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/NCT06031220</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004052</org_study_id>
      <nct_id>NCT06031220</nct_id>
    </id_info>
    <brief_title>Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy</brief_title>
    <official_title>Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Badr University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Badr University</source>
    <oversight_info>
      <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 is to investigate the response of pulmonary function to deep breathing exercise in&#xD;
        twin pregnancy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Physiological changes during pregnancy impose numerous changes on the respiratory system that&#xD;
        can affect the health of both mother and foetus. Regarding the importance of the normal&#xD;
        breathing in the health of mother and foetus.&#xD;
  &#xD;
        Many investigators have studied pulmonary function tests during normal pregnancy, most of&#xD;
        them found a significant decrease in pulmonary function test parameters during all pregnancy&#xD;
        trimesters. Others showed that the PFTs parameters are normal in the first trimester but&#xD;
        there was significant decrease in them in the second and third trimesters, or in the third&#xD;
        trimester only.&#xD;
  &#xD;
        Study Design: Randomized control trial Sixty pregnant women aged 25 to 35 years old and body&#xD;
        mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two&#xD;
        equal groups; control group and study group A: 30 women with twin pregnancy and group B: 30&#xD;
        women with singleton pregnancy (during the third trimester in both groups (27th weeks&#xD;
        gestation), both groups will make deep breathing exercise inform of diaphragmatic and costal&#xD;
        breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test&#xD;
        will be applied at 27th week gestation and at 36th weeks gestation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Actual">June 5, 2023</completion_date>
    <primary_completion_date type="Actual">May 30, 2023</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>forced vital capacity (FVC)</measure>
      <time_frame>FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)</time_frame>
      <description>inspiratory reserve volume + tidal volume+ expiratory reserve volume</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Forced Expiratory Volume in 1 Sec (FEV1)</measure>
      <time_frame>FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)</time_frame>
      <description>Pulmonary Function Tests: (Forced Expiratory Volume in 1 Sec)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FEV1/FVC</measure>
      <time_frame>FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)</time_frame>
      <description>ratio between Forced Expiratory Volume in 1 Sec (FEV1) and forced vital capacity (FVC)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Pregnancy Related</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 women with twin pregnancy during the third trimester at 27th weeks gestation will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied at 27th week gestation and at 36th weeks gestation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>30 women with twin pregnancy during the third trimester at 27th weeks gestation will not receive any special treatment and will be assessed with pulmonary function test at 27th week gestation and at 36th weeks gestation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>deep breathing exercise inform of diaphragmatic and costal breathing</intervention_name>
      <description>deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks,</description>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All pregnant women will be in 27th week gestation&#xD;
  &#xD;
            -  They will be recruited from Soaad kafafy university hospital&#xD;
  &#xD;
            -  Their age between 25-35 years old&#xD;
  &#xD;
            -  Their BMI ≥30Kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women with any pulmonary disorders before pregnancy&#xD;
  &#xD;
            -  Women suffering from any physical or mental disorders.&#xD;
  &#xD;
            -  Pregnant women with gestational diabetes&#xD;
  &#xD;
            -  Pregnant women with gestational hypertension&#xD;
  &#xD;
            -  Pregnant women with asthma&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Radwa S Mahmoud, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Ass. Prof. Dept of PT for pediatrics, Faculty of PT, Cairo University and BUC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Shimaa HA roshdy, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Lecturer of PT Dept of PT for cardiopulmonary and geriatric, Faculty of PT, MUST</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ayman A Elsallamy, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Lecturer of obstetrics and gynecology, Ob/ GYN dept MUST</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Doaa S Mohamed El-sayed, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mina AG Elias, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Lecturer of PT, Dept. of PT for internal medicine and geriatric, Faculty of PT, BUC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Noha A Fouad, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Soaad kafafy university hospital</name>
        <address>
          <city>Giza</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Badr University</investigator_affiliation>
      <investigator_full_name>Noha Ahmed Fouad Abd-Elrahman</investigator_full_name>
      <investigator_title>lecturer of physical therapy for women health</investigator_title>
    </responsible_party>
    <!-- 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/NCT06031220
  org study id: P.T.REC/012/004052
  nct id: NCT06031220
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  this study is to investigate the response of pulmonary function to deep breathing exercise in
        twin pregnancy
  Physiological changes during pregnancy impose numerous changes on the respiratory system that
        can affect the health of both mother and foetus. Regarding the importance of the normal
        breathing in the health of mother and foetus.
  
        Many investigators have studied pulmonary function tests during normal pregnancy, most of
        them found a significant decrease in pulmonary function test parameters during all pregnancy
        trimesters. Others showed that the PFTs parameters are normal in the first trimester but
        there was significant decrease in them in the second and third trimesters, or in the third
        trimester only.
  
        Study Design: Randomized control trial Sixty pregnant women aged 25 to 35 years old and body
        mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two
        equal groups; control group and study group A: 30 women with twin pregnancy and group B: 30
        women with singleton pregnancy (during the third trimester in both groups (27th weeks
        gestation), both groups will make deep breathing exercise inform of diaphragmatic and costal
        breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test
        will be applied at 27th week gestation and at 36th weeks gestation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: forced vital capacity (FVC)
  time frame: FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
  description: inspiratory reserve volume + tidal volume+ expiratory reserve volume
  measure: Forced Expiratory Volume in 1 Sec (FEV1)
  time frame: FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)
  description: Pulmonary Function Tests: (Forced Expiratory Volume in 1 Sec)
  measure: FEV1/FVC
  time frame: FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
  description: ratio between Forced Expiratory Volume in 1 Sec (FEV1) and forced vital capacity (FVC)
  arm group label: study group
  arm group type: Experimental
  description: 30 women with twin pregnancy during the third trimester at 27th weeks gestation will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied at 27th week gestation and at 36th weeks gestation.
  arm group label: control group
  arm group type: No Intervention
  description: 30 women with twin pregnancy during the third trimester at 27th weeks gestation will not receive any special treatment and will be assessed with pulmonary function test at 27th week gestation and at 36th weeks gestation.
  intervention type: Other
  intervention name: deep breathing exercise inform of diaphragmatic and costal breathing
  description: deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks,
  arm group label: study group
  criteria: 
  gender: Female
  minimum age: 25 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Radwa S Mahmoud, PhD
  role: Study Chair
  affiliation: Ass. Prof. Dept of PT for pediatrics, Faculty of PT, Cairo University and BUC
  last name: Shimaa HA roshdy, PhD
  role: Study Chair
  affiliation: Lecturer of PT Dept of PT for cardiopulmonary and geriatric, Faculty of PT, MUST
  last name: Ayman A Elsallamy, PhD
  role: Study Chair
  affiliation: Lecturer of obstetrics and gynecology, Ob/ GYN dept MUST
  last name: Doaa S Mohamed El-sayed, PhD
  role: Study Chair
  affiliation: Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC
  last name: Mina AG Elias, PhD
  role: Study Chair
  affiliation: Lecturer of PT, Dept. of PT for internal medicine and geriatric, Faculty of PT, BUC
  last name: Noha A Fouad, PhD
  role: Principal Investigator
  affiliation: Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Badr University
  investigator full name: Noha Ahmed Fouad Abd-Elrahman
  investigator title: lecturer of physical therapy for women health