<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/NCT02196571</url>
  </required_header>
  <id_info>
    <org_study_id>Impuls001</org_study_id>
    <nct_id>NCT02196571</nct_id>
  </id_info>
  <brief_title>Structured Aerobic and Resistance Exercise and Gestational Diabetes</brief_title>
  <official_title>The Impact of Structured Aerobic and Resistance Exercise on the Course and Outcome of Gestational Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance of various&#xD;
      degrees first manifested during pregnancy. The primary aim of treating GDM is to optimize&#xD;
      glycaemic control and improve pregnancy outcomes. Also, as part of treatment, it is&#xD;
      recommended to continue or initiate exercising with moderate intensity. However, available&#xD;
      data on the effects of physical activity on GDM are based on a small number of trials. The&#xD;
      aim of the trial is to examine and add new scientific evidence on possible health-related&#xD;
      effects of application of structured programme consisting of aerobic and resistance exercises&#xD;
      on the course and outcomes of GDM. Primary goal of research is to determine how proposed&#xD;
      exercise programme effects glycaemic control, rate of complications during pregnancy, labour,&#xD;
      delivery, immediate after delivery and health status of newborn. Main hypothesis is that&#xD;
      parameters of glycaemic control, course of GDM, complications during delivery and birth&#xD;
      outcomes directly and significantly correlate with participation in structured programme of&#xD;
      exercise. Research will be conducted as experimentally designed randomized controlled trial.&#xD;
      Participants will be pregnant women diagnosed with GDM, age between 20 and 40, without&#xD;
      comorbidities. Women in the experimental group will be included in exercise programme two&#xD;
      times per week with duration of 50 minutes. Training sessions will start right after the&#xD;
      diagnosis and will be performed until the end of the pregnancy. The training protocol will&#xD;
      follow international guidelines (ACOG, 2001; ACOG, 2002; ADA, 2008; NICE, 2008; ADA 2011).&#xD;
      Women in the control group will receive standard medical care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">March 2015</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of pregnant women with complications during pregnancy, labour and delivery</measure>
    <time_frame>up to labour</time_frame>
    <description>Blood glucose levels, need for insulin and oral hypoglycemic drugs, need for cesarean section and other operative delivery methods, other adverse occurences during pregnancy, labour and delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of macrosomic infants</measure>
    <time_frame>delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight gain in pregnancy</measure>
    <time_frame>After recruitment and during pregnancy (30, 33 and 36 weeks)</time_frame>
    <description>Body mass and percentage of fat measured by caliper</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Low Back Pain</measure>
    <time_frame>after recruitment and during pregnancy (30 and 36 weeks)</time_frame>
    <description>Visual analogue scale Roland-Morris Low Back Pain and Disability Questionnaire Pelvic Girdle Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical Activity in Pregnancy</measure>
    <time_frame>After recruitment and in 30th and 36th week of pregnancy</time_frame>
    <description>Pregnancy Physical Activity Questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Exercise and lifestyle change</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the experimental group will be included in structured exercise programme two times per week with duration of 50 minutes.Participants will start with training sessions right after they are diagnosed with GDM and they will exercise until the end of the pregnancy or occurence of contraindications. Programme will consist of aerobic exercises (20 minutes), resistance exercises (20 minutes), plevic floor, stretching and relaxation exercises (10 minutes). Women in control group will receive standard antenatal care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard antenatal care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Structured Exercise</intervention_name>
    <arm_group_label>Exercise and lifestyle change</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  established diagnosis of gestational diabetes,&#xD;
&#xD;
          -  age between 20 and 40,&#xD;
&#xD;
          -  otherwise healthy pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pharmacological treatment with oral hypoglicemics and/or insulin therapy introduced&#xD;
             prior to trial enrollment,&#xD;
&#xD;
          -  existing comorbidities and&#xD;
&#xD;
          -  contraindications for exercise&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iva Sklempe Kokic, PT, PgD Kin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Association for functional rehabilitation, recreation and applied kinesiology Impuls</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Association for functional rehabilitation, recreation and applied kinesiology Impuls</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 16, 2016</last_update_submitted>
  <last_update_submitted_qc>July 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse</investigator_affiliation>
    <investigator_full_name>Iva Sklempe Kokic</investigator_full_name>
    <investigator_title>PT, PgD Kin</investigator_title>
  </responsible_party>
  <keyword>GDM</keyword>
  <keyword>Exercise</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- 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/NCT02196571
org study id: Impuls001
nct id: NCT02196571
lead sponsor: 
has dmc: No
Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance of various
      degrees first manifested during pregnancy. The primary aim of treating GDM is to optimize
      glycaemic control and improve pregnancy outcomes. Also, as part of treatment, it is
      recommended to continue or initiate exercising with moderate intensity. However, available
      data on the effects of physical activity on GDM are based on a small number of trials. The
      aim of the trial is to examine and add new scientific evidence on possible health-related
      effects of application of structured programme consisting of aerobic and resistance exercises
      on the course and outcomes of GDM. Primary goal of research is to determine how proposed
      exercise programme effects glycaemic control, rate of complications during pregnancy, labour,
      delivery, immediate after delivery and health status of newborn. Main hypothesis is that
      parameters of glycaemic control, course of GDM, complications during delivery and birth
      outcomes directly and significantly correlate with participation in structured programme of
      exercise. Research will be conducted as experimentally designed randomized controlled trial.
      Participants will be pregnant women diagnosed with GDM, age between 20 and 40, without
      comorbidities. Women in the experimental group will be included in exercise programme two
      times per week with duration of 50 minutes. Training sessions will start right after the
      diagnosis and will be performed until the end of the pregnancy. The training protocol will
      follow international guidelines (ACOG, 2001; ACOG, 2002; ADA, 2008; NICE, 2008; ADA 2011).
      Women in the control group will receive standard medical care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of pregnant women with complications during pregnancy, labour and delivery
time frame: up to labour
description: Blood glucose levels, need for insulin and oral hypoglycemic drugs, need for cesarean section and other operative delivery methods, other adverse occurences during pregnancy, labour and delivery
measure: Number of macrosomic infants
time frame: delivery
measure: Weight gain in pregnancy
time frame: After recruitment and during pregnancy (30, 33 and 36 weeks)
description: Body mass and percentage of fat measured by caliper
measure: Low Back Pain
time frame: after recruitment and during pregnancy (30 and 36 weeks)
description: Visual analogue scale Roland-Morris Low Back Pain and Disability Questionnaire Pelvic Girdle Questionnaire
measure: Physical Activity in Pregnancy
time frame: After recruitment and in 30th and 36th week of pregnancy
description: Pregnancy Physical Activity Questionnaire
arm group label: Exercise and lifestyle change
arm group type: Experimental
description: Women in the experimental group will be included in structured exercise programme two times per week with duration of 50 minutes.Participants will start with training sessions right after they are diagnosed with GDM and they will exercise until the end of the pregnancy or occurence of contraindications. Programme will consist of aerobic exercises (20 minutes), resistance exercises (20 minutes), plevic floor, stretching and relaxation exercises (10 minutes). Women in control group will receive standard antenatal care.
arm group label: Control
arm group type: No Intervention
description: Standard antenatal care
intervention type: Other
intervention name: Structured Exercise
arm group label: Exercise and lifestyle change
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Iva Sklempe Kokic, PT, PgD Kin
role: Principal Investigator
affiliation: Association for functional rehabilitation, recreation and applied kinesiology Impuls
facility: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
investigator full name: Iva Sklempe Kokic
investigator title: PT, PgD Kin
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus