xml: <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/NCT06039319</url>
    </required_header>
    <id_info>
      <org_study_id>4967</org_study_id>
      <nct_id>NCT06039319</nct_id>
    </id_info>
    <brief_title>Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy</brief_title>
    <official_title>Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Tennessee Graduate School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Tennessee Graduate School of Medicine</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>
        Objectives / Specific Aims&#xD;
  &#xD;
          -  The purpose of this study is to investigate the acute effects of a single bout of&#xD;
             moderate intensity maternal exercise on fetal well-being in a pregnancy affected by&#xD;
             fetal growth restriction. Fetal well-being will be measured by biophysical profile&#xD;
             (BPP), non-stress test (NST) and umbilical artery dopplers.&#xD;
  &#xD;
          -  The hypothesis is that a single bout of maternal exercise will not significantly alter&#xD;
             fetal well-being or fetal status.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background and Significance Regular exercise during pregnancy is beneficial in many ways,&#xD;
        including decreased rates of diabetes or hypertensive disorders and decreased risks of&#xD;
        preterm birth and cesarean deliveries. Many people use exercise to treat anxiety and&#xD;
        depression as well as meet gestational weight gain recommendations. Regular exercise, defined&#xD;
        as 150 minutes of moderate intensity exercise per week, is recommended in uncomplicated&#xD;
        pregnancies. In some summary statements, fetal growth restriction (FGR) is noted as a&#xD;
        relative or absolute contraindication to regular exercise. The American College of Obstetrics&#xD;
        and Gynecology (ACOG), however, does not list FGR as a contraindication to maternal exercise.&#xD;
        Currently, there are few high-quality studies about the effect of a recommended amount of&#xD;
        maternal exercise on acute fetal status in pregnancies affected by FGR. The existing theories&#xD;
        conflict. One theory is that maternal exercise will divert blood flow away from the&#xD;
        uterus/fetus which could be deleterious in an already compromised pregnancy. The other theory&#xD;
        is that exercise increases cardiac output and would therefore increase blood flow to the&#xD;
        fetus. A previous study evaluated growth restricted fetuses after a single 5-minute bout of&#xD;
        maternal exercise. This study population was heterogenous and used non-standardized measures&#xD;
        of fetal assessment, making the results difficult to clinically interpret. In a previous&#xD;
        study of healthy pregnancies, 30 minutes of moderate maternal exercise has been determined to&#xD;
        have no effect on acute fetal status. The current study seeks to understand the acute fetal&#xD;
        response to a single maternal exercise episode in pregnancies affected by FGR.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in umbilical artery dopplers systolic/diastolic ratio from pre to post exercise</measure>
      <time_frame>Pre to immediately post acute exercise</time_frame>
      <description>Change in physiological assessment of umbilical artery dopplers systolic/diastolic ratio measured using ultrasound</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in uterine artery dopplers from pre to post exercise</measure>
      <time_frame>Pre to immediately post acute exercise</time_frame>
      <description>Change in physiological assessment of uterine artery dopplers measured using ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fetal middle cerebral arterial (MCA) dopplers pulsatility index from pre to post exercise</measure>
      <time_frame>Pre to immediately post acute exercise</time_frame>
      <description>Change in physiological assessment of fetal middle cerebral arterial (MCA) dopplers pulsatility index measured using ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biophysical Profile (BPP) pre exercise</measure>
      <time_frame>Pre exercise (within 1 hour of the start of acute exercise bout)</time_frame>
      <description>Physiological assessment of Biophysical Profile (BPP) pre exercise using ultrasound, which assesses and scores fetal wellbeing in the following areas: body movement, muscle tone, breathing movements, and amniotic fluid volume. Each component of the biophysical profile receives a score of 0-2, with a total potential score ranging from 0-8. A score of 0 reflects fetal a fetal emergency and/or ominous fetal status and a score of 8 is regarded as &quot;reassuring&quot; which means normal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to complete Biophysical Profile (BPP) pre exercise</measure>
      <time_frame>Pre exercise (within 1 hour of the start of acute exercise bout)</time_frame>
      <description>Time to complete physiological assessment of Biophysical Profile (BPP) pre exercise.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biophysical Profile (BPP) post exercise</measure>
      <time_frame>Immediately post acute exercise</time_frame>
      <description>Physiological assessment of Biophysical Profile (BPP) post exercise using ultrasound, which assesses and scores fetal wellbeing in the following areas: body movement, muscle tone, breathing movements, and amniotic fluid volume. Each component of the biophysical profile receives a score of 0-2, with a total potential score ranging from 0-8. A score of 0 reflects fetal a fetal emergency and/or ominous fetal status and a score of 8 is regarded as &quot;reassuring&quot; which means normal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to complete Biophysical Profile (BPP) post exercise</measure>
      <time_frame>Immediately post acute exercise</time_frame>
      <description>Time to complete physiological assessment of Biophysical Profile (BPP).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in blood glucose from pre to immediately post acute exercise</measure>
      <time_frame>Pre (within 1 hour of the start of acute exercise bout) to immediately post acute exercise</time_frame>
      <description>Change in physiological assessment of capillary blood glucose measured using glucometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in blood lactate from pre to immediately post acute exercise</measure>
      <time_frame>Pre (within 1 hour of the start of acute exercise bout) to immediately post acute exercise</time_frame>
      <description>Change in physiological assessment of capillary blood lactate using lactate analyzer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in maternal mood</measure>
      <time_frame>Pre (within 1 hour of the start of acute exercise bout) to 20 minutes post exercise</time_frame>
      <description>Change in maternal mood using the Brunel Mood Scale Questionnaire. The Brunel Mood Scale is a 32-item questionnaire of current mood descriptors, assessed via 5-point Likert scale questions (&quot;not at all&quot; 0 to &quot;extremely&quot; 4). Mood descriptors are arranged into 8 different subscales (anger, confusion, depression, fatigue, tension, vigor, happiness, calmness), which have a scoring range from 0-16. Higher scores correspond to greater presence of the subscale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in maternal anxiety</measure>
      <time_frame>Pre (within 1 hour of the start of acute exercise bout) to 20 minutes post exercise</time_frame>
      <description>Change in maternal anxiety using the State Trait Anxiety Inventory (STAI) forms Y1 (20 items) and Y2 (20 items) which assess state and trait anxiety. Each STAI item is given a weighted score of 1 to 4. Scores for both the state anxiety and trait anxiety scales can vary from a minimum of 20 to a maximum of 80, where a higher score reflects higher anxiety.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Fetal Growth Retardation</condition>
    <condition>Fetal Growth Complications</condition>
    <condition>Placental Insufficiency</condition>
    <arm_group>
      <arm_group_label>Appropriate Growth</arm_group_label>
      <description>Pregnant individuals with normal estimated fetal weight</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fetal Growth Restricted</arm_group_label>
      <description>Pregnant individuals with fetal growth restriction</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical activity</intervention_name>
      <description>30 minute bout of moderate intensity physical activity performed on a treadmill</description>
      <arm_group_label>Appropriate Growth</arm_group_label>
      <arm_group_label>Fetal Growth Restricted</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant individuals, between 28 weeks 0 days and 36 weeks 6 days gestational age with AGA&#xD;
          or FGR.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion Criteria - FGR population&#xD;
  &#xD;
                 -  Age 18-45&#xD;
  &#xD;
                 -  Intrauterine pregnancy with diagnosis of fetal growth restriction (FGR) as&#xD;
                    defined by total estimated fetal weight &lt;10%ile for EGA or abdominal&#xD;
                    circumference &lt;10%ile for EGA&#xD;
  &#xD;
                 -  Diagnosis of FGR at any point in gestation (preference given for inclusion of&#xD;
                    those diagnosed with FGR after 32w0d)&#xD;
  &#xD;
                 -  Gestational age between 28w0d and 36w6d at time of intervention (based on sure&#xD;
                    last menstrual period (LMP) confirmed by first or second trimester ultrasound or&#xD;
                    unsure LMP with first trimester ultrasound)&#xD;
  &#xD;
                 -  Compliant with standard prenatal care&#xD;
  &#xD;
          Inclusion Criteria - Average for gestational age (AGA) population&#xD;
  &#xD;
            -  Age 18-45&#xD;
  &#xD;
            -  Intrauterine pregnancy with normal estimated fetal growth (EFW &gt;10%ile and &lt;90%ile)&#xD;
  &#xD;
            -  Gestational age between 28w0d and 36w6d at time of intervention with accurate dating&#xD;
               (based on sure LMP confirmed by ultrasound prior to 22 weeks or unsure LMP with first&#xD;
               trimester ultrasound)&#xD;
  &#xD;
            -  Compliant with standard prenatal care&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion Criteria - FGR population&#xD;
  &#xD;
                 -  Known contraindication to completion of 30 minutes of moderate intensity exercise&#xD;
  &#xD;
                 -  Fetal umbilical artery with elevated S/D ratio or absent or reversed diastolic&#xD;
                    flow&#xD;
  &#xD;
                 -  BMI &gt;40&#xD;
  &#xD;
                 -  Severe maternal anemia (Hb less than 8.0)&#xD;
  &#xD;
                 -  Placenta previa&#xD;
  &#xD;
                 -  2nd or 3rd trimester vaginal bleeding&#xD;
  &#xD;
                 -  Preterm premature rupture of membranes&#xD;
  &#xD;
                 -  Cervical insufficiency&#xD;
  &#xD;
                 -  Multi-fetal gestation&#xD;
  &#xD;
                 -  Oligohydramnios&#xD;
  &#xD;
                 -  Hypertensive disorder requiring antihypertensive medication&#xD;
  &#xD;
                 -  Blood pressure &gt;140/90 on the day of the study visit prior to exercise&#xD;
  &#xD;
                 -  Tobacco use&#xD;
  &#xD;
                 -  Opioid agonist therapy&#xD;
  &#xD;
                 -  Known fetal chromosomal anomaly, structural anomaly or infection&#xD;
  &#xD;
                 -  Inability or unwillingness of subject to give informed consent&#xD;
  &#xD;
                 -  Current psychiatric illness/social situation that would limit compliance with&#xD;
                    study requirements, as determined by the principle investigators&#xD;
  &#xD;
          Exclusion Criteria - AGA population&#xD;
  &#xD;
            -  Known contraindication to completion of 30 minutes of moderate intensity exercise&#xD;
  &#xD;
            -  BMI &gt;40&#xD;
  &#xD;
            -  Severe maternal anemia (Hb less than 8.0)&#xD;
  &#xD;
            -  Placenta previa&#xD;
  &#xD;
            -  2nd or 3rd trimester vaginal bleeding&#xD;
  &#xD;
            -  Preterm premature rupture of membranes&#xD;
  &#xD;
            -  Cervical insufficiency&#xD;
  &#xD;
            -  Multi-fetal gestation&#xD;
  &#xD;
            -  Oligohydramnios&#xD;
  &#xD;
            -  Hypertensive disorder requiring antihypertensive medication&#xD;
  &#xD;
            -  Blood pressure &gt;140/90 on the day of the study visit prior to exercise&#xD;
  &#xD;
            -  Tobacco use&#xD;
  &#xD;
            -  Opioid agonist therapy&#xD;
  &#xD;
            -  Known fetal chromosomal anomaly, structural anomaly or infection&#xD;
  &#xD;
            -  Inability or unwillingness of subject to give informed consent&#xD;
  &#xD;
            -  Current psychiatric illness/social situation that would limit compliance with study&#xD;
               requirements, as determined by the principle investigators&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jill M Maples, PhD</last_name>
      <phone>8653059367</phone>
      <email>jmaples1@utmck.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Tennessee Graduate School of Medicine</name>
        <address>
          <city>Knoxville</city>
          <state>Tennessee</state>
          <zip>37920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jill M Maples, PhD</last_name>
        <phone>865-305-9367</phone>
        <email>jmaples1@utmck.edu</email>
      </contact>
      <investigator>
        <last_name>Alissa M Paudel, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kimberly B Fortner, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nikki B Zite, MD, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jill M Maples, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Fetal Growth Retardation</mesh_term>
      <mesh_term>Placental Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>The datasets generated during and/or analyzed during the current study are not publicly available but are available from the investigators on reasonable request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039319
  org study id: 4967
  nct id: NCT06039319
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objectives / Specific Aims
  
          -  The purpose of this study is to investigate the acute effects of a single bout of
             moderate intensity maternal exercise on fetal well-being in a pregnancy affected by
             fetal growth restriction. Fetal well-being will be measured by biophysical profile
             (BPP), non-stress test (NST) and umbilical artery dopplers.
  
          -  The hypothesis is that a single bout of maternal exercise will not significantly alter
             fetal well-being or fetal status.
  Background and Significance Regular exercise during pregnancy is beneficial in many ways,
        including decreased rates of diabetes or hypertensive disorders and decreased risks of
        preterm birth and cesarean deliveries. Many people use exercise to treat anxiety and
        depression as well as meet gestational weight gain recommendations. Regular exercise, defined
        as 150 minutes of moderate intensity exercise per week, is recommended in uncomplicated
        pregnancies. In some summary statements, fetal growth restriction (FGR) is noted as a
        relative or absolute contraindication to regular exercise. The American College of Obstetrics
        and Gynecology (ACOG), however, does not list FGR as a contraindication to maternal exercise.
        Currently, there are few high-quality studies about the effect of a recommended amount of
        maternal exercise on acute fetal status in pregnancies affected by FGR. The existing theories
        conflict. One theory is that maternal exercise will divert blood flow away from the
        uterus/fetus which could be deleterious in an already compromised pregnancy. The other theory
        is that exercise increases cardiac output and would therefore increase blood flow to the
        fetus. A previous study evaluated growth restricted fetuses after a single 5-minute bout of
        maternal exercise. This study population was heterogenous and used non-standardized measures
        of fetal assessment, making the results difficult to clinically interpret. In a previous
        study of healthy pregnancies, 30 minutes of moderate maternal exercise has been determined to
        have no effect on acute fetal status. The current study seeks to understand the acute fetal
        response to a single maternal exercise episode in pregnancies affected by FGR.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Change in umbilical artery dopplers systolic/diastolic ratio from pre to post exercise
  time frame: Pre to immediately post acute exercise
  description: Change in physiological assessment of umbilical artery dopplers systolic/diastolic ratio measured using ultrasound
  measure: Change in uterine artery dopplers from pre to post exercise
  time frame: Pre to immediately post acute exercise
  description: Change in physiological assessment of uterine artery dopplers measured using ultrasound
  measure: Change in fetal middle cerebral arterial (MCA) dopplers pulsatility index from pre to post exercise
  time frame: Pre to immediately post acute exercise
  description: Change in physiological assessment of fetal middle cerebral arterial (MCA) dopplers pulsatility index measured using ultrasound
  measure: Biophysical Profile (BPP) pre exercise
  time frame: Pre exercise (within 1 hour of the start of acute exercise bout)
  description: Physiological assessment of Biophysical Profile (BPP) pre exercise using ultrasound, which assesses and scores fetal wellbeing in the following areas: body movement, muscle tone, breathing movements, and amniotic fluid volume. Each component of the biophysical profile receives a score of 0-2, with a total potential score ranging from 0-8. A score of 0 reflects fetal a fetal emergency and/or ominous fetal status and a score of 8 is regarded as "reassuring" which means normal.
  measure: Time to complete Biophysical Profile (BPP) pre exercise
  time frame: Pre exercise (within 1 hour of the start of acute exercise bout)
  description: Time to complete physiological assessment of Biophysical Profile (BPP) pre exercise.
  measure: Biophysical Profile (BPP) post exercise
  time frame: Immediately post acute exercise
  description: Physiological assessment of Biophysical Profile (BPP) post exercise using ultrasound, which assesses and scores fetal wellbeing in the following areas: body movement, muscle tone, breathing movements, and amniotic fluid volume. Each component of the biophysical profile receives a score of 0-2, with a total potential score ranging from 0-8. A score of 0 reflects fetal a fetal emergency and/or ominous fetal status and a score of 8 is regarded as "reassuring" which means normal.
  measure: Time to complete Biophysical Profile (BPP) post exercise
  time frame: Immediately post acute exercise
  description: Time to complete physiological assessment of Biophysical Profile (BPP).
  measure: Change in blood glucose from pre to immediately post acute exercise
  time frame: Pre (within 1 hour of the start of acute exercise bout) to immediately post acute exercise
  description: Change in physiological assessment of capillary blood glucose measured using glucometer
  measure: Change in blood lactate from pre to immediately post acute exercise
  time frame: Pre (within 1 hour of the start of acute exercise bout) to immediately post acute exercise
  description: Change in physiological assessment of capillary blood lactate using lactate analyzer
  measure: Change in maternal mood
  time frame: Pre (within 1 hour of the start of acute exercise bout) to 20 minutes post exercise
  description: Change in maternal mood using the Brunel Mood Scale Questionnaire. The Brunel Mood Scale is a 32-item questionnaire of current mood descriptors, assessed via 5-point Likert scale questions ("not at all" 0 to "extremely" 4). Mood descriptors are arranged into 8 different subscales (anger, confusion, depression, fatigue, tension, vigor, happiness, calmness), which have a scoring range from 0-16. Higher scores correspond to greater presence of the subscale.
  measure: Change in maternal anxiety
  time frame: Pre (within 1 hour of the start of acute exercise bout) to 20 minutes post exercise
  description: Change in maternal anxiety using the State Trait Anxiety Inventory (STAI) forms Y1 (20 items) and Y2 (20 items) which assess state and trait anxiety. Each STAI item is given a weighted score of 1 to 4. Scores for both the state anxiety and trait anxiety scales can vary from a minimum of 20 to a maximum of 80, where a higher score reflects higher anxiety.
  arm group label: Appropriate Growth
  description: Pregnant individuals with normal estimated fetal weight
  arm group label: Fetal Growth Restricted
  description: Pregnant individuals with fetal growth restriction
  intervention type: Other
  intervention name: Physical activity
  description: 30 minute bout of moderate intensity physical activity performed on a treadmill
  arm group label: Appropriate Growth
  arm group label: Fetal Growth Restricted
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jill M Maples, PhD
  phone: 8653059367
  email: jmaples1@utmck.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Fetal Growth Retardation
  mesh term: Placental Insufficiency
  sharing ipd: Undecided
  ipd description: The datasets generated during and/or analyzed during the current study are not publicly available but are available from the investigators on reasonable request