<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/NCT03261687</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 198588</org_study_id>
    <nct_id>NCT03261687</nct_id>
  </id_info>
  <brief_title>The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain</brief_title>
  <official_title>The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain : a Randomised Controlled Feasibility Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bradford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St George's University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bradford</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>
      This study aimed to address whether a water exercise programme improves pain and quality of&#xD;
      life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise&#xD;
      programme and the feasibility of undertaking a large-scale research programme.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aimed to address whether a water exercise programme improves pain and quality of&#xD;
      life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise&#xD;
      programme and the feasibility of undertaking a large-scale research programme. Twenty-three&#xD;
      participants with diagnosed PGP, recruited at St George's Hospital London, were randomised&#xD;
      into two groups (water or land exercise). Each group received, four, once-weekly exercise&#xD;
      sessions on land or water. Exercise effects on PGP were measured using a variety of outcome&#xD;
      measures. Outcomes were assessed at baseline and post four weeks exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2016</start_date>
  <completion_date type="Actual">January 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>
    <intervention_model_description>a randomised controlled feasibility study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic Girdle Pain Questionnaire (PGPQ)</measure>
    <time_frame>4 weeks (pre and post intervention)</time_frame>
    <description>A score change of 7 was set as a clinically significant difference</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>4 weeks (pre and post intervention)</time_frame>
    <description>score change of 1.5 was set as clinically significant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Specific Functional Score (PSFS)</measure>
    <time_frame>4 weeks (pre and post intervention)</time_frame>
    <description>score change of 1 was set as clinically significant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Active Straight Leg Raise (ASLR).</measure>
    <time_frame>4 weeks (pre and post intervention)</time_frame>
    <description>score change of 1 was set as clinically significant</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Pelvic Girdle Pain</condition>
  <arm_group>
    <arm_group_label>Water Exercise + advice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each group undertook four, once weekly exercise sessions (including a warm up, cool down, relaxation, pelvic control and stability exercise). Both programmes focused on similar exercise and muscle groups, but due to the aquatic medium programmes were unable to be exactly matched.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Land Exercise + advice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each group undertook four, once weekly exercise sessions (including a warm up, cool down, relaxation, pelvic control and stability exercise). Both programmes focused on similar exercise and muscle groups, but due to the aquatic medium programmes were unable to be exactly matched.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>water based exercise</intervention_name>
    <arm_group_label>Water Exercise + advice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>land based exercise</intervention_name>
    <arm_group_label>Land Exercise + advice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>advice</intervention_name>
    <description>general advice given to all subjects</description>
    <arm_group_label>Land Exercise + advice</arm_group_label>
    <arm_group_label>Water Exercise + advice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants were over eighteen years old, over twelve weeks pregnant and able to speak&#xD;
        English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants were excluded from the study if they had uncontrolled blood pressure, placenta&#xD;
        praevia, pre-eclampsia, obstetric cholestatsis, uncontrolled asthma, unstable respiratory&#xD;
        or cardiac conditions, had open skin wounds or MRSA&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St George's Hospital,</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>pelvic girdle pain</keyword>
  <keyword>hydrotherapy</keyword>
  <keyword>quality of life</keyword>
  <keyword>physical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Girdle Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03261687
org study id: IRAS 198588
nct id: NCT03261687
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to address whether a water exercise programme improves pain and quality of
      life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise
      programme and the feasibility of undertaking a large-scale research programme.
This study aimed to address whether a water exercise programme improves pain and quality of
      life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise
      programme and the feasibility of undertaking a large-scale research programme. Twenty-three
      participants with diagnosed PGP, recruited at St George's Hospital London, were randomised
      into two groups (water or land exercise). Each group received, four, once-weekly exercise
      sessions on land or water. Exercise effects on PGP were measured using a variety of outcome
      measures. Outcomes were assessed at baseline and post four weeks exercise.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: a randomised controlled feasibility study
primary purpose: Treatment
masking: None (Open Label)
measure: Pelvic Girdle Pain Questionnaire (PGPQ)
time frame: 4 weeks (pre and post intervention)
description: A score change of 7 was set as a clinically significant difference
measure: Visual Analogue Scale (VAS)
time frame: 4 weeks (pre and post intervention)
description: score change of 1.5 was set as clinically significant
measure: Patient Specific Functional Score (PSFS)
time frame: 4 weeks (pre and post intervention)
description: score change of 1 was set as clinically significant
measure: Active Straight Leg Raise (ASLR).
time frame: 4 weeks (pre and post intervention)
description: score change of 1 was set as clinically significant
arm group label: Water Exercise + advice
arm group type: Experimental
description: Each group undertook four, once weekly exercise sessions (including a warm up, cool down, relaxation, pelvic control and stability exercise). Both programmes focused on similar exercise and muscle groups, but due to the aquatic medium programmes were unable to be exactly matched.
arm group label: Land Exercise + advice
arm group type: Experimental
description: Each group undertook four, once weekly exercise sessions (including a warm up, cool down, relaxation, pelvic control and stability exercise). Both programmes focused on similar exercise and muscle groups, but due to the aquatic medium programmes were unable to be exactly matched.
intervention type: Other
intervention name: water based exercise
arm group label: Water Exercise + advice
intervention type: Other
intervention name: land based exercise
arm group label: Land Exercise + advice
intervention type: Behavioral
intervention name: advice
description: general advice given to all subjects
arm group label: Land Exercise + advice
arm group label: Water Exercise + advice
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pelvic Girdle Pain
sharing ipd: No