<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/NCT02189356</url>
  </required_header>
  <id_info>
    <org_study_id>1491-348-11/1539-227</org_study_id>
    <secondary_id>GMMA</secondary_id>
    <nct_id>NCT02189356</nct_id>
  </id_info>
  <brief_title>Gulhane Military Medical Academy Ethical Committee Exercise Program for Pregnant Women With Low Back and Pelvic Pain</brief_title>
  <official_title>Evaluation of the Efficacy of an Exercise Program for Pregnant Women With Low Back and Pelvic Pain: A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the effect of exercise programs on pregnant women with&#xD;
      pregnancy-related Low Back and Pelvic Pain (LBPP). Hypotheses of the study were: 1) Exercise&#xD;
      programs relieve the intensity of LBPP in pregnant women and 2) Exercise programs promote&#xD;
      functional capacity for pregnant women with LBPP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design The study was a prospective randomized trial with a control group (standard care&#xD;
      group) and an intervention group, using a repeated measures design. Forty-eight pregnant&#xD;
      participants with pregnancy-related LBPP were included in the control group and 48 pregnant&#xD;
      participants with pregnancy-related LBPP were included in the intervention (exercise) group.&#xD;
&#xD;
      Participants This research was performed between December 2011 and May 2012 at the Department&#xD;
      of Obstetrics and Gynecology, Gulhane Military Medical Education and Research Hospital in&#xD;
      Ankara, Turkey. Approximately 3,000 births occur annually at this clinic. Participants were&#xD;
      pregnant women who presented to the obstetrics department for routine pregnancy examinations,&#xD;
      had pregnancy-related LBPP and fulfilled the eligibility criteria. Eligibility criteria of&#xD;
      the research were determined following a literature review. The eligibility criteria were;&#xD;
&#xD;
        -  Age over 18 years old&#xD;
&#xD;
        -  Ability to read and write in Turkish,&#xD;
&#xD;
        -  Volunteering to participate in the study,&#xD;
&#xD;
        -  Being between 20-35 weeks of gestation,&#xD;
&#xD;
        -  Having no complications for any reason during the study,&#xD;
&#xD;
        -  No diagnosis of low back and/or pelvic disease prior to pregnancy,&#xD;
&#xD;
        -  Not performing exercise for half an hour at least three days a week during pregnancy,&#xD;
&#xD;
        -  Not using analgesics for low back and pelvis pain,&#xD;
&#xD;
        -  Not using other methods for the treatment low back and pelvic pain,&#xD;
&#xD;
        -  Giving birth before the completion of the study Interventions Participants diagnosed&#xD;
           with pregnancy-related LBPP by a doctor and with no medical obstacles to participation&#xD;
           in the study were directed to nurse. The nurse invited the pregnant women to the&#xD;
           research room for a discussion about low back and pelvic pain. After the eligibility&#xD;
           criteria of the pregnant women were reviewed, initial assessments were completed and the&#xD;
           participants were subsequently randomized.&#xD;
&#xD;
      The nurse gave health counseling to the participants in the intervention group about the&#xD;
      prevention of pregnancy-related LBPP and initiated an exercise program that included exercise&#xD;
      training. The health counseling and exercise training booklets provided were prepared based&#xD;
      on the literature. Each counseling session lasted an average of 45 minutes. Sessions were&#xD;
      completed in a positive education atmosphere and were face-to-face as consistent with the&#xD;
      principles of adult education. The structure and function of the vertebrae, physical changes&#xD;
      occurring during pregnancy, causes of pregnancy-related LBPP, the problems that the pain&#xD;
      causes, methods of pain management, correct posture development, body mechanics during&#xD;
      activities of daily life and ergonomics were explained to the pregnant women using&#xD;
      illustrated booklets given during the trainings. During the counseling, the nurse received&#xD;
      information from the participants regarding their daily activities and educated the&#xD;
      participants about the behaviors that might damage the low back and pelvic regions.&#xD;
      Participants were given practical demonstrations of how to move and how to protect the low&#xD;
      back and pelvic regions during daily life. For example, the nurse demonstrated how to&#xD;
      retrieve an object from the ground, how to reach shelves, how to sit and stand up and how to&#xD;
      lie down, guiding the participants through these activities as well. The participants'&#xD;
      questions were answered, and they were given educational booklets. Following the health&#xD;
      consultation, exercise education was given. The participants were given illustrated booklets&#xD;
      explaining the effects of pregnancy exercises on maternal and fetal health, situations that&#xD;
      need attention before starting and during exercises, signs of danger, what should be done in&#xD;
      potentially dangerous situations, how to breathe during exercise and the method, frequency&#xD;
      and amount of the exercise. The exercises given to the intervention group were based on the&#xD;
      guidelines from &quot;Exercise in Pregnancy&quot; by the Royal College of Obstetricians and&#xD;
      Gynaecologists (RCOG) and the guidelines from &quot;Pregnancy and Exercise&quot; by Hacettepe&#xD;
      University in Turkey. It was emphasized that pregnant women should complete their exercises&#xD;
      as shown at least three days a week for 30 minutes. The duration of the exercise program was&#xD;
      four weeks. Participants were offered a choice of two types of exercise according to the&#xD;
      weather conditions. The first option comprised exercises performed on a mattress, including&#xD;
      stretching, tightening and loosening movements that targeted large muscle groups from the&#xD;
      neck to the vertebrae. The nurse explained that the mattress exercises would start with a 5&#xD;
      minute warm up, continue for at least 15-20 minutes at mid-tempo and end with a 5 minute cool&#xD;
      down. The second option was a walking exercise. The participants were expected to warm up for&#xD;
      5 minutes, increase their speed for 5 minutes, continue at mid-tempo for 15 minutes and&#xD;
      complete a 5 minute cool down. It was emphasized that the pulse rate should be between&#xD;
      120-160/min when the participants reached mid-tempo. In this exercise program, we assumed&#xD;
      that both the walking exercise and the mattress exercises had equal effects on the low back&#xD;
      and pelvic pain. Pregnant women were able to choose the type of exercise according to their&#xD;
      wishes and requirements and could use either or both of the exercise options. The nurse&#xD;
      determined the exercise plan with the pregnant women, creating an individual exercise program&#xD;
      according to the patient's personal characteristics. The participants were asked to record&#xD;
      the type and the duration of the completed exercises during the program on the data&#xD;
      collection form and were asked to note if they encountered any problems during the program.&#xD;
      The nurse taught the participants how to fill out the forms and answered any questions about&#xD;
      the programs. The nurse spoke with the pregnant women on the phone three times a week and&#xD;
      gave counseling according to their needs. During interviews, pregnant women were reminded to&#xD;
      complete the data collection forms. After four weeks, the researchers made a final assessment&#xD;
      of the pregnant women and collected the forms during a face-to-face interview. The exercise&#xD;
      programs were terminated at this point, though the pregnant women were able to continue the&#xD;
      counseling if they wished.&#xD;
&#xD;
      The pregnant women in the control group received usual care, comprised of routine clinical&#xD;
      practice for pregnancy-related LBPP. The control group participants were recommended bed rest&#xD;
      and analgesics for LBPP and were not given any treatment for LBPP in addition to standard&#xD;
      care. Pregnant women in the control group did not exercise before the study or during the&#xD;
      study. The nurse spoke with the women in the control group on the phone once a week and asked&#xD;
      them to assess their LBPP and complete the data collection form. The final assessments of the&#xD;
      participants were made during a face-to-face interview four weeks later. Willing pregnant&#xD;
      women in the control group were advised on pain management strategies after completion of the&#xD;
      four weeks of the study.&#xD;
&#xD;
      Sample size and statistical power considerations The sample size was calculated using the PS&#xD;
      Software: Power and Sample Size program. Using the literature, we calculated that a sample&#xD;
      size of 48 pregnant women in both the exercise group and the control group (total 96 pregnant&#xD;
      women) could allow for detection of a difference in VAS score of 10 mm between the&#xD;
      intervention and control group, given a SD of 15 mm with accompanying 0.95% confidence&#xD;
      intervals (CI) and a power of 0.90.&#xD;
&#xD;
      Randomization According to the CONSORT requirements, the participants were randomly allocated&#xD;
      to either the intervention group (n=48) or the control group (n=48) using opaque, sealed&#xD;
      envelopes and a simple randomization method. The nurse at the clinic randomly drew the&#xD;
      envelopes and broke the seal in the nursing room. The nurse explained the study's purpose and&#xD;
      procedures to the pregnant women in the control and intervention groups. The same procedure&#xD;
      was repeated for all the pregnant women. Blinding of participants was not feasible due to the&#xD;
      study design.&#xD;
&#xD;
      Primary outcomes The primary outcomes of this study were the change in pain intensity at the&#xD;
      end of four weeks compared with the baseline and the changes in functional status at the end&#xD;
      of weeks first and fourth.&#xD;
&#xD;
      Data collection The nurse collected the data by meeting with the pregnant women at the&#xD;
      beginning and end of the study for a total of two interviews. The data collection form&#xD;
      included the sociodemographic characteristics of the pregnant women, their pregnancy history,&#xD;
      and questions regarding any history of pain. In these meetings the nurse measured the&#xD;
      severity of the LBPP and determined the functional status of the pregnant women. The&#xD;
      participants measured the severity of LBPP at the end of each week for a total of 4&#xD;
      measurements and recorded their pain on a &quot;Weekly Pain Follow-up Form&quot;. Additionally,&#xD;
      participants in the intervention group recorded their exercises on a &quot;Daily Exercise Form&quot;.&#xD;
      The forms were collected for evaluation by the nurse at the completion of the study.&#xD;
&#xD;
      Measures Pain Intensity We used the Visual Analogue Scale (VAS) to measure the intensity of&#xD;
      the participants' pain. The VAS is a reliable and valid scale that widely used all over the&#xD;
      world for the assessment of pain intensity. Pregnant women noted the severity of the low back&#xD;
      and pelvic pain that they perceived on a 100 mm VAS. The nurse determined the intensity of&#xD;
      pain by measuring the point the pregnant woman had marked with a ruler. We examined the&#xD;
      intensity of two types of pain; perceived pain intensity at rest as VASrelaxation and&#xD;
      perceived pain intensity during activity as VASactivity.&#xD;
&#xD;
      Functional Level The Oswestry Disability Index (ODI) was used to determine the participants'&#xD;
      functional status. The ODI was developed in 1976 by O'Brien and is a condition-specific&#xD;
      outcome measure used in the management of spinal disorders. The ODI has been broadly tested&#xD;
      and was found to have good psychometric properties and to be useful in a wide variety of&#xD;
      settings. The ODI is the 'gold standard' for low back functional outcome instruments, is&#xD;
      self-administered and consists of a 10-item questionnaire. The first section evaluates the&#xD;
      intensity of pain and the others describe its disabling effects on typical daily activities&#xD;
      including personal care activities (washing, dressing), lifting, walking, sitting, standing,&#xD;
      sleeping, social life and travelling. Each item is scored from 0 to 5, with higher values&#xD;
      demonstrating greater disability. The ODI's validity and reliability in the Turkish&#xD;
      population was examined by Yakut et al. (2004) and the Cronbach α value was reported as 0.91.&#xD;
&#xD;
      Exercise Level Exercise diaries are easy, cost-effective and frequently used methods to&#xD;
      measure physical activity. In this study, exercise diaries were used to determine the&#xD;
      exercise levels of participants in the intervention group. Exercise for 30 minutes at least 3&#xD;
      days a week was considered sufficient.&#xD;
&#xD;
      Ethical Considerations An Academy Ethical Committee approved the study design, protocols and&#xD;
      informed consent procedure with number 1491-348-11/1539-227. Participants were informed about&#xD;
      the study before inclusion and could decline to participate at any time. The participants&#xD;
      read and signed the informed consent form with the help of the nurse at the beginning of the&#xD;
      study.&#xD;
&#xD;
      Data Analysis Based on the intention-to-treat principle, all pregnant women were analyzed&#xD;
      according to the group they were assigned to, regardless of whether they received the&#xD;
      intervention or not. Missing data were not imputed. To investigate the differences between&#xD;
      the groups, the Student's t test was used for values with a normal distribution and the&#xD;
      Mann-Whitney U test was used for values without a normal distribution. To investigate the&#xD;
      differences within the groups, the paired samples t test was used for values with a normal&#xD;
      distribution and the Wilcoxon test was used for values without a normal distribution.&#xD;
      Repeated measurement results that did not have a normal distribution were analyzed using the&#xD;
      Friedman Test. The error level for all analysis was set at p = 0.05. The results were&#xD;
      analyzed using SPSS, version 15.0 (SPSS Inc., Chicago, IL, USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain intensity</measure>
    <time_frame>4 weeks</time_frame>
    <description>We used the Visual Analogue Scale (VAS) to measure the intensity of the participants' pain. The VAS is a reliable and valid scale that widely used all over the world for the assessment of pain intensity (Wewers &amp; Lowe 1990, Lindseth &amp; Vari 2005, Kalus et al. 2008, Potter 2013, Murphy et al. 2009).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Oswestry Disability Index</measure>
    <time_frame>4 weeks</time_frame>
    <description>The Oswestry Disability Index (ODI) was used to determine the participants' functional status. The ODI was developed in 1976 by O'Brien (Fairbank &amp; Pynsent 2000) and is a condition-specific outcome measure used in the management of spinal disorders.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Pregnant</condition>
  <condition>Pregnancy-related Low Back and Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>exercise programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Forty-eight pregnant participants with pregnancy-related LBPP were included in the control group and 48 pregnant participants with pregnancy-related LBPP were included in the intervention (exercise) group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>contol group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Forty-eight pregnant participants with pregnancy-related LBPP were included in the control group and 48 pregnant participants with pregnancy-related LBPP were included in the intervention (exercise) group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>exercise programme</intervention_name>
    <description>The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Forty-eight pregnant participants with pregnancy-related LBPP were included in the control group and 48 pregnant participants with pregnancy-related LBPP were included in the intervention (exercise) group</description>
    <arm_group_label>exercise programme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>standard care</intervention_name>
    <description>standard pregnancy follow up</description>
    <arm_group_label>contol group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Age over 18 years old&#xD;
&#xD;
          -  Ability to read and write in Turkish,&#xD;
&#xD;
          -  Volunteering to participate in the study,&#xD;
&#xD;
          -  Being between 20-35 weeks of gestation,&#xD;
&#xD;
          -  Having no complications for any reason during the study,&#xD;
&#xD;
          -  No diagnosis of low back and/or pelvic disease prior to pregnancy,&#xD;
&#xD;
          -  Not performing exercise for half an hour at least three days a week during pregnancy,&#xD;
&#xD;
          -  Not using analgesics for low back and pelvis pain,&#xD;
&#xD;
          -  Not using other methods for the treatment low back and pelvic pain,&#xD;
&#xD;
          -  Giving birth before the completion of the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 12, 2014</last_update_submitted>
  <last_update_submitted_qc>July 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</investigator_affiliation>
    <investigator_full_name>Serpil Ozdemir, PhD, RN</investigator_full_name>
    <investigator_title>PhD, RN</investigator_title>
  </responsible_party>
  <keyword>Pregnancy-related low back and pelvic pain</keyword>
  <keyword>exercise program</keyword>
  <keyword>nurse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Pain</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/NCT02189356
org study id: 1491-348-11/1539-227
secondary id: GMMA
nct id: NCT02189356
lead sponsor: 
has dmc: No
The aim of this study was to evaluate the effect of exercise programs on pregnant women with
      pregnancy-related Low Back and Pelvic Pain (LBPP). Hypotheses of the study were: 1) Exercise
      programs relieve the intensity of LBPP in pregnant women and 2) Exercise programs promote
      functional capacity for pregnant women with LBPP.
Design The study was a prospective randomized trial with a control group (standard care
      group) and an intervention group, using a repeated measures design. Forty-eight pregnant
      participants with pregnancy-related LBPP were included in the control group and 48 pregnant
      participants with pregnancy-related LBPP were included in the intervention (exercise) group.

      Participants This research was performed between December 2011 and May 2012 at the Department
      of Obstetrics and Gynecology, Gulhane Military Medical Education and Research Hospital in
      Ankara, Turkey. Approximately 3,000 births occur annually at this clinic. Participants were
      pregnant women who presented to the obstetrics department for routine pregnancy examinations,
      had pregnancy-related LBPP and fulfilled the eligibility criteria. Eligibility criteria of
      the research were determined following a literature review. The eligibility criteria were;

        -  Age over 18 years old

        -  Ability to read and write in Turkish,

        -  Volunteering to participate in the study,

        -  Being between 20-35 weeks of gestation,

        -  Having no complications for any reason during the study,

        -  No diagnosis of low back and/or pelvic disease prior to pregnancy,

        -  Not performing exercise for half an hour at least three days a week during pregnancy,

        -  Not using analgesics for low back and pelvis pain,

        -  Not using other methods for the treatment low back and pelvic pain,

        -  Giving birth before the completion of the study Interventions Participants diagnosed
           with pregnancy-related LBPP by a doctor and with no medical obstacles to participation
           in the study were directed to nurse. The nurse invited the pregnant women to the
           research room for a discussion about low back and pelvic pain. After the eligibility
           criteria of the pregnant women were reviewed, initial assessments were completed and the
           participants were subsequently randomized.

      The nurse gave health counseling to the participants in the intervention group about the
      prevention of pregnancy-related LBPP and initiated an exercise program that included exercise
      training. The health counseling and exercise training booklets provided were prepared based
      on the literature. Each counseling session lasted an average of 45 minutes. Sessions were
      completed in a positive education atmosphere and were face-to-face as consistent with the
      principles of adult education. The structure and function of the vertebrae, physical changes
      occurring during pregnancy, causes of pregnancy-related LBPP, the problems that the pain
      causes, methods of pain management, correct posture development, body mechanics during
      activities of daily life and ergonomics were explained to the pregnant women using
      illustrated booklets given during the trainings. During the counseling, the nurse received
      information from the participants regarding their daily activities and educated the
      participants about the behaviors that might damage the low back and pelvic regions.
      Participants were given practical demonstrations of how to move and how to protect the low
      back and pelvic regions during daily life. For example, the nurse demonstrated how to
      retrieve an object from the ground, how to reach shelves, how to sit and stand up and how to
      lie down, guiding the participants through these activities as well. The participants'
      questions were answered, and they were given educational booklets. Following the health
      consultation, exercise education was given. The participants were given illustrated booklets
      explaining the effects of pregnancy exercises on maternal and fetal health, situations that
      need attention before starting and during exercises, signs of danger, what should be done in
      potentially dangerous situations, how to breathe during exercise and the method, frequency
      and amount of the exercise. The exercises given to the intervention group were based on the
      guidelines from "Exercise in Pregnancy" by the Royal College of Obstetricians and
      Gynaecologists (RCOG) and the guidelines from "Pregnancy and Exercise" by Hacettepe
      University in Turkey. It was emphasized that pregnant women should complete their exercises
      as shown at least three days a week for 30 minutes. The duration of the exercise program was
      four weeks. Participants were offered a choice of two types of exercise according to the
      weather conditions. The first option comprised exercises performed on a mattress, including
      stretching, tightening and loosening movements that targeted large muscle groups from the
      neck to the vertebrae. The nurse explained that the mattress exercises would start with a 5
      minute warm up, continue for at least 15-20 minutes at mid-tempo and end with a 5 minute cool
      down. The second option was a walking exercise. The participants were expected to warm up for
      5 minutes, increase their speed for 5 minutes, continue at mid-tempo for 15 minutes and
      complete a 5 minute cool down. It was emphasized that the pulse rate should be between
      120-160/min when the participants reached mid-tempo. In this exercise program, we assumed
      that both the walking exercise and the mattress exercises had equal effects on the low back
      and pelvic pain. Pregnant women were able to choose the type of exercise according to their
      wishes and requirements and could use either or both of the exercise options. The nurse
      determined the exercise plan with the pregnant women, creating an individual exercise program
      according to the patient's personal characteristics. The participants were asked to record
      the type and the duration of the completed exercises during the program on the data
      collection form and were asked to note if they encountered any problems during the program.
      The nurse taught the participants how to fill out the forms and answered any questions about
      the programs. The nurse spoke with the pregnant women on the phone three times a week and
      gave counseling according to their needs. During interviews, pregnant women were reminded to
      complete the data collection forms. After four weeks, the researchers made a final assessment
      of the pregnant women and collected the forms during a face-to-face interview. The exercise
      programs were terminated at this point, though the pregnant women were able to continue the
      counseling if they wished.

      The pregnant women in the control group received usual care, comprised of routine clinical
      practice for pregnancy-related LBPP. The control group participants were recommended bed rest
      and analgesics for LBPP and were not given any treatment for LBPP in addition to standard
      care. Pregnant women in the control group did not exercise before the study or during the
      study. The nurse spoke with the women in the control group on the phone once a week and asked
      them to assess their LBPP and complete the data collection form. The final assessments of the
      participants were made during a face-to-face interview four weeks later. Willing pregnant
      women in the control group were advised on pain management strategies after completion of the
      four weeks of the study.

      Sample size and statistical power considerations The sample size was calculated using the PS
      Software: Power and Sample Size program. Using the literature, we calculated that a sample
      size of 48 pregnant women in both the exercise group and the control group (total 96 pregnant
      women) could allow for detection of a difference in VAS score of 10 mm between the
      intervention and control group, given a SD of 15 mm with accompanying 0.95% confidence
      intervals (CI) and a power of 0.90.

      Randomization According to the CONSORT requirements, the participants were randomly allocated
      to either the intervention group (n=48) or the control group (n=48) using opaque, sealed
      envelopes and a simple randomization method. The nurse at the clinic randomly drew the
      envelopes and broke the seal in the nursing room. The nurse explained the study's purpose and
      procedures to the pregnant women in the control and intervention groups. The same procedure
      was repeated for all the pregnant women. Blinding of participants was not feasible due to the
      study design.

      Primary outcomes The primary outcomes of this study were the change in pain intensity at the
      end of four weeks compared with the baseline and the changes in functional status at the end
      of weeks first and fourth.

      Data collection The nurse collected the data by meeting with the pregnant women at the
      beginning and end of the study for a total of two interviews. The data collection form
      included the sociodemographic characteristics of the pregnant women, their pregnancy history,
      and questions regarding any history of pain. In these meetings the nurse measured the
      severity of the LBPP and determined the functional status of the pregnant women. The
      participants measured the severity of LBPP at the end of each week for a total of 4
      measurements and recorded their pain on a "Weekly Pain Follow-up Form". Additionally,
      participants in the intervention group recorded their exercises on a "Daily Exercise Form".
      The forms were collected for evaluation by the nurse at the completion of the study.

      Measures Pain Intensity We used the Visual Analogue Scale (VAS) to measure the intensity of
      the participants' pain. The VAS is a reliable and valid scale that widely used all over the
      world for the assessment of pain intensity. Pregnant women noted the severity of the low back
      and pelvic pain that they perceived on a 100 mm VAS. The nurse determined the intensity of
      pain by measuring the point the pregnant woman had marked with a ruler. We examined the
      intensity of two types of pain; perceived pain intensity at rest as VASrelaxation and
      perceived pain intensity during activity as VASactivity.

      Functional Level The Oswestry Disability Index (ODI) was used to determine the participants'
      functional status. The ODI was developed in 1976 by O'Brien and is a condition-specific
      outcome measure used in the management of spinal disorders. The ODI has been broadly tested
      and was found to have good psychometric properties and to be useful in a wide variety of
      settings. The ODI is the 'gold standard' for low back functional outcome instruments, is
      self-administered and consists of a 10-item questionnaire. The first section evaluates the
      intensity of pain and the others describe its disabling effects on typical daily activities
      including personal care activities (washing, dressing), lifting, walking, sitting, standing,
      sleeping, social life and travelling. Each item is scored from 0 to 5, with higher values
      demonstrating greater disability. The ODI's validity and reliability in the Turkish
      population was examined by Yakut et al. (2004) and the Cronbach α value was reported as 0.91.

      Exercise Level Exercise diaries are easy, cost-effective and frequently used methods to
      measure physical activity. In this study, exercise diaries were used to determine the
      exercise levels of participants in the intervention group. Exercise for 30 minutes at least 3
      days a week was considered sufficient.

      Ethical Considerations An Academy Ethical Committee approved the study design, protocols and
      informed consent procedure with number 1491-348-11/1539-227. Participants were informed about
      the study before inclusion and could decline to participate at any time. The participants
      read and signed the informed consent form with the help of the nurse at the beginning of the
      study.

      Data Analysis Based on the intention-to-treat principle, all pregnant women were analyzed
      according to the group they were assigned to, regardless of whether they received the
      intervention or not. Missing data were not imputed. To investigate the differences between
      the groups, the Student's t test was used for values with a normal distribution and the
      Mann-Whitney U test was used for values without a normal distribution. To investigate the
      differences within the groups, the paired samples t test was used for values with a normal
      distribution and the Wilcoxon test was used for values without a normal distribution.
      Repeated measurement results that did not have a normal distribution were analyzed using the
      Friedman Test. The error level for all analysis was set at p = 0.05. The results were
      analyzed using SPSS, version 15.0 (SPSS Inc., Chicago, IL, USA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: pain intensity
time frame: 4 weeks
description: We used the Visual Analogue Scale (VAS) to measure the intensity of the participants' pain. The VAS is a reliable and valid scale that widely used all over the world for the assessment of pain intensity (Wewers & Lowe 1990, Lindseth & Vari 2005, Kalus et al. 2008, Potter 2013, Murphy et al. 2009).
measure: The Oswestry Disability Index
time frame: 4 weeks
description: The Oswestry Disability Index (ODI) was used to determine the participants' functional status. The ODI was developed in 1976 by O'Brien (Fairbank & Pynsent 2000) and is a condition-specific outcome measure used in the management of spinal disorders.
arm group label: exercise programme
arm group type: Experimental
description: The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Forty-eight pregnant participants with pregnancy-related LBPP were included in the control group and 48 pregnant participants with pregnancy-related LBPP were included in the intervention (exercise) group.
arm group label: contol group
arm group type: Other
description: The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Forty-eight pregnant participants with pregnancy-related LBPP were included in the control group and 48 pregnant participants with pregnancy-related LBPP were included in the intervention (exercise) group.
intervention type: Behavioral
intervention name: exercise programme
description: The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Forty-eight pregnant participants with pregnancy-related LBPP were included in the control group and 48 pregnant participants with pregnancy-related LBPP were included in the intervention (exercise) group
arm group label: exercise programme
intervention type: Behavioral
intervention name: standard care
description: standard pregnancy follow up
arm group label: contol group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
investigator full name: Serpil Ozdemir, PhD, RN
investigator title: PhD, RN
mesh term: Pelvic Pain