<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/NCT02239341</url>
  </required_header>
  <id_info>
    <org_study_id>105699</org_study_id>
    <nct_id>NCT02239341</nct_id>
  </id_info>
  <brief_title>Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.</brief_title>
  <official_title>Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Western Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current standard of care for pregnant women deemed to be high-risk often involves&#xD;
      recommending varying levels of activity-restriction, up to and including hospitalization.&#xD;
      High levels of activity-restriction can lead to physical deconditioning of the mother, which&#xD;
      can be difficult to recover from after birth. The proposed study will investigate whether a&#xD;
      mild muscular conditioning program conducted in bed and given to hospitalized&#xD;
      activity-restricted high-risk pregnant women will improve functional ability, cardiovascular&#xD;
      deconditioning and overall quality of life in the postpartum period compared to a control&#xD;
      group with no in hospital bed-rest exercise program. We hypothesize that women with a&#xD;
      in-hospital muscle conditioning program will be better able to perform functional ability&#xD;
      tasks and activities of daily living than a control group with no exercise program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2014</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score on the Functional Mobility Assessment Tool</measure>
    <time_frame>2 weeks post delivery</time_frame>
    <description>The Functional Mobility Assessment Tool was adapted from a senior fitness test, which uses 7 tests to assess muscular strength, aerobic endurance, flexibility and agility (Chair Stand Test, Arm Curl Test, 6-Minute Walk Test, 2-Minute Step Test, Chair Sit-And-Reach Test, Back Scratch Test, and 8-Foot-Up-And-Go Test).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline (&gt; 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery</time_frame>
    <description>The secondary outcome of the study is to examine quality of life in the postpartum period. Quality of life will be measured by completing four surveys the EQ-5D, and the Postpartum Psychological Profile Questionnaire which includes the Depression Scale (1 page), the State Anxiety Index (1 page) and the Postpartum Physical and Psychological Symptoms Report .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow up to Primary outcome Score for Functional Mobility Assessment Tool</measure>
    <time_frame>2, 6 and 12 months</time_frame>
    <description>Changes over time within groups and between groups in the post partum period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>High-Risk Pregnancy</condition>
  <arm_group>
    <arm_group_label>Music Intervention (M)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The M intervention will be 30 minutes (same amount of time as E group), but the participants will simply be listening to the same music in bed with no exercise component. They will be wearing the heart rate monitor as in the E group. The M group will act as a control group for the E group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muscle Conditioning Intervention (E)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E (exercise) is 30 minutes in length and will consist of 5 minutes of warm-up, 20 minutes of light strengthening exercises using a theraband, and 5 minutes of cool-down. All exercises will be completed in bed. Each participant will be listening to the same music (as the M group) during exercise. A heart rate monitor will be worn throughout each session. The first session for each participant will be used to complete baseline measurements and to assess initial muscle strength. Difficulty level will be adjusted by using different strength therabands.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Intervention</intervention_name>
    <description>Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed.</description>
    <arm_group_label>Muscle Conditioning Intervention (E)</arm_group_label>
    <arm_group_label>Music Intervention (M)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscle Conditioning Intervention</intervention_name>
    <description>Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones and also participate in the muscle conditioning program while in bed.</description>
    <arm_group_label>Muscle Conditioning Intervention (E)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized high-risk pregnant women in hospital for at least 7 days&#xD;
&#xD;
          -  Diagnosed with gestational hypertension&#xD;
&#xD;
          -  Diagnosed with preeclampsia (mild to moderate)&#xD;
&#xD;
          -  Diagnosed with intrauterine growth restriction&#xD;
&#xD;
          -  Single baby&#xD;
&#xD;
          -  Expecting twins&#xD;
&#xD;
          -  Expecting triplets&#xD;
&#xD;
          -  Diagnosed with shortened cervix&#xD;
&#xD;
          -  Diagnosed with threatened pre-term labour (not actively contracting)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with symptomatic placenta previa (bleeding)&#xD;
&#xD;
          -  Diagnosed with severe pre-eclampsia (immediate delivery)&#xD;
&#xD;
          -  Diagnosed with conditions indicating a short term hospital stays of less than 7 days&#xD;
&#xD;
          -  Diagnosed with infections&#xD;
&#xD;
          -  Diagnosed with heart and renal disease&#xD;
&#xD;
          -  Diagnosed with diabetes&#xD;
&#xD;
          -  Diagnosed with metabolic bone disease&#xD;
&#xD;
          -  Diagnosed with hyper-or-hypo-thyroidism&#xD;
&#xD;
          -  Diagnosed with Cushing disease and anemia&#xD;
&#xD;
          -  Women carrying more than 3 babies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle F Mottola, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Western Ontario, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>October 12, 2018</last_update_submitted>
  <last_update_submitted_qc>October 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Western Ontario, Canada</investigator_affiliation>
    <investigator_full_name>Michelle Mottola</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>hospitalized</keyword>
  <keyword>activity restriction</keyword>
  <keyword>bed rest</keyword>
  <keyword>antepartum</keyword>
  <keyword>pregnant</keyword>
  <keyword>high risk</keyword>
  <!-- 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/NCT02239341
org study id: 105699
nct id: NCT02239341
lead sponsor: 
has dmc: No
The current standard of care for pregnant women deemed to be high-risk often involves
      recommending varying levels of activity-restriction, up to and including hospitalization.
      High levels of activity-restriction can lead to physical deconditioning of the mother, which
      can be difficult to recover from after birth. The proposed study will investigate whether a
      mild muscular conditioning program conducted in bed and given to hospitalized
      activity-restricted high-risk pregnant women will improve functional ability, cardiovascular
      deconditioning and overall quality of life in the postpartum period compared to a control
      group with no in hospital bed-rest exercise program. We hypothesize that women with a
      in-hospital muscle conditioning program will be better able to perform functional ability
      tasks and activities of daily living than a control group with no exercise program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Score on the Functional Mobility Assessment Tool
time frame: 2 weeks post delivery
description: The Functional Mobility Assessment Tool was adapted from a senior fitness test, which uses 7 tests to assess muscular strength, aerobic endurance, flexibility and agility (Chair Stand Test, Arm Curl Test, 6-Minute Walk Test, 2-Minute Step Test, Chair Sit-And-Reach Test, Back Scratch Test, and 8-Foot-Up-And-Go Test).
measure: Quality of life
time frame: Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery
description: The secondary outcome of the study is to examine quality of life in the postpartum period. Quality of life will be measured by completing four surveys the EQ-5D, and the Postpartum Psychological Profile Questionnaire which includes the Depression Scale (1 page), the State Anxiety Index (1 page) and the Postpartum Physical and Psychological Symptoms Report .
measure: Follow up to Primary outcome Score for Functional Mobility Assessment Tool
time frame: 2, 6 and 12 months
description: Changes over time within groups and between groups in the post partum period
arm group label: Music Intervention (M)
arm group type: Active Comparator
description: The M intervention will be 30 minutes (same amount of time as E group), but the participants will simply be listening to the same music in bed with no exercise component. They will be wearing the heart rate monitor as in the E group. The M group will act as a control group for the E group.
arm group label: Muscle Conditioning Intervention (E)
arm group type: Experimental
description: E (exercise) is 30 minutes in length and will consist of 5 minutes of warm-up, 20 minutes of light strengthening exercises using a theraband, and 5 minutes of cool-down. All exercises will be completed in bed. Each participant will be listening to the same music (as the M group) during exercise. A heart rate monitor will be worn throughout each session. The first session for each participant will be used to complete baseline measurements and to assess initial muscle strength. Difficulty level will be adjusted by using different strength therabands.
intervention type: Other
intervention name: Music Intervention
description: Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed.
arm group label: Muscle Conditioning Intervention (E)
arm group label: Music Intervention (M)
intervention type: Other
intervention name: Muscle Conditioning Intervention
description: Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones and also participate in the muscle conditioning program while in bed.
arm group label: Muscle Conditioning Intervention (E)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle F Mottola, PhD
role: Principal Investigator
affiliation: University of Western Ontario, Canada
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Western Ontario, Canada
investigator full name: Michelle Mottola
investigator title: Dr.