the ventilatory anaerobic threshold, with discrepancies of ≥ 7.5% resolved through discussion and consultation with a third analyst if necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory equivalents for O2 (V̇E/V̇O2) and CO2 (V̇E/V̇CO2)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Ratio of minute ventilation to O2 consumption and CO2 output at the ventilatory anaerobic threshold</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen pulse (ml/beat)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Ratio of oxygen consumption to heart rate at peak exercise during the cardiopulmonary exercise test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen uptake efficiency slope (OUES)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Determined as the linear relationship between oxygen uptake and the logarithmic transformation of minute ventilation during the cardiopulmonary exercise test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of cholesterol (mmol/L)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Concentrations of total cholesterol, low-density lipoprotein (LDL-C) and high-density lipoprotein (HDL-C) were measured from venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of triglycerides (mmol/L)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>The concentration of triglycerides was measured from venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of testosterone (nmol/L)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Concentration of total testosterone was measured from venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of sex hormone binding globulin (nmol/L)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Concentration of sex hormone binding globulin was measured from venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QRISK®2-2017 score</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>The percent risk of a cardiovascular disease event occurring in the next 10 years was calculated with QRISK®2-2017 Web Calculator (https://qrisk.org/2017). The total score ranges from 0 to 100 %, with higher scores indicating a greater risk of cardiovascular disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gleason score</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Gleason scores were measured from prostate biopsies. A score of 1 to 5 is assigned to the cells that make up the largest area of the tumor and another score of 1 to 5 is assigned to the cells that comprise the next largest area. A total Gleason score is then calculated by adding both of these scores together. Total scores ranged from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate specific antigen (ng/mL)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Concentration of prostate specific antigen was measured from venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skinfold thickness (mm)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Skinfold thickness was measured at suprailiac and subscapular sites with a skinfold caliper (Harpenden Skinfold Caliper, Baty International, Sussex, UK).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand grip strength (kg)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Hand grip strength was measured with an analogue dynamometer (Takei Scientific Instruments Ltd., Tokyo, Japan).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (version 4)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Disease-specific health-related quality of life was assessed with the FACT-P 39-item questionnaire (version 4). Each item has a 5-point Likert-like response scale ranging from 0 (&quot;Not at all&quot;) to 4 (&quot;Very much&quot;). A total score is calculated as the sum of each score from items 1 to 39, which can range from 0 to 156. Negatively worded items are reverse scored (subtracted from 4) prior to summing so that higher total scores indicate better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale (version 4)</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>Fatigue was assessed with the 13-item FACIT-Fatigue scale (version 4). Each item has a 5-point Likert-like response scale ranging from 0 (&quot;Not at all&quot;) to 4 (&quot;Very much&quot;). A total score is calculated as the sum of each score from items 1 to 13, which can range from 0 to 52. Negatively worded items are reverse scored (subtracted from 4) prior to summing so that higher total scores indicate less experience of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Godin Leisure-Time Exercise questionnaire</measure>
    <time_frame>Adjusted mean difference between groups at 3-month and 6-month endpoints</time_frame>
    <description>The Godin Leisure-Time Exercise questionnaire was used to characterise levels of physical activity. The questionnaire contains three items and asks the patient to recall the number of bouts of strenuous, moderate, or mild physical activity that exceed 15 min in duration in which they have engaged in over a typical week. A total score is calculated by multiplying the number of strenuous, moderate, and mild physical activity bouts by weights of 9, 5, and 3, respectively, and summing those values in an overall score that ranges from 0 to 119 in arbitrary units. Higher scores indicate participation in higher levels of physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of recruited participants</measure>
    <time_frame>Descriptive statistics reported during the two-year recruitment period</time_frame>
    <description>Measured as the number of eligible participants who were eligible and consented to participate in the trial. This will be reported in a Consolidated Standards of Reporting Trials (CONSORT) participant flowchart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Descriptive statistics reported during the 3-month intervention period</time_frame>
    <description>The number of adverse events were recorded to determine the feasibility of the exercise intervention. An adverse event was defined as the occurrence of any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the exercise intervention. The type of adverse events was also noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition rate</measure>
    <time_frame>Descriptive statistics reported during the 3-month intervention period.</time_frame>
    <description>Established as the number of patients in the experimental group who discontinued the exercise intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who were lost to follow-up</measure>
    <time_frame>Descriptive statistics reported at 3-month and 6-month endpoints</time_frame>
    <description>In the experimental group, patients lost to follow-up were characterised as those who completed the exercise intervention but did not complete endpoint testing. In the control group, patients lost to follow-up were the number of patients who did not complete endpoint testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of exercise sessions completed</measure>
    <time_frame>Descriptive statistics reported during the 3-month intervention period</time_frame>
    <description>The number of exercise sessions completed by each participant in the intervention group was recorded. These values were than averaged to provide a measure of adherence. The maximum number of exercise sessions that participants could complete was 24, so adherence ranged from 0 to 24 sessions, with higher scores indicating greater adherence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group did not receive any supervised exercise or were not given any specific exercise recommendations during the trial period. However, patients in this group were offered the exercise intervention after completing the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care plus exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received standard care in addition to a 3-month exercise intervention upon initiating androgen deprivation therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care plus exercise</intervention_name>
    <description>The exercise was supervised by exercise science staff in the exercise science facilities at the University of East Anglia, UK. Participants competed two weekly sessions for 12 weeks upon initiating ADT. Each session lasted ~60 min and included aerobic interval exercise on a cycle ergometer (Monark 824E; Varberg, Sweden) followed by resistance training. In addition to the supervised exercise sessions, patients were advised on how to increase their habitual physical activity levels and were encouraged to engage in 30 minutes of self-directed exercise on three days each week (e.g. brisk walking, cycling, home-based resistance training).</description>
    <arm_group_label>Standard care plus exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Aged 50 to 80 years&#xD;
&#xD;
          -  Histologically confirmed stage I-IV prostate cancer&#xD;
&#xD;
          -  Scheduled for treatment with a luteinizing hormone-releasing hormone (LHRH) agonist&#xD;
             either alone or combined with radiotherapy&#xD;
&#xD;
          -  Anticipated to remain on androgen deprivation therapy (ADT) for at least the next 6&#xD;
             months&#xD;
&#xD;
          -  Willing and able to give written informed consent.&#xD;
&#xD;
          -  Understand written and verbal instructions in English&#xD;
&#xD;
          -  World Health Organisation (WHO) performance status 0 to 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously treated with ADT&#xD;
&#xD;
          -  Diagnosed or suspected metastatic bone disease&#xD;
&#xD;
          -  Absolute contraindications to exercise testing and training as defined by the American&#xD;
             College of Sports Medicine (ACSM, 2010)&#xD;
&#xD;
          -  Prior myocardial infarction or heart failure&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  Poorly controlled hypertension (≥ 200/110 mmHg)&#xD;
&#xD;
          -  Uncontrolled supraventricular tachycardia (≥ 100 bpm)&#xD;
&#xD;
          -  Pre-existing severe musculoskeletal, neurological or psychiatric condition that may&#xD;
             affect their ability to complete the testing battery or exercise training, as&#xD;
             determined by the patient's physician&#xD;
&#xD;
          -  Involvement in any other clinical trial or exercise trial&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Saxton, Saxton</last_name>
    <role>Study Director</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wilphard Ndjavera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norfolk and Norwich University Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <reference>
    <citation>Galvao DA, Taaffe DR, Spry N, Joseph D, Newton RU. Acute versus chronic exposure to androgen suppression for prostate cancer: impact on the exercise response. J Urol. 2011 Oct;186(4):1291-7. doi: 10.1016/j.juro.2011.05.055. Epub 2011 Aug 17.</citation>
    <PMID>21849187</PMID>
  </reference>
  <reference>
    <citation>Savastano S, Belfiore A, Di Somma C, Mauriello C, Rossi A, Pizza G, De Rosa A, Prestieri G, Angrisani L, Colao A. Validity of bioelectrical impedance analysis to estimate body composition changes after bariatric surgery in premenopausal morbidly women. Obes Surg. 2010 Mar;20(3):332-9. doi: 10.1007/s11695-009-0006-5. Epub 2009 Oct 28.</citation>
    <PMID>19862582</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Androgen deprivation therapy</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03776045/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03776045
org study id: PROSCARDIO1992
nct id: NCT03776045
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates whether exercise can reduce treatment-related adverse effects in
      prostate cancer patients initiating androgen deprivation therapy. Half of recruited
      participants completed a 3-month exercise intervention, while the other half did not perform
      any supervised exercise. It was anticipated that exercise would have a positive effect on
      body composition, cardiorespiratory fitness and quality of life.
Androgen deprivation therapy (ADT) is routinely used as first-line treatment for locally
      advanced and metastatic prostate cancer. However, it is associated with many side effects
      such as increased fat mass and reduced skeletal muscle mass, cardiorespiratory fitness and
      metabolic health. Ultimately, these negative changes induced by ADT contribute to reduced
      health-related quality of life (HRQoL). This study evaluates whether 3-months of exercise can
      mitigate treatment toxicity in prostate cancer patients initiating ADT.

      In a parallel groups, prospective, randomised controlled design, participants were randomly
      allocated to a standard care control group or standard care plus exercise group. The exercise
      group completed 3-months of combined aerobic and resistance training. The standard care group
      did not receive any supervised exercise or specific physical activity recommendations.
      Outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up)
      endpoints.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: After baseline measures were collected, participants were randomly allocated (1:1) to standard care or standard care plus exercise using a randomisation sequence created by an independent researcher (nQuery, Statistical Solutions, USA). Treatment allocation was concealed from the research team until after baseline measurements were collected.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Outcome assessors and data analysts were blind to treatment allocation. It was not possible to blind participants or the intervention facilitator.
measure: Whole body fat mass (kg)
time frame: Adjusted mean difference between groups at 3-month endpoint
description: Whole body fat mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This was chosen as the primary outcome because adiposity has shown a high propensity to increase during the initial phases of androgen deprivation therapy, more so than other measures (Galvao et al. 2011), which highlights the importance of targeting body fat at this stage of treatment.
measure: Whole body fat mass (kg)
time frame: Adjusted mean difference between groups at 6-month endpoint
description: Whole body fat mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This was chosen as the primary outcome because adiposity has shown a high propensity to increase during the initial phases of androgen deprivation therapy, more so than other measures (Galvao et al. 2011), which highlights the importance of targeting body fat at this stage of treatment.
measure: Whole body fat-free mass (kg)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Whole body fat-free mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This method is highly valid for measuring changes in body composition (Savastano et al. 2010).
measure: Anthropometric measurements (cm)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Waist, hip, mid-upper arm, forearm, mid-thigh and calf circumferences were measured with a non-stretching tape using standard techniques.
measure: Peak oxygen consumption (VO2peak, ml/kg/min)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Determined as the highest oxygen consumption (V̇O2) attained during the cardiopulmonary exercise test
measure: Ventilatory anaerobic threshold (ml/kg/min)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Estimated using the modified V-slope method and confirmed by evaluating ventilatory equivalents and end-tidal pressures. Two analysts independently determined the ventilatory anaerobic threshold, with discrepancies of ≥ 7.5% resolved through discussion and consultation with a third analyst if necessary.
measure: Ventilatory equivalents for O2 (V̇E/V̇O2) and CO2 (V̇E/V̇CO2)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Ratio of minute ventilation to O2 consumption and CO2 output at the ventilatory anaerobic threshold
measure: Oxygen pulse (ml/beat)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Ratio of oxygen consumption to heart rate at peak exercise during the cardiopulmonary exercise test
measure: Oxygen uptake efficiency slope (OUES)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Determined as the linear relationship between oxygen uptake and the logarithmic transformation of minute ventilation during the cardiopulmonary exercise test
measure: Concentration of cholesterol (mmol/L)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Concentrations of total cholesterol, low-density lipoprotein (LDL-C) and high-density lipoprotein (HDL-C) were measured from venous blood.
measure: Concentration of triglycerides (mmol/L)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: The concentration of triglycerides was measured from venous blood.
measure: Concentration of testosterone (nmol/L)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Concentration of total testosterone was measured from venous blood.
measure: Concentration of sex hormone binding globulin (nmol/L)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Concentration of sex hormone binding globulin was measured from venous blood.
measure: QRISK®2-2017 score
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: The percent risk of a cardiovascular disease event occurring in the next 10 years was calculated with QRISK®2-2017 Web Calculator (https://qrisk.org/2017). The total score ranges from 0 to 100 %, with higher scores indicating a greater risk of cardiovascular disease.
measure: Gleason score
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Gleason scores were measured from prostate biopsies. A score of 1 to 5 is assigned to the cells that make up the largest area of the tumor and another score of 1 to 5 is assigned to the cells that comprise the next largest area. A total Gleason score is then calculated by adding both of these scores together. Total scores ranged from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.
measure: Prostate specific antigen (ng/mL)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Concentration of prostate specific antigen was measured from venous blood.
measure: Skinfold thickness (mm)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Skinfold thickness was measured at suprailiac and subscapular sites with a skinfold caliper (Harpenden Skinfold Caliper, Baty International, Sussex, UK).
measure: Hand grip strength (kg)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Hand grip strength was measured with an analogue dynamometer (Takei Scientific Instruments Ltd., Tokyo, Japan).
measure: The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (version 4)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Disease-specific health-related quality of life was assessed with the FACT-P 39-item questionnaire (version 4). Each item has a 5-point Likert-like response scale ranging from 0 ("Not at all") to 4 ("Very much"). A total score is calculated as the sum of each score from items 1 to 39, which can range from 0 to 156. Negatively worded items are reverse scored (subtracted from 4) prior to summing so that higher total scores indicate better health-related quality of life.
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale (version 4)
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: Fatigue was assessed with the 13-item FACIT-Fatigue scale (version 4). Each item has a 5-point Likert-like response scale ranging from 0 ("Not at all") to 4 ("Very much"). A total score is calculated as the sum of each score from items 1 to 13, which can range from 0 to 52. Negatively worded items are reverse scored (subtracted from 4) prior to summing so that higher total scores indicate less experience of fatigue.
measure: Godin Leisure-Time Exercise questionnaire
time frame: Adjusted mean difference between groups at 3-month and 6-month endpoints
description: The Godin Leisure-Time Exercise questionnaire was used to characterise levels of physical activity. The questionnaire contains three items and asks the patient to recall the number of bouts of strenuous, moderate, or mild physical activity that exceed 15 min in duration in which they have engaged in over a typical week. A total score is calculated by multiplying the number of strenuous, moderate, and mild physical activity bouts by weights of 9, 5, and 3, respectively, and summing those values in an overall score that ranges from 0 to 119 in arbitrary units. Higher scores indicate participation in higher levels of physical activity.
measure: Number of recruited participants
time frame: Descriptive statistics reported during the two-year recruitment period
description: Measured as the number of eligible participants who were eligible and consented to participate in the trial. This will be reported in a Consolidated Standards of Reporting Trials (CONSORT) participant flowchart.
measure: Number of adverse events
time frame: Descriptive statistics reported during the 3-month intervention period
description: The number of adverse events were recorded to determine the feasibility of the exercise intervention. An adverse event was defined as the occurrence of any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the exercise intervention. The type of adverse events was also noted.
measure: Attrition rate
time frame: Descriptive statistics reported during the 3-month intervention period.
description: Established as the number of patients in the experimental group who discontinued the exercise intervention
measure: Number of patients who were lost to follow-up
time frame: Descriptive statistics reported at 3-month and 6-month endpoints
description: In the experimental group, patients lost to follow-up were characterised as those who completed the exercise intervention but did not complete endpoint testing. In the control group, patients lost to follow-up were the number of patients who did not complete endpoint testing.
measure: Average number of exercise sessions completed
time frame: Descriptive statistics reported during the 3-month intervention period
description: The number of exercise sessions completed by each participant in the intervention group was recorded. These values were than averaged to provide a measure of adherence. The maximum number of exercise sessions that participants could complete was 24, so adherence ranged from 0 to 24 sessions, with higher scores indicating greater adherence.
arm group label: Standard care
arm group type: No Intervention
description: This group did not receive any supervised exercise or were not given any specific exercise recommendations during the trial period. However, patients in this group were offered the exercise intervention after completing the study.
arm group label: Standard care plus exercise
arm group type: Experimental
description: This group received standard care in addition to a 3-month exercise intervention upon initiating androgen deprivation therapy.
intervention type: Other
intervention name: Standard care plus exercise
description: The exercise was supervised by exercise science staff in the exercise science facilities at the University of East Anglia, UK. Participants competed two weekly sessions for 12 weeks upon initiating ADT. Each session lasted ~60 min and included aerobic interval exercise on a cycle ergometer (Monark 824E; Varberg, Sweden) followed by resistance training. In addition to the supervised exercise sessions, patients were advised on how to increase their habitual physical activity levels and were encouraged to engage in 30 minutes of self-directed exercise on three days each week (e.g. brisk walking, cycling, home-based resistance training).
arm group label: Standard care plus exercise
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: John Saxton, Saxton
role: Study Director
affiliation: Northumbria University
last name: Wilphard Ndjavera, MD
role: Principal Investigator
affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust
citation: Galvao DA, Taaffe DR, Spry N, Joseph D, Newton RU. Acute versus chronic exposure to androgen suppression for prostate cancer: impact on the exercise response. J Urol. 2011 Oct;186(4):1291-7. doi: 10.1016/j.juro.2011.05.055. Epub 2011 Aug 17.
PMID: 21849187
citation: Savastano S, Belfiore A, Di Somma C, Mauriello C, Rossi A, Pizza G, De Rosa A, Prestieri G, Angrisani L, Colao A. Validity of bioelectrical impedance analysis to estimate body composition changes after bariatric surgery in premenopausal morbidly women. Obes Surg. 2010 Mar;20(3):332-9. doi: 10.1007/s11695-009-0006-5. Epub 2009 Oct 28.
PMID: 19862582
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No
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