<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/NCT03797378</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002645</org_study_id>
    <nct_id>NCT03797378</nct_id>
  </id_info>
  <brief_title>Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study</brief_title>
  <acronym>M2M LEADERS</acronym>
  <official_title>The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lakeshore Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>YMCA of Greater Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</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 purpose of this study is to test the effects of an innovative exercise program referred&#xD;
      to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility&#xD;
      disabilities. One hundred and eight participants with physical/mobility disabilities will be&#xD;
      recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The&#xD;
      primary aim of this study is to determine the effects of a 12-week M2M program on health and&#xD;
      fitness in participants with physical/mobility disabilities who are in one of three&#xD;
      functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II -&#xD;
      able to exercise sitting and standing with/without support, and 3) Group III - able to&#xD;
      exercise one side of the body more than the other side. The second aim is to compare the&#xD;
      observed effects of the program in this study to a previous M2M study that groups&#xD;
      participants based on disability type. The third aim of this study is to test whether&#xD;
      adherence (defined as attendance to the 12-week program) affects the effects of M2M in&#xD;
      participants with physical/mobility disabilities. The potential influences of different&#xD;
      functional mobility and disabilities of participants on how the program affects participants'&#xD;
      health and fitness outcomes will also be tested.&#xD;
&#xD;
      **In response to COVID-19, the 12-week M2M intervention and all assessments have been&#xD;
      modified from being delivered in-person at Lakeshore Foundation to being delivered remotely&#xD;
      in real-time through videoconferencing technology.**&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed intervention efficacy trial examines a remotely-delivered, rhythmic-based&#xD;
      movement-2-music (eM2M) intervention with 108 adults with physical/mobility disabilities who&#xD;
      are randomized into one of two groups: a) eM2M or b) waitlist control. The primary aim is to&#xD;
      determine the effects of a 12-week eM2M intervention on physical and psychosocial health&#xD;
      outcomes in participants with physical/mobility disabilities who are classified into three&#xD;
      functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II -&#xD;
      able to exercise sitting and standing with/without support, and 3) Group III - able to&#xD;
      exercise one side of the body more than the other side. The secondary aim is to compare&#xD;
      effect sizes of the physical health outcomes including cardiorespiratory fitness, muscle&#xD;
      strength and lower extremity function obtained in the current study to a previous M2M trial&#xD;
      that grouped participants based on disability type. The tertiary aim of this study is to&#xD;
      explore whether adherence (defined in terms of attendance to the 12-week intervention)&#xD;
      moderates effects of eM2M in participants with physical/mobility disabilities. The&#xD;
      heterogeneity of treatment effect across the physical health outcomes will also be examined&#xD;
      using functional mobility and disability groups as moderators.&#xD;
&#xD;
      Participants will complete a set of assessments at baseline and after the 12-week&#xD;
      intervention period remotely through videoconferencing technology. They will also be asked to&#xD;
      complete the questionnaire portion of the assessments every 6 months and the entire set of&#xD;
      assessments every year for up to 5 years. The assessments include cardiorespiratory fitness&#xD;
      measured using a heart rate recovery test, grip strength measured using hand-held&#xD;
      dynamometer, lower extremity function measured using the Short Physical Performance Battery&#xD;
      and the Timed Up and Go test as well as questionnaires that assess health-related quality of&#xD;
      life (NIH PROMIS 10 Global Health Items, NIH PROMIS Ability to Participate in Social Roles&#xD;
      and Activities), physical activity (Godin Leisure Time Exercise Questionnaire), exercise&#xD;
      self-efficacy (Exercise Self-efficacy Scale), exercise goal-setting (Exercise Goal-setting&#xD;
      Scale), outcome expectation for exercise (Multidimensional Outcomes Expectations for Exercise&#xD;
      Scale), social support (Social Provision Scale) and barriers in physical activity (Barriers&#xD;
      in Physical Activity Questionnaire). In addition, at the end of the 12-week intervention,&#xD;
      participants will be interviewed about their study experience and perceived impact of eM2M on&#xD;
      their fitness and health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 9, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Actual">May 25, 2023</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline cardiorespiratory fitness at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>The cardiorespiratory fitness is measured using a heart rate recovery test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline muscle strength at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Muscle strength is measured with grip strength using a hand-held dynamometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline lower extremity function at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Lower extremity function is assessed using the Short Physical Performance Battery (SPPB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline lower extremity function at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Lower extremity function will be assessed using the Timed Up and Go (TUG) test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline health-related quality of life at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Health-related quality of life is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Items. The instrument is a 10-item measure with the response scores ranging from 1 (very severe) to 5 (none). Two summary scores, a global physical health score and a global mental health score, can be calculated from this scale, with each score ranging from 4 to 20. Higher scores indicate better health. The total raw score is translated into a T-score for each participant for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline social participation at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Social participation is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline physical activity at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Physical activity is measured using the Godin Leisure Time Exercise Questionnaire. The questionnaire contains two questions. The first question asks participants to report weekly frequencies of activities they perform at different intensities. A total weekly leisure activity is a sum of activity scores calculated by multiplying the weekly frequencies of strenuous, moderate, and light activities by 9, 5, and 3, respectively. The second question asks participants the frequency of weekly leisure-time activities performed that are long enough to work up a sweat.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline barriers in physical activity at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Barriers in physical activity will be assessed using the Barriers in Physical Activity Questionnaire. The instrument contains 43 items. Each item is responded with either no (1) or yes (2). If response is yes, a follow-up response that ranges from 1 (very small) to 5 (very large) is selected. There are 8 domains, which include personal health, attitudes/beliefs towards physical activity, friends, family, fitness center built environment, policy/programs/staff, community built environment, and safety. Each domain score is calculated by summing the item responses with its respective item weight. Higher domain scores indicate greater perceived barriers to physical activity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline exercise self-efficacy at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Exercise self-efficacy will be assessed using the Exercise Self-Efficacy Scale. The scale contains 8 items, with response options of each item ranging from 0% (not at all confident) to 100% (highly confident). All items are summed and a mean score is calculated. Higher scores indicate higher levels of self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline exercise goal-setting at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Exercise goal-setting will be measured using the Exercise Goal-Setting Scale. The instrument contains 10 items with response options ranging from 1 (does not describe) to 5 (describes completely). A mean score is calculated. A higher mean score indicate better goal-setting and self-monitoring for exercise.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline outcome expectations for exercise at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Outcome expectations for exercise will be assessed using the Multidimensional Outcome Expectations for Exercise Scale. The instrument contains 15 items, with the response options ranging from 1 (strongly disagree) to 5 (strongly agree). Three domains of outcome expectations for exercise are assessed, which include physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items). Each dimension is scored by summing the item responses. Higher scores indicate higher levels of outcome expectations for exercise.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline social support at 3 months</measure>
    <time_frame>Baseline and post 12-week intervention</time_frame>
    <description>Social support will be assessed using the Social Provision Scale. The instrument contains 24 items, with the response options ranging from 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing scores from all items. A higher score indicates a greater degree of perceived support.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <condition>Traumatic Brain Injury</condition>
  <condition>Spina Bifida</condition>
  <condition>Cerebral Palsy</condition>
  <condition>Stroke</condition>
  <condition>Parkinson Disease</condition>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>eM2M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the eM2M arm will participate in an intervention that involves three 60-minute M2M sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. At the beginning and end of each session, vital signs (heart rate, blood pressure and peripheral capillary oxygen saturation) are obtained from participants. Participants rate perceived exertion, pain, and fatigue level on a log. Participants set weekly exercise goals and expectations at first session of each week. Participants also record daily activities using a provided log.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the waitlist control arm are instructed to maintain their usual activities during the 12-week intervention period and are asked to record their activities on a provided log.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>eM2M</intervention_name>
    <description>The eM2M intervention involves three 60-minute sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. The intervention uses combinations of movement patterns that target range of motion, muscle strength, cardiorespiratory fitness, balance, and breathing. Each session consists of movement routines choreographed to music, and every routine can be adapted to participants' functional ability.</description>
    <arm_group_label>eM2M</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis of head injury, stroke, multiple sclerosis, spinal cord injury,&#xD;
             spina bifida, Parkinson disease, cerebral palsy by a physician&#xD;
&#xD;
          -  Able to use upper limbs and/or lower limbs to exercise and follow instructions&#xD;
&#xD;
          -  Physician clearance to participate&#xD;
&#xD;
          -  Willing to participate in an exercise program three times per week&#xD;
&#xD;
          -  Conversant in and reads English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participate in an exercise intervention or a similar intervention in the last 6 months&#xD;
&#xD;
          -  Current smoker or recently quit less than 6 months prior&#xD;
&#xD;
          -  Cognitive impairment (Folstein's Mini-Mental State Exam score &lt;24)&#xD;
&#xD;
          -  Presence of active pressure ulcer&#xD;
&#xD;
          -  Any contraindications to exercise based on the American College of Sports Medicine&#xD;
             (ACSM) guidelines&#xD;
&#xD;
          -  Visual acuity that prevents following a group exercise class&#xD;
&#xD;
          -  Significant hearing impairment impeding ability to hear music to engage in exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UAB Research Collaborative</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>May 27, 2023</last_update_submitted>
  <last_update_submitted_qc>May 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>James Rimmer</investigator_full_name>
    <investigator_title>Lakeshore Foundation Endowed Chair in Health Promotion and Rehabilitation Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Spinal Dysraphism</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT03797378
org study id: IRB-300002645
nct id: NCT03797378
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the effects of an innovative exercise program referred
      to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility
      disabilities. One hundred and eight participants with physical/mobility disabilities will be
      recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The
      primary aim of this study is to determine the effects of a 12-week M2M program on health and
      fitness in participants with physical/mobility disabilities who are in one of three
      functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II -
      able to exercise sitting and standing with/without support, and 3) Group III - able to
      exercise one side of the body more than the other side. The second aim is to compare the
      observed effects of the program in this study to a previous M2M study that groups
      participants based on disability type. The third aim of this study is to test whether
      adherence (defined as attendance to the 12-week program) affects the effects of M2M in
      participants with physical/mobility disabilities. The potential influences of different
      functional mobility and disabilities of participants on how the program affects participants'
      health and fitness outcomes will also be tested.

      **In response to COVID-19, the 12-week M2M intervention and all assessments have been
      modified from being delivered in-person at Lakeshore Foundation to being delivered remotely
      in real-time through videoconferencing technology.**
The proposed intervention efficacy trial examines a remotely-delivered, rhythmic-based
      movement-2-music (eM2M) intervention with 108 adults with physical/mobility disabilities who
      are randomized into one of two groups: a) eM2M or b) waitlist control. The primary aim is to
      determine the effects of a 12-week eM2M intervention on physical and psychosocial health
      outcomes in participants with physical/mobility disabilities who are classified into three
      functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II -
      able to exercise sitting and standing with/without support, and 3) Group III - able to
      exercise one side of the body more than the other side. The secondary aim is to compare
      effect sizes of the physical health outcomes including cardiorespiratory fitness, muscle
      strength and lower extremity function obtained in the current study to a previous M2M trial
      that grouped participants based on disability type. The tertiary aim of this study is to
      explore whether adherence (defined in terms of attendance to the 12-week intervention)
      moderates effects of eM2M in participants with physical/mobility disabilities. The
      heterogeneity of treatment effect across the physical health outcomes will also be examined
      using functional mobility and disability groups as moderators.

      Participants will complete a set of assessments at baseline and after the 12-week
      intervention period remotely through videoconferencing technology. They will also be asked to
      complete the questionnaire portion of the assessments every 6 months and the entire set of
      assessments every year for up to 5 years. The assessments include cardiorespiratory fitness
      measured using a heart rate recovery test, grip strength measured using hand-held
      dynamometer, lower extremity function measured using the Short Physical Performance Battery
      and the Timed Up and Go test as well as questionnaires that assess health-related quality of
      life (NIH PROMIS 10 Global Health Items, NIH PROMIS Ability to Participate in Social Roles
      and Activities), physical activity (Godin Leisure Time Exercise Questionnaire), exercise
      self-efficacy (Exercise Self-efficacy Scale), exercise goal-setting (Exercise Goal-setting
      Scale), outcome expectation for exercise (Multidimensional Outcomes Expectations for Exercise
      Scale), social support (Social Provision Scale) and barriers in physical activity (Barriers
      in Physical Activity Questionnaire). In addition, at the end of the 12-week intervention,
      participants will be interviewed about their study experience and perceived impact of eM2M on
      their fitness and health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change from baseline cardiorespiratory fitness at 3 months
time frame: Baseline and post 12-week intervention
description: The cardiorespiratory fitness is measured using a heart rate recovery test
measure: Change from baseline muscle strength at 3 months
time frame: Baseline and post 12-week intervention
description: Muscle strength is measured with grip strength using a hand-held dynamometer.
measure: Change from baseline lower extremity function at 3 months
time frame: Baseline and post 12-week intervention
description: Lower extremity function is assessed using the Short Physical Performance Battery (SPPB)
measure: Change from baseline lower extremity function at 3 months
time frame: Baseline and post 12-week intervention
description: Lower extremity function will be assessed using the Timed Up and Go (TUG) test.
measure: Change from baseline health-related quality of life at 3 months
time frame: Baseline and post 12-week intervention
description: Health-related quality of life is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Items. The instrument is a 10-item measure with the response scores ranging from 1 (very severe) to 5 (none). Two summary scores, a global physical health score and a global mental health score, can be calculated from this scale, with each score ranging from 4 to 20. Higher scores indicate better health. The total raw score is translated into a T-score for each participant for analysis.
measure: Change from baseline social participation at 3 months
time frame: Baseline and post 12-week intervention
description: Social participation is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.
measure: Change from baseline physical activity at 3 months
time frame: Baseline and post 12-week intervention
description: Physical activity is measured using the Godin Leisure Time Exercise Questionnaire. The questionnaire contains two questions. The first question asks participants to report weekly frequencies of activities they perform at different intensities. A total weekly leisure activity is a sum of activity scores calculated by multiplying the weekly frequencies of strenuous, moderate, and light activities by 9, 5, and 3, respectively. The second question asks participants the frequency of weekly leisure-time activities performed that are long enough to work up a sweat.
measure: Change from baseline barriers in physical activity at 3 months
time frame: Baseline and post 12-week intervention
description: Barriers in physical activity will be assessed using the Barriers in Physical Activity Questionnaire. The instrument contains 43 items. Each item is responded with either no (1) or yes (2). If response is yes, a follow-up response that ranges from 1 (very small) to 5 (very large) is selected. There are 8 domains, which include personal health, attitudes/beliefs towards physical activity, friends, family, fitness center built environment, policy/programs/staff, community built environment, and safety. Each domain score is calculated by summing the item responses with its respective item weight. Higher domain scores indicate greater perceived barriers to physical activity.
measure: Change from baseline exercise self-efficacy at 3 months
time frame: Baseline and post 12-week intervention
description: Exercise self-efficacy will be assessed using the Exercise Self-Efficacy Scale. The scale contains 8 items, with response options of each item ranging from 0% (not at all confident) to 100% (highly confident). All items are summed and a mean score is calculated. Higher scores indicate higher levels of self-efficacy.
measure: Change from baseline exercise goal-setting at 3 months
time frame: Baseline and post 12-week intervention
description: Exercise goal-setting will be measured using the Exercise Goal-Setting Scale. The instrument contains 10 items with response options ranging from 1 (does not describe) to 5 (describes completely). A mean score is calculated. A higher mean score indicate better goal-setting and self-monitoring for exercise.
measure: Change from baseline outcome expectations for exercise at 3 months
time frame: Baseline and post 12-week intervention
description: Outcome expectations for exercise will be assessed using the Multidimensional Outcome Expectations for Exercise Scale. The instrument contains 15 items, with the response options ranging from 1 (strongly disagree) to 5 (strongly agree). Three domains of outcome expectations for exercise are assessed, which include physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items). Each dimension is scored by summing the item responses. Higher scores indicate higher levels of outcome expectations for exercise.
measure: Change from baseline social support at 3 months
time frame: Baseline and post 12-week intervention
description: Social support will be assessed using the Social Provision Scale. The instrument contains 24 items, with the response options ranging from 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing scores from all items. A higher score indicates a greater degree of perceived support.
arm group label: eM2M
arm group type: Experimental
description: Participants in the eM2M arm will participate in an intervention that involves three 60-minute M2M sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. At the beginning and end of each session, vital signs (heart rate, blood pressure and peripheral capillary oxygen saturation) are obtained from participants. Participants rate perceived exertion, pain, and fatigue level on a log. Participants set weekly exercise goals and expectations at first session of each week. Participants also record daily activities using a provided log.
arm group label: Waitlist Control
arm group type: No Intervention
description: Participants in the waitlist control arm are instructed to maintain their usual activities during the 12-week intervention period and are asked to record their activities on a provided log.
intervention type: Other
intervention name: eM2M
description: The eM2M intervention involves three 60-minute sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. The intervention uses combinations of movement patterns that target range of motion, muscle strength, cardiorespiratory fitness, balance, and breathing. Each session consists of movement routines choreographed to music, and every routine can be adapted to participants' functional ability.
arm group label: eM2M
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: James Rimmer
investigator title: Lakeshore Foundation Endowed Chair in Health Promotion and Rehabilitation Sciences
mesh term: Parkinson Disease
mesh term: Multiple Sclerosis
mesh term: Brain Injuries
mesh term: Spinal Cord Injuries
mesh term: Cerebral Palsy
mesh term: Brain Injuries, Traumatic
mesh term: Spinal Dysraphism
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)