<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/NCT03283163</url>
  </required_header>
  <id_info>
    <org_study_id>D0704-W</org_study_id>
    <secondary_id>1k2 RX000704</secondary_id>
    <nct_id>NCT03283163</nct_id>
  </id_info>
  <brief_title>Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD</brief_title>
  <acronym>EXCPPTSD</acronym>
  <official_title>Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The wars in Iraq and Afghanistan are creating a new generation of Veterans, including an&#xD;
      increasing number of women Veterans, who present with comorbid PTSD and chronic pain&#xD;
      conditions from recent deployment-related physical injuries and exposure to psychological&#xD;
      trauma. Health behavior change has become increasingly important in treating these conditions&#xD;
      and proactively preventing long-term negative health sequelae, in order to benefit these&#xD;
      Veterans directly and reduce the growing challenges to our healthcare system. The proposed&#xD;
      CDA-2 program of research will use an innovative translational research approach to study&#xD;
      whether a chronic progressive -based exercise program will reduce chronic pain in patients&#xD;
      with PTSD and to elucidate and modify potential PTSD-related deficiencies in neurobiological&#xD;
      and psychological responses to exercise to optimize the physical and psychological benefits&#xD;
      of exercise for these individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Due to the COVID-19 pandemic, and after consultation with the appropriate research oversight,&#xD;
      all study procedures are temporarily suspended as of 3/15/20.&#xD;
&#xD;
      This study will explicitly compare the effects of a 12-week progressive exercise training&#xD;
      program on 1) the clinical symptoms of chronic pain and PTSD, 2) pain threshold and&#xD;
      tolerance, and 3) anti-stress, anti-nociceptive neurohormones such as neuropeptide Y (NPY)&#xD;
      and allopregnanolone/pregnanolone (ALLO) in Veterans with chronic pain/PTSD compared to&#xD;
      healthy comparison participants. The revised study design includes a baseline cardiopulmonary&#xD;
      exercise assessment (CPX) that will inform the exercise prescription for a 12-week&#xD;
      &quot;progressive exercise&quot; training program, comprised of three 30-45 minute exercise sessions&#xD;
      per week (walking or running, depending on the ability/capacity of the participant). Exercise&#xD;
      sessions will be initially supervised by an exercise physiologist in the Clinical Studies&#xD;
      Unit (CSU) at the VA Boston Healthcare System and then each participant will transition into&#xD;
      the home. Weekly telephone calls by the PI will provide additional motivational support and&#xD;
      assistance with problem solving. Implementation of the prescribed exercise regimen will also&#xD;
      be supported by the use of heart rate and actigraph monitors programmed for the participant&#xD;
      to achieve their prescribed heart rate range (HRR). Finally, an &quot;endpoint&quot; maximum load&#xD;
      exercise assessment will occur at week 13 in order to track measurable change for both&#xD;
      psychological and neurobiological factors and to delineate their impact on pain indices and&#xD;
      PTSD symptomatology. Both maximum load exercise tests will be performed in accordance with&#xD;
      guidelines published by the American College of Cardiology. Measures of pain, pain tolerance&#xD;
      (via the cold pressor test) will be implemented 30 minutes before and 30 minutes after&#xD;
      exercise testing as well as at a midpoint &quot;check-in&quot; at which self-report questionnaires will&#xD;
      also be repeated. Based on the PI's earlier research, the role of exercise motivation and&#xD;
      self-efficacy on changes in perceived pain and pain tolerance will be correlated with changes&#xD;
      in NPY and ALLO levels, pre and post exercise. It is anticipated that differences in&#xD;
      biological responses to aerobic and anaerobic exercise between healthy participants and those&#xD;
      with chronic pain/PTSD will predict differences in the psychological and pain-reducing&#xD;
      benefits of aerobic and anaerobic exercise. Once identified, such factors could be augmented&#xD;
      by modification of the exercise regimen in order to help enhance the ant-stress hormone&#xD;
      levels for the pain/PTSD population and experience clinically significant reductions in their&#xD;
      symptoms. In order to obtain sufficient power as well as accounting for an expected drop-out&#xD;
      rate of 18-20%, the proposed recruitment is 30 participants per condition (total of 60&#xD;
      participants). Data from this pilot work will be used to compute effect sizes in support of a&#xD;
      future clinical trial incorporating individually prescribed exercise regimens and a&#xD;
      motivationally based exercise behavior change intervention aimed at reducing pain and PTSD&#xD;
      symptoms in our Veterans. Advanced education and training is sought by this CDA-2 award&#xD;
      applicant in four broad areas: 1) psychophysiology of chronic pain and PTSD with a sub-focus&#xD;
      on sex differences, 2) the neurobiology of chronic stress, PTSD, and pain, 3) exercise&#xD;
      physiology and 4) the neuropsychology and neurobiology of traumatic brain injury (TBI). The&#xD;
      combination of didactic and experiential training in these areas will serve the PI's&#xD;
      long-term goal of becoming an independent scientist/practitioner in the VA focused on&#xD;
      development of improved treatments for health conditions co-morbid with PTSD such as chronic&#xD;
      pain and mild TBI. In the shorter-term, this CDA-2 will allow the PI to develop a more&#xD;
      effective, motivationally based, exercise behavior change protocol that fosters long-term&#xD;
      exercise compliance in patients with chronic pain/PTSD. This intervention will be used as an&#xD;
      adjunct to cognitive interventions for these disorders to be further developed and studied&#xD;
      via a larger VA, NIH, or DOD-funded grant for which the PI will apply in years 4-5 of the&#xD;
      CDA2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 1, 2013</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study includes two groups: Trauma-exposed healthy controls and individuals suffering from both chronic musculoskeletal pain and PTSD. Those who meet diagnostic criteria for Chronic pain and PTSD will be assigned to that group. Those who are trauma exposed and do not meet criteria for Chronic Pain and PTSD will be assigned to the trauma-exposed control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The endpoint assessor will have no knowledge of which study group the participant belongs to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline: Clinician Administered PTSD Scale -5</measure>
    <time_frame>Baseline and endpoint (at 13 weeks)</time_frame>
    <description>To be administered at: Screening Evaluation &amp; Endpoint 13 week exercise test sessions This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS-5 is currently in the process of being validated however its previous version demonstrated excellent sensitivity (.81) and specificity (.95).57</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline: West Haven=Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)</measure>
    <time_frame>Baseline, Midpoint (at 6 weeks) and Endpoint (at 13 weeks)</time_frame>
    <description>The WHY-MPI has been demonstrated to be applicable across a variety of clinical pain conditions. Its brevity, validity/ reliability, self-report nature and ease of scoring make it ideal for both clinical and research purposes. The WHY-MPI is sensitive to change following rehabilitation. Please note only the interference subscale of the WHY-MPI will be administered in this study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Chronic Musculoskeletal Pain</condition>
  <condition>Posttraumatic Stress Disorder (PTSD)</condition>
  <condition>Mild or Moderate Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Chronic Pain//PTSD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive baseline and endpoint maximum load exercise testing which will inform their individualized exercise prescription (based on a progressive methodology) of aerobic exercise training aimed at meeting specific heart rate ranges over time (increasing up to 80% of maximum HRR between the midpoint and endpoint (6-12 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trauma-exposed healthy control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive baseline and endpoint maximum load exercise testing which will inform their individualized exercise prescription (based on a progressive methodology) of aerobic exercise training aimed at meeting specific heart rate ranges over time (increasing up to 80% of maximum HRR between the midpoint and endpoint (6-12 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Testing and Training</intervention_name>
    <description>Each study group will perform a baseline maximum load exercise test which will inform the individualized exercise prescription for the participant. Based on a progressive methodology, the participant will engage in 12 weeks of exercise of their choice (walking, running, cycling or swimming) with the goal of working towards a maximum heart rate range of 80% between weeks 6 and 12 of the study.</description>
    <arm_group_label>Chronic Pain//PTSD group</arm_group_label>
    <arm_group_label>Trauma-exposed healthy control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only Veteran and civilian participants in whom a physical examination, medical&#xD;
             history, EKG, and baseline laboratory studies including urine toxicology screens&#xD;
             indicate that maximum load exercise testing will be safe will be included in this&#xD;
             study.&#xD;
&#xD;
          -  Participants must be free of medications and other substances, (e.g., illicit drugs&#xD;
             and alcohol) with effects that could hinder data interpretation for 2-6 weeks&#xD;
             depending on the medication and frequency of use (which must be cleared by the PI's&#xD;
             primary mentor).&#xD;
&#xD;
          -  If on pain medications with short half-lives, must be off of them for 5 half-lives&#xD;
             before testing, generally about 24 hours.&#xD;
&#xD;
          -  Any participant with an ICD9 chronic pain diagnosis, with a musculoskeletal etiology,&#xD;
             as confirmed by the study rehab medicine doctor, will be allowed for inclusion in the&#xD;
             study.&#xD;
&#xD;
          -  Also, any participant with a confirmed psychiatric diagnosis of PTSD (PTSD/chronic&#xD;
             pain group)&#xD;
&#xD;
               -  or have trauma exposure without a diagnosis of PTSD&#xD;
&#xD;
               -  other psychiatric conditions&#xD;
&#xD;
               -  or chronic pain (healthy comparison group) will also be included in the study.&#xD;
&#xD;
          -  Individuals in the PTSD groups must meet for current chronic PTSD (&gt;3 months ) as&#xD;
             assessed by the CAPS 1-Month Diagnostic Version.&#xD;
&#xD;
          -  Healthy trauma exposed individuals must have met criteria for an A1 event, but not&#xD;
             necessarily A2.&#xD;
&#xD;
          -  Finally, healthy, trauma-exposed control participants with a maximum of one major&#xD;
             depressive episode in their past will be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Veteran and civilian participants will be excluded from participation in the study if&#xD;
             they have:&#xD;
&#xD;
               -  a life threatening or acute physical illness (e.g., cancer)&#xD;
&#xD;
               -  current schizophreniform illnesses or bipolar disorder&#xD;
&#xD;
               -  or active suicidal or homicidal ideation requiring clinical intervention.&#xD;
&#xD;
          -  Women participants who are pregnant or are intending to become pregnant within the&#xD;
             next six months will be excluded from participation.&#xD;
&#xD;
          -  Individuals with current or past alcohol and/or substance dependence (less than three&#xD;
             months from date of screening assessment) will be excluded.&#xD;
&#xD;
          -  Healthy individuals with current partial PTSD -- or presently healthy individuals with&#xD;
             a past or lifetime diagnosis of PTSD&#xD;
&#xD;
               -  greater than one major depressive episode or diagnosis of another serious&#xD;
                  psychiatric illness in their past, e.g.:&#xD;
&#xD;
                    -  bipolar disorder or a schizophreniform disorder except for Psychosis not&#xD;
                       otherwise specified due to PTSD-related sensory hallucinations.&#xD;
&#xD;
          -  Individuals seeking pain treatment such as surgical interventions or who have a&#xD;
             neuropathic origin to their pain will also be excluded.&#xD;
&#xD;
          -  Participants with chronic pain concerns that cannot tolerate exercising in a reclining&#xD;
             bike and those who have had a clinical history of coronary artery disease or positive&#xD;
             stress test&#xD;
&#xD;
          -  Uncontrolled cardiac arrhythmia&#xD;
&#xD;
          -  Moderate-to-severe aortic stenosis&#xD;
&#xD;
          -  Severe arterial hypertension (systolic &gt;200 mmHg, diastolic&gt;110 mm Hg)&#xD;
&#xD;
          -  More than first degree atrioventricular block also will be excluded from&#xD;
             participation.&#xD;
&#xD;
          -  Finally, participants who screen positive by answering all four items on the TBI&#xD;
             assessment, will be excluded from participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erica R. Scioli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>This is a VA single site study. There are no plans to share the data outside of VA Boston Healthcare System, unless specifically requested by authorized officials of VA, once the study has ended.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <pending_results>
    <submitted>February 24, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03283163
org study id: D0704-W
secondary id: 1k2 RX000704
nct id: NCT03283163
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The wars in Iraq and Afghanistan are creating a new generation of Veterans, including an
      increasing number of women Veterans, who present with comorbid PTSD and chronic pain
      conditions from recent deployment-related physical injuries and exposure to psychological
      trauma. Health behavior change has become increasingly important in treating these conditions
      and proactively preventing long-term negative health sequelae, in order to benefit these
      Veterans directly and reduce the growing challenges to our healthcare system. The proposed
      CDA-2 program of research will use an innovative translational research approach to study
      whether a chronic progressive -based exercise program will reduce chronic pain in patients
      with PTSD and to elucidate and modify potential PTSD-related deficiencies in neurobiological
      and psychological responses to exercise to optimize the physical and psychological benefits
      of exercise for these individuals.
Due to the COVID-19 pandemic, and after consultation with the appropriate research oversight,
      all study procedures are temporarily suspended as of 3/15/20.

      This study will explicitly compare the effects of a 12-week progressive exercise training
      program on 1) the clinical symptoms of chronic pain and PTSD, 2) pain threshold and
      tolerance, and 3) anti-stress, anti-nociceptive neurohormones such as neuropeptide Y (NPY)
      and allopregnanolone/pregnanolone (ALLO) in Veterans with chronic pain/PTSD compared to
      healthy comparison participants. The revised study design includes a baseline cardiopulmonary
      exercise assessment (CPX) that will inform the exercise prescription for a 12-week
      "progressive exercise" training program, comprised of three 30-45 minute exercise sessions
      per week (walking or running, depending on the ability/capacity of the participant). Exercise
      sessions will be initially supervised by an exercise physiologist in the Clinical Studies
      Unit (CSU) at the VA Boston Healthcare System and then each participant will transition into
      the home. Weekly telephone calls by the PI will provide additional motivational support and
      assistance with problem solving. Implementation of the prescribed exercise regimen will also
      be supported by the use of heart rate and actigraph monitors programmed for the participant
      to achieve their prescribed heart rate range (HRR). Finally, an "endpoint" maximum load
      exercise assessment will occur at week 13 in order to track measurable change for both
      psychological and neurobiological factors and to delineate their impact on pain indices and
      PTSD symptomatology. Both maximum load exercise tests will be performed in accordance with
      guidelines published by the American College of Cardiology. Measures of pain, pain tolerance
      (via the cold pressor test) will be implemented 30 minutes before and 30 minutes after
      exercise testing as well as at a midpoint "check-in" at which self-report questionnaires will
      also be repeated. Based on the PI's earlier research, the role of exercise motivation and
      self-efficacy on changes in perceived pain and pain tolerance will be correlated with changes
      in NPY and ALLO levels, pre and post exercise. It is anticipated that differences in
      biological responses to aerobic and anaerobic exercise between healthy participants and those
      with chronic pain/PTSD will predict differences in the psychological and pain-reducing
      benefits of aerobic and anaerobic exercise. Once identified, such factors could be augmented
      by modification of the exercise regimen in order to help enhance the ant-stress hormone
      levels for the pain/PTSD population and experience clinically significant reductions in their
      symptoms. In order to obtain sufficient power as well as accounting for an expected drop-out
      rate of 18-20%, the proposed recruitment is 30 participants per condition (total of 60
      participants). Data from this pilot work will be used to compute effect sizes in support of a
      future clinical trial incorporating individually prescribed exercise regimens and a
      motivationally based exercise behavior change intervention aimed at reducing pain and PTSD
      symptoms in our Veterans. Advanced education and training is sought by this CDA-2 award
      applicant in four broad areas: 1) psychophysiology of chronic pain and PTSD with a sub-focus
      on sex differences, 2) the neurobiology of chronic stress, PTSD, and pain, 3) exercise
      physiology and 4) the neuropsychology and neurobiology of traumatic brain injury (TBI). The
      combination of didactic and experiential training in these areas will serve the PI's
      long-term goal of becoming an independent scientist/practitioner in the VA focused on
      development of improved treatments for health conditions co-morbid with PTSD such as chronic
      pain and mild TBI. In the shorter-term, this CDA-2 will allow the PI to develop a more
      effective, motivationally based, exercise behavior change protocol that fosters long-term
      exercise compliance in patients with chronic pain/PTSD. This intervention will be used as an
      adjunct to cognitive interventions for these disorders to be further developed and studied
      via a larger VA, NIH, or DOD-funded grant for which the PI will apply in years 4-5 of the
      CDA2.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This study includes two groups: Trauma-exposed healthy controls and individuals suffering from both chronic musculoskeletal pain and PTSD. Those who meet diagnostic criteria for Chronic pain and PTSD will be assigned to that group. Those who are trauma exposed and do not meet criteria for Chronic Pain and PTSD will be assigned to the trauma-exposed control group.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The endpoint assessor will have no knowledge of which study group the participant belongs to.
measure: Change from Baseline: Clinician Administered PTSD Scale -5
time frame: Baseline and endpoint (at 13 weeks)
description: To be administered at: Screening Evaluation & Endpoint 13 week exercise test sessions This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS-5 is currently in the process of being validated however its previous version demonstrated excellent sensitivity (.81) and specificity (.95).57
measure: Change from Baseline: West Haven=Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)
time frame: Baseline, Midpoint (at 6 weeks) and Endpoint (at 13 weeks)
description: The WHY-MPI has been demonstrated to be applicable across a variety of clinical pain conditions. Its brevity, validity/ reliability, self-report nature and ease of scoring make it ideal for both clinical and research purposes. The WHY-MPI is sensitive to change following rehabilitation. Please note only the interference subscale of the WHY-MPI will be administered in this study.
arm group label: Chronic Pain//PTSD group
arm group type: Experimental
description: This group will receive baseline and endpoint maximum load exercise testing which will inform their individualized exercise prescription (based on a progressive methodology) of aerobic exercise training aimed at meeting specific heart rate ranges over time (increasing up to 80% of maximum HRR between the midpoint and endpoint (6-12 weeks).
arm group label: Trauma-exposed healthy control group
arm group type: Active Comparator
description: This group will receive baseline and endpoint maximum load exercise testing which will inform their individualized exercise prescription (based on a progressive methodology) of aerobic exercise training aimed at meeting specific heart rate ranges over time (increasing up to 80% of maximum HRR between the midpoint and endpoint (6-12 weeks).
intervention type: Behavioral
intervention name: Exercise Testing and Training
description: Each study group will perform a baseline maximum load exercise test which will inform the individualized exercise prescription for the participant. Based on a progressive methodology, the participant will engage in 12 weeks of exercise of their choice (walking, running, cycling or swimming) with the goal of working towards a maximum heart rate range of 80% between weeks 6 and 12 of the study.
arm group label: Chronic Pain//PTSD group
arm group label: Trauma-exposed healthy control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erica R. Scioli, PhD
role: Principal Investigator
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Chronic Pain
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Yes
ipd description: This is a VA single site study. There are no plans to share the data outside of VA Boston Healthcare System, unless specifically requested by authorized officials of VA, once the study has ended.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
submitted: February 24, 2023