<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/NCT03825913</url>
  </required_header>
  <id_info>
    <org_study_id>20180174</org_study_id>
    <nct_id>NCT03825913</nct_id>
  </id_info>
  <brief_title>3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma</brief_title>
  <official_title>Feasibility and Safety Profile of a 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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>
      Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month&#xD;
      exercise intervention among individuals diagnosed with melanoma.&#xD;
&#xD;
      The study will be conducted at University of Miami Miller School of Medicine. Eligible&#xD;
      participants (n=24) will be randomized into 3 months of wellness education (n=12) or&#xD;
      structured exercise (n=12).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month&#xD;
      exercise intervention among individuals diagnosed with melanoma.&#xD;
&#xD;
      The study will be conducted at University of Miami Miller School of Medicine. The eligible&#xD;
      participants will meet the following inclusion and exclusion criteria.&#xD;
&#xD;
      Inclusion criteria: (a) men and women (≥ 18 years of age) with melanoma cancer within one&#xD;
      year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150&#xD;
      minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week&#xD;
      for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions&#xD;
      or bi-monthly educational sessions for three months at University of Miami Miller School of&#xD;
      Medicine and (d) able to understand, read and write English.&#xD;
&#xD;
      Exclusion criteria: (a) participants for whom physical activity is contraindicated because of&#xD;
      comorbid conditions, (b) participants with dementia, altered mental status or psychiatric&#xD;
      condition and (c) participants who are unwilling or unable to provide informed consent.&#xD;
&#xD;
      The participants (n=24) will be randomized into 3 months of: 1) wellness education (n=12) or&#xD;
      2) structured exercise (n=12). All participants will receive standard treatment as directed&#xD;
      by their oncologists. Individuals in the wellness education group will attend bi-monthly&#xD;
      sessions where they will receive general wellness information pertaining to physical&#xD;
      activity, nutrition, sleep, weight management and mindfulness. Individuals in the structured&#xD;
      exercise group will attend supervised exercise sessions twice per week and receive a tailored&#xD;
      daily walking plan using physical activity trackers. A comprehensive assessment will be&#xD;
      conducted at baseline and 3-months, which will include demographics, medical and treatment&#xD;
      history, anthropometrics, quality of life, physical fitness, past and current sun exposure,&#xD;
      fatigue, and nutritional status. We plan the following specific aims:&#xD;
&#xD;
      Aim 1: To assess feasibility, adherence, and safety of a 3-month supervised exercise program&#xD;
      in melanoma patients.&#xD;
&#xD;
      Aim 2: To evaluate the impact of a 3-month supervised exercise program on quality of life in&#xD;
      melanoma patients.&#xD;
&#xD;
      Aim 3: To evaluate the effect of a 3-month supervised exercise program on cardiorespiratory&#xD;
      fitness and muscular strength in melanoma patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    two key faculty members are no longer part of the study and institution&#xD;
  </why_stopped>
  <start_date type="Actual">November 6, 2019</start_date>
  <completion_date type="Actual">February 21, 2020</completion_date>
  <primary_completion_date type="Actual">February 21, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility Assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>Less than 20% attrition rate for the intervention group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence Assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>80% or higher of the exercise sessions completed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FACT-M (Functional Assessment of Cancer Therapy - Melanoma)</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>Quality of Life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute Walk Test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cardiorespiratory Fitness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand Grip</measure>
    <time_frame>12 weeks</time_frame>
    <description>Muscular Strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-sec Chair Stand</measure>
    <time_frame>12 weeks</time_frame>
    <description>Functional Status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Frequency Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>Nutritional Intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SEBI (Sun Exposure and Behavior Inventory)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Sun Exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACIT (Functional Assessment of Chronic Illness Therapy</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>Fatigue</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the exercise group will participate in a 3-month exercise program at the University of Miami UHealth Fitness and Wellness Center. Participants will complete two exercise sessions a week, each 45-60 minutes long and on a one-on-one basis.&#xD;
In addition to two site visits, the participants will receive a tailored daily home-based walking plan. The participants will use physical activity trackers (Fitbit®), with an ultimate goal of achieving 10,000 steps by the end of the intervention.&#xD;
Participants in the exercise intervention will complete 24 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wellness Intervention</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>For 3 months, the wellness education group will not be offered any form of supervised exercise program or receive any specific instructions on physical activity as part of the study. The participants in this group will attend educational sessions about different wellness topics, such as nutrition, sleep, weight management, mindfulness, and the overall benefits of increased physical activity. The wellness visits will be held two times per month, and similar to the exercise sessions of the intervention arm, they will be 45-60 minutes long and on a one-on-one basis. Participants in the wellness education group will complete 6 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Training sessions will include a split routine based on the day of the week.&#xD;
Session 1 (e.g. Tuesday) - aerobic exercise (20-30 min) followed by resistance training (10 stacked-weight machines: leg press, leg extension, leg curl, chest press, latissimus pull, shoulder press, seated row, triceps press, biceps curl, and chest fly) for 1-2 sets of 8-12 repetitions.&#xD;
Session 2 (e.g. Thursday) - resistance bands and body weight exercises (4-6 exercises, 2 sets of 10-20 repetitions) followed by core exercises (2-3 sets of 10-20 repetitions) and aerobic training (20-30 min) at the end.&#xD;
The starting training intensities will be at 50-55% of each individual's estimated maximum heart rate for aerobic exercise and one-repetition maximum for resistance training (assessed at baseline only for chest press and leg press). We plan a 5% monthly increase in the intensity to reach 65-70%% of one's maximum efforts by the end of the intervention.</description>
    <arm_group_label>Exercise Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Intervention</intervention_name>
    <description>In our setting, ten lectures in nutrition, exercise and various complementary and integrative medicine topics (e.g. acupuncture and Chinese medicine, mindfulness, quality sleep, etc.) were implemented among non-cancer individuals and modified based on their feedback.</description>
    <arm_group_label>Wellness Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: (a) men and women (≥ 18 years of age) with a diagnosis of melanoma&#xD;
        cancer within one year from diagnosis, (b) not meeting the guidelines for physical activity&#xD;
        (less than 150 minutes of moderate intensity activity or 75 minutes of vigorous intensity&#xD;
        activity a week for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised&#xD;
        exercise sessions or bi-monthly educational sessions for three months at University of&#xD;
        Miami Miller School of Medicine (d) and able to understand, read and write English.&#xD;
&#xD;
        Exclusion criteria: (a) participants for whom physical activity is contraindicated because&#xD;
        of comorbid conditions, (b) participants with dementia, altered mental status or&#xD;
        psychiatric condition and (c) participants who are unwilling or unable to provide informed&#xD;
        consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduard Tiozzo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Eduard Tiozzo, PhD</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <keyword>Melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03825913
org study id: 20180174
nct id: NCT03825913
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month
      exercise intervention among individuals diagnosed with melanoma.

      The study will be conducted at University of Miami Miller School of Medicine. Eligible
      participants (n=24) will be randomized into 3 months of wellness education (n=12) or
      structured exercise (n=12).
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month
      exercise intervention among individuals diagnosed with melanoma.

      The study will be conducted at University of Miami Miller School of Medicine. The eligible
      participants will meet the following inclusion and exclusion criteria.

      Inclusion criteria: (a) men and women (≥ 18 years of age) with melanoma cancer within one
      year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150
      minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week
      for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions
      or bi-monthly educational sessions for three months at University of Miami Miller School of
      Medicine and (d) able to understand, read and write English.

      Exclusion criteria: (a) participants for whom physical activity is contraindicated because of
      comorbid conditions, (b) participants with dementia, altered mental status or psychiatric
      condition and (c) participants who are unwilling or unable to provide informed consent.

      The participants (n=24) will be randomized into 3 months of: 1) wellness education (n=12) or
      2) structured exercise (n=12). All participants will receive standard treatment as directed
      by their oncologists. Individuals in the wellness education group will attend bi-monthly
      sessions where they will receive general wellness information pertaining to physical
      activity, nutrition, sleep, weight management and mindfulness. Individuals in the structured
      exercise group will attend supervised exercise sessions twice per week and receive a tailored
      daily walking plan using physical activity trackers. A comprehensive assessment will be
      conducted at baseline and 3-months, which will include demographics, medical and treatment
      history, anthropometrics, quality of life, physical fitness, past and current sun exposure,
      fatigue, and nutritional status. We plan the following specific aims:

      Aim 1: To assess feasibility, adherence, and safety of a 3-month supervised exercise program
      in melanoma patients.

      Aim 2: To evaluate the impact of a 3-month supervised exercise program on quality of life in
      melanoma patients.

      Aim 3: To evaluate the effect of a 3-month supervised exercise program on cardiorespiratory
      fitness and muscular strength in melanoma patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility Assessment
time frame: 12 weeks
description: Less than 20% attrition rate for the intervention group
measure: Adherence Assessment
time frame: 12 weeks
description: 80% or higher of the exercise sessions completed
measure: FACT-M (Functional Assessment of Cancer Therapy - Melanoma)
time frame: 6 and 12 weeks
description: Quality of Life
measure: 6-minute Walk Test
time frame: 12 weeks
description: Cardiorespiratory Fitness
measure: Hand Grip
time frame: 12 weeks
description: Muscular Strength
measure: 30-sec Chair Stand
time frame: 12 weeks
description: Functional Status
measure: Food Frequency Questionnaire
time frame: 12 weeks
description: Nutritional Intake
measure: SEBI (Sun Exposure and Behavior Inventory)
time frame: 12 weeks
description: Sun Exposure
measure: FACIT (Functional Assessment of Chronic Illness Therapy
time frame: 6 and 12 weeks
description: Fatigue
arm group label: Exercise Intervention
arm group type: Active Comparator
description: Subjects in the exercise group will participate in a 3-month exercise program at the University of Miami UHealth Fitness and Wellness Center. Participants will complete two exercise sessions a week, each 45-60 minutes long and on a one-on-one basis.
In addition to two site visits, the participants will receive a tailored daily home-based walking plan. The participants will use physical activity trackers (Fitbit®), with an ultimate goal of achieving 10,000 steps by the end of the intervention.
Participants in the exercise intervention will complete 24 sessions.
arm group label: Wellness Intervention
arm group type: Sham Comparator
description: For 3 months, the wellness education group will not be offered any form of supervised exercise program or receive any specific instructions on physical activity as part of the study. The participants in this group will attend educational sessions about different wellness topics, such as nutrition, sleep, weight management, mindfulness, and the overall benefits of increased physical activity. The wellness visits will be held two times per month, and similar to the exercise sessions of the intervention arm, they will be 45-60 minutes long and on a one-on-one basis. Participants in the wellness education group will complete 6 sessions.
intervention type: Behavioral
intervention name: Exercise Intervention
description: Training sessions will include a split routine based on the day of the week.
Session 1 (e.g. Tuesday) - aerobic exercise (20-30 min) followed by resistance training (10 stacked-weight machines: leg press, leg extension, leg curl, chest press, latissimus pull, shoulder press, seated row, triceps press, biceps curl, and chest fly) for 1-2 sets of 8-12 repetitions.
Session 2 (e.g. Thursday) - resistance bands and body weight exercises (4-6 exercises, 2 sets of 10-20 repetitions) followed by core exercises (2-3 sets of 10-20 repetitions) and aerobic training (20-30 min) at the end.
The starting training intensities will be at 50-55% of each individual's estimated maximum heart rate for aerobic exercise and one-repetition maximum for resistance training (assessed at baseline only for chest press and leg press). We plan a 5% monthly increase in the intensity to reach 65-70%% of one's maximum efforts by the end of the intervention.
arm group label: Exercise Intervention
intervention type: Behavioral
intervention name: Wellness Intervention
description: In our setting, ten lectures in nutrition, exercise and various complementary and integrative medicine topics (e.g. acupuncture and Chinese medicine, mindfulness, quality sleep, etc.) were implemented among non-cancer individuals and modified based on their feedback.
arm group label: Wellness Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eduard Tiozzo, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Eduard Tiozzo, PhD
investigator title: Instructor
mesh term: Melanoma
sharing ipd: No