<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/NCT04484714</url>
  </required_header>
  <id_info>
    <org_study_id>HREBA.CC-20-0201</org_study_id>
    <nct_id>NCT04484714</nct_id>
  </id_info>
  <brief_title>Virtual Exercise for Multiple Myeloma</brief_title>
  <acronym>MY-PROGRESS</acronym>
  <official_title>Feasibility of a Virtually Supported Home-Based Resistance and Aerobic Exercise Program for Cancer Survivors With Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this pilot study is to determine the safety and feasibility a&#xD;
      12-week virtually supported home-based aerobic and resistance exercise program progressing&#xD;
      cancer survivors with Multiple Myeloma to meet standards identified in the 2019 Exercise&#xD;
      Guidelines for Cancer Survivors.&#xD;
&#xD;
      The protocol will be measuring recruitment, adherence, completion, cost tracking, as well as&#xD;
      fitness and quality of life outcomes. The study will be a single-group prospective before and&#xD;
      after study that will help inform a future larger-scale project. We will aim to recruit 25&#xD;
      participants.&#xD;
&#xD;
      The Health Research Ethics Board of Alberta Cancer Committee will approve this study.&#xD;
      Participants will participate in a combined resistance and aerobic exercise program biweekly&#xD;
      for 12 weeks. Exercise sessions will be supported and progressive in nature, between 40 and&#xD;
      75 minutes each.&#xD;
&#xD;
      Analyses: fitness testing and quality of life scales will be administered before and after&#xD;
      the intervention. Scores will be compared to evaluate changes over the course of the&#xD;
      intervention. Safety and feasibility information will be collected throughout the study and&#xD;
      evaluated to determine program feasibility. Program satisfaction will be evaluated using a&#xD;
      satisfaction survey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple myeloma (MM), a cancer of the plasma cells in bone marrow, is associated with&#xD;
      osteolytic bone destruction, leading to deformities, chronic pain, reduced mobility and&#xD;
      functioning, fatigue, and risk of fracture. Although incurable, newly developed therapies are&#xD;
      extending survival, but some with significant side-effects. Patients may be living longer but&#xD;
      with lasting, debilitating side-effects.&#xD;
&#xD;
      Exercise has been proposed as a way to optimize patient function and quality of life in the&#xD;
      face of lasting symptom burden. However, current evidence-informed exercise guidelines for&#xD;
      cancer survivors may not be appropriate for those with bone fragility, including those with&#xD;
      MM, as they are based on findings from studies in breast and prostate cancers. In MM&#xD;
      specifically, the literature presents mixed results, and several studies have limited&#xD;
      generalizability, reproducibility, or were underdosed.&#xD;
&#xD;
      The main objective of this study is to determine the safety and feasibility of a 12-week&#xD;
      virtually supported home-based aerobic and resistance exercise program that aims to progress&#xD;
      individuals to the 2019 Exercise Guidelines for Cancer Survivors in a sample of cancer&#xD;
      survivors with multiple myeloma, as defined by:&#xD;
&#xD;
        -  Recruitment rate: ≥ 21 participants consenting to the study over a 7-month recruitment&#xD;
           period (primary endpoint)&#xD;
&#xD;
        -  Completion rate: ≥ 80% of participants consenting to the study complete the 12-week&#xD;
           assessment&#xD;
&#xD;
        -  Safety: no increase in the rate of bony events above those estimated to occur in the&#xD;
           target population&#xD;
&#xD;
        -  Adherence: average completion of ≥ 75% of the exercise prescription amongst participants&#xD;
&#xD;
      We will aim to recruit 25 participants from clinics at the local cancer hospital, the local&#xD;
      disease-group support society, and from the currently accruing Alberta Cancer Exercise&#xD;
      program. Subjects will be screened for eligibility and if they meet all eligibility criteria,&#xD;
      an information letter of the study will be provided, and they will be asked to contact the&#xD;
      investigators if interested in taking part in the study. All participants will be required to&#xD;
      provide written informed consent as per the Health Research Ethics Board of Alberta: Cancer&#xD;
      Committee (HREBA).&#xD;
&#xD;
      Participants will participate in a 12-week virtually supported home-based aerobic and&#xD;
      resistance exercise program, twice weekly using the Heal-Me application. Sessions will be&#xD;
      completed as virtual live classes or supported follow-along independent home workouts.&#xD;
      Sessions will progress in duration and difficulty over the course of the program, aiming to&#xD;
      have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the&#xD;
      program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio&#xD;
      circuit), and a full-body resistance training routine using free weights, body weight&#xD;
      exercises, and/or bands, followed by balance and stretching exercises.&#xD;
&#xD;
      Analyses: Demographic and medical information will be presented using median and range and&#xD;
      percentage for interval and nominal data, respectively. Descriptive statistics (mean ± SD and&#xD;
      frequencies) will be used to report safety and feasibility measures. Adherence will be&#xD;
      tracked as the percentage of total training load prescribed that was actually completed.&#xD;
      Wilcoxon Signed Rank Tests will be used to compare and pre- and post-intervention fitness&#xD;
      assessment and quality of life scores. All analyses will be conducted using Stata/MP (version&#xD;
      13.0, StataCorp LLC, College Station, TX), with alpha set to 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group before and after</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility (Adherence)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percentage of total exercise dose prescribed that was actually completed (%)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility (Recruitment rate)</measure>
    <time_frame>7 months</time_frame>
    <description>The number of participants recruited per month over the recruitment period and the proportion of patients who participate in the study, out of the total number of eligible patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility (Completion rate)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of participants who completed the program and follow-up assessment out of the number of participants who consented to the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility (Safety)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of adverse events reported by the participants during program participation, including the 12-week program and fitness assessments</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Home-based Stepping Test</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in 2-minute stepping test (number of steps)</description>
  </other_outcome>
  <other_outcome>
    <measure>Shoulder flexibility</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in active shoulder flexion range of motion (degrees)</description>
  </other_outcome>
  <other_outcome>
    <measure>Lower Body Flexibility</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in sit-and-reach test (cm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Leg Strength</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in 30-second sit-to-stand (number of repetitions)</description>
  </other_outcome>
  <other_outcome>
    <measure>Balance</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in one legged stance test (seconds</description>
  </other_outcome>
  <other_outcome>
    <measure>Balance Confidence</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Activities-specific Balance Confidence (ABC) scale (score)</description>
  </other_outcome>
  <other_outcome>
    <measure>Upper Extremity Function</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in Upper Extremity Functional Index (score)</description>
  </other_outcome>
  <other_outcome>
    <measure>Lower Extremity Function</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in Lower Extremity Functional Scale (score)</description>
  </other_outcome>
  <other_outcome>
    <measure>Cancer-Specific Quality of Life</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in Functional Assessment of Cancer Therapy General, Multiple Myeloma, and Bone Pain Scales (score)</description>
  </other_outcome>
  <other_outcome>
    <measure>Fatigue</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Change in FACIT-Fatigue Subscale (score)</description>
  </other_outcome>
  <other_outcome>
    <measure>Six-minute walk test (optional)</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Six-minute walk test distance (metres)</description>
  </other_outcome>
  <other_outcome>
    <measure>Upper Extremity Grip Strength (optional)</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Hand-grip dynamometry (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Upper extremity strength (optional)</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>One repetition maximum bench press (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Lower extremity strength (optional)</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>One repetition maximum leg press (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Core Endurance (optional)</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Plank hold (seconds)</description>
  </other_outcome>
  <other_outcome>
    <measure>Fall risk (optional)</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Three-metre backwards walk test (seconds)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Behavioural: Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take part in a twelve week resistance and aerobic exercise program twice per week delivered virtually.&#xD;
Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Participants will participate in a 12-week virtually supported home-based aerobic and resistance exercise program, twice weekly using the Heal-Me application. Sessions will be completed as virtual live classes or supported follow-along independent home workouts. Sessions will progress in duration and difficulty over the course of the program, aiming to have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio circuit), and a full-body resistance training routine using free weights, body weight exercises, and/or bands, followed by balance and stretching exercises.</description>
    <arm_group_label>Behavioural: Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age and older&#xD;
&#xD;
          2. Diagnosis of multiple myeloma&#xD;
&#xD;
          3. In one of the following three treatment categories:&#xD;
&#xD;
               -  Transplant ineligible patients, currently in first line treatment&#xD;
&#xD;
               -  Transplant eligible patients, sufficiently recovered from transplantation (&gt;3&#xD;
                  months following transplantation)&#xD;
&#xD;
               -  Patients with relapsed/recurrent myeloma with either 1-3 prior lines of treatment&#xD;
                  or 4+ prior lines&#xD;
&#xD;
          4. Able to provide informed written consent in English&#xD;
&#xD;
          5. Approved for physical activity participation by their oncologist and cleared for&#xD;
             physical activity by the Certified Exercise Physiologist on the PAR-Q+&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unstable cardiac/metabolic condition that would be deemed unsafe to exercise&#xD;
&#xD;
          2. Severe anemia&#xD;
&#xD;
          3. Spinal instability requiring surgical intervention&#xD;
&#xD;
          4. AL amyloidosis, solitary plasmacytoma, or Waldenstrom macroglobulinemia&#xD;
&#xD;
          5. Too frail to participate in home exercise, as determine by baseline physical&#xD;
             assessment (i.e., unable to complete a single sit-to-stand or balance on one foot for&#xD;
             ≥ 3 seconds).&#xD;
&#xD;
          6. Inability to provide consent&#xD;
&#xD;
          7. Inability to commit to, and/or comply with the intervention due to personal reasons&#xD;
             (e.g. vacation planned during the intervention period)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alberta/ Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>pilot</keyword>
  <keyword>feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>No plan in place at this time</ipd_description>
  </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/NCT04484714
org study id: HREBA.CC-20-0201
nct id: NCT04484714
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this pilot study is to determine the safety and feasibility a
      12-week virtually supported home-based aerobic and resistance exercise program progressing
      cancer survivors with Multiple Myeloma to meet standards identified in the 2019 Exercise
      Guidelines for Cancer Survivors.

      The protocol will be measuring recruitment, adherence, completion, cost tracking, as well as
      fitness and quality of life outcomes. The study will be a single-group prospective before and
      after study that will help inform a future larger-scale project. We will aim to recruit 25
      participants.

      The Health Research Ethics Board of Alberta Cancer Committee will approve this study.
      Participants will participate in a combined resistance and aerobic exercise program biweekly
      for 12 weeks. Exercise sessions will be supported and progressive in nature, between 40 and
      75 minutes each.

      Analyses: fitness testing and quality of life scales will be administered before and after
      the intervention. Scores will be compared to evaluate changes over the course of the
      intervention. Safety and feasibility information will be collected throughout the study and
      evaluated to determine program feasibility. Program satisfaction will be evaluated using a
      satisfaction survey.
Multiple myeloma (MM), a cancer of the plasma cells in bone marrow, is associated with
      osteolytic bone destruction, leading to deformities, chronic pain, reduced mobility and
      functioning, fatigue, and risk of fracture. Although incurable, newly developed therapies are
      extending survival, but some with significant side-effects. Patients may be living longer but
      with lasting, debilitating side-effects.

      Exercise has been proposed as a way to optimize patient function and quality of life in the
      face of lasting symptom burden. However, current evidence-informed exercise guidelines for
      cancer survivors may not be appropriate for those with bone fragility, including those with
      MM, as they are based on findings from studies in breast and prostate cancers. In MM
      specifically, the literature presents mixed results, and several studies have limited
      generalizability, reproducibility, or were underdosed.

      The main objective of this study is to determine the safety and feasibility of a 12-week
      virtually supported home-based aerobic and resistance exercise program that aims to progress
      individuals to the 2019 Exercise Guidelines for Cancer Survivors in a sample of cancer
      survivors with multiple myeloma, as defined by:

        -  Recruitment rate: ≥ 21 participants consenting to the study over a 7-month recruitment
           period (primary endpoint)

        -  Completion rate: ≥ 80% of participants consenting to the study complete the 12-week
           assessment

        -  Safety: no increase in the rate of bony events above those estimated to occur in the
           target population

        -  Adherence: average completion of ≥ 75% of the exercise prescription amongst participants

      We will aim to recruit 25 participants from clinics at the local cancer hospital, the local
      disease-group support society, and from the currently accruing Alberta Cancer Exercise
      program. Subjects will be screened for eligibility and if they meet all eligibility criteria,
      an information letter of the study will be provided, and they will be asked to contact the
      investigators if interested in taking part in the study. All participants will be required to
      provide written informed consent as per the Health Research Ethics Board of Alberta: Cancer
      Committee (HREBA).

      Participants will participate in a 12-week virtually supported home-based aerobic and
      resistance exercise program, twice weekly using the Heal-Me application. Sessions will be
      completed as virtual live classes or supported follow-along independent home workouts.
      Sessions will progress in duration and difficulty over the course of the program, aiming to
      have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the
      program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio
      circuit), and a full-body resistance training routine using free weights, body weight
      exercises, and/or bands, followed by balance and stretching exercises.

      Analyses: Demographic and medical information will be presented using median and range and
      percentage for interval and nominal data, respectively. Descriptive statistics (mean ± SD and
      frequencies) will be used to report safety and feasibility measures. Adherence will be
      tracked as the percentage of total training load prescribed that was actually completed.
      Wilcoxon Signed Rank Tests will be used to compare and pre- and post-intervention fitness
      assessment and quality of life scores. All analyses will be conducted using Stata/MP (version
      13.0, StataCorp LLC, College Station, TX), with alpha set to 0.05.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group before and after
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility (Adherence)
time frame: 12 weeks
description: The percentage of total exercise dose prescribed that was actually completed (%)
measure: Feasibility (Recruitment rate)
time frame: 7 months
description: The number of participants recruited per month over the recruitment period and the proportion of patients who participate in the study, out of the total number of eligible patients
measure: Feasibility (Completion rate)
time frame: 12 weeks
description: The number of participants who completed the program and follow-up assessment out of the number of participants who consented to the study
measure: Feasibility (Safety)
time frame: 12 weeks
description: The number of adverse events reported by the participants during program participation, including the 12-week program and fitness assessments
measure: Home-based Stepping Test
time frame: Change from baseline to 12 weeks
description: Change in 2-minute stepping test (number of steps)
measure: Shoulder flexibility
time frame: Change from baseline to 12 weeks
description: Change in active shoulder flexion range of motion (degrees)
measure: Lower Body Flexibility
time frame: Change from baseline to 12 weeks
description: Change in sit-and-reach test (cm)
measure: Leg Strength
time frame: Change from baseline to 12 weeks
description: Change in 30-second sit-to-stand (number of repetitions)
measure: Balance
time frame: Change from baseline to 12 weeks
description: Change in one legged stance test (seconds
measure: Balance Confidence
time frame: Change from baseline to 12 weeks
description: Activities-specific Balance Confidence (ABC) scale (score)
measure: Upper Extremity Function
time frame: Change from baseline to 12 weeks
description: Change in Upper Extremity Functional Index (score)
measure: Lower Extremity Function
time frame: Change from baseline to 12 weeks
description: Change in Lower Extremity Functional Scale (score)
measure: Cancer-Specific Quality of Life
time frame: Change from baseline to 12 weeks
description: Change in Functional Assessment of Cancer Therapy General, Multiple Myeloma, and Bone Pain Scales (score)
measure: Fatigue
time frame: Change from baseline to 12 weeks
description: Change in FACIT-Fatigue Subscale (score)
measure: Six-minute walk test (optional)
time frame: Change from baseline to 12 weeks
description: Six-minute walk test distance (metres)
measure: Upper Extremity Grip Strength (optional)
time frame: Change from baseline to 12 weeks
description: Hand-grip dynamometry (kg)
measure: Upper extremity strength (optional)
time frame: Change from baseline to 12 weeks
description: One repetition maximum bench press (kg)
measure: Lower extremity strength (optional)
time frame: Change from baseline to 12 weeks
description: One repetition maximum leg press (kg)
measure: Core Endurance (optional)
time frame: Change from baseline to 12 weeks
description: Plank hold (seconds)
measure: Fall risk (optional)
time frame: Change from baseline to 12 weeks
description: Three-metre backwards walk test (seconds)
arm group label: Behavioural: Exercise
arm group type: Experimental
description: Participants will take part in a twelve week resistance and aerobic exercise program twice per week delivered virtually.
Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises
intervention type: Behavioral
intervention name: Exercise
description: Participants will participate in a 12-week virtually supported home-based aerobic and resistance exercise program, twice weekly using the Heal-Me application. Sessions will be completed as virtual live classes or supported follow-along independent home workouts. Sessions will progress in duration and difficulty over the course of the program, aiming to have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio circuit), and a full-body resistance training routine using free weights, body weight exercises, and/or bands, followed by balance and stretching exercises.
arm group label: Behavioural: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: Undecided
ipd description: No plan in place at this time