<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20241222064127N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-24</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effects of abdominal hypopressive exercise on pain intensity, functional disability, transversus abdominis muscle thickness and quality of life in Primiparous female with Sacroiliac hypermobility dysfunction</public_title>
      <acronym>AHE</acronym>
      <scientific_title>Effects of abdominal hypopressive exercise on pain intensity, functional disability, transversus abdominis muscle thickness and quality of life in Primiparous female with Sacroiliac hypermobility dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82000</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: single blinded, single setting, Randomization description: The patients having diagnosed Sacroiliac dysfunction will be recruited in the study by purposive sampling, and the patients who fulfill the inclusion and exclusion criteria will be selected, with similar baseline characteristics. The consent will be taken from the subjects to participate in the study. The subjects will be randomly assigned to one of two groups by using a table of random numbers generated the randomization sequence, using a restricted randomization scheme to assure equal numbers in each group. Random allocation to all groups will be ensured, from all study personnel and participants by entry of data into computer randomization program immediately. Group assignments will be sealed in opaque envelopes and opened sequentially by the investigators, Blinding description: It will be a single blinded trial in which the assessor will be kept blind. Assessor will be senior physiotherapist who will take measurements after giving consent to participate in the study. He will be blind, not confirmed about the group of intervention.</study_design>
      <phase>4</phase>
      <hc_freetext>Sacroiliac hypermobility dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In abdominal hypopressive exercise group the participants will receive 3 sessions of exercises per week over the period of two months. Participants will learn the posture and breathing techniques in the first week. AHT involves 3 cycles of normal breathing followed by total air expiration and gradual contraction of the TrA and intercostal muscle with the rise of the hemi diaphragm and apnea. In 8 weeks the participant will learn performing abdominal hypopressive exercise in different postures in progressive manner. Postures will be repeated three times and apnea will be maintained for an average of 30 seconds. Conventional Physiotherapy which included US with a frequency of 1 MHz and intensity of 0.8 Wcm2 for 5 minutes followed by Corrective exercises.WEEKS EXERCISES Week 1: Standing posture and Tailor Sitting postureWeek 2: Semi-Sitting posture and Tailor Sitting posture Week 3: Supine position and Tailor Sitting posture Week 4: Kneeling posture, Quadruped posture and Genupectoral Sitting posture Week 5: Standing posture and Tailor Sitting posture Week 6: Kneeling posture and Quadruped posture Week 7: Semi-Sitting posture and Supine position Week 8: Tailor sitting posture and Genupectoral Sitting posture. Intervention 2: Control group:Conventional Physiotherapy includes Ultra sound with a frequency of 1 MHz and intensity of 0.8 Wcm2 for 5 minutes followed by Corrective exercises. Corrective ExercisesThe following low back corrective exercises will be given:1.  To stretch the tight lower back muscles- Seated Forward Bend- hold for 5 sec and repeat for 3 times, once a day2.  To stretch the tight lower back muscles- Full Squat hold for 5 sec and repeat for 3 times, once a day3.  To strengthen the weak lower abdomen- Draw inholding for 3 seconds, repeat 5 times, once a day4.  To strengthen the weak lower abdomen- Reverse Crunch- holding for 2 sec, repeating 5 times, twice a day.5.  To stretch the tight hip flexors: Standing Hip Flexor Stretch- hold for 10-15 seconds repeat 5 times on both legs, once a day.6.  To strengthen the weak gluteus: Toed in Glutei Squeeze- hold for 3 sec, repeat 10 times, once a day.7.  To strengthen the weak gluteus: Bridge both single and double leg- hold for 3 seconds, repeat 10 times, once a day8.  To stretch the tight quadriceps: Standing Quadriceps Stretch- holdfor 3 seconds,Repeat 5 times on each side, once a day.9.  To strengthen weak hamstrings: Kick Butts -hold for 2 sec, repeat 8 times, once a day, progression 2 times per day.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all collected IPD for all outcome measures

When:
starting in February, 2025 6 months after publication

To whom:
persons in academic institutes and researchers

Conditions:
it could be used on permission from investigator

Where to obtain:
through email to investigator Halimashoukat92@gmail.com

How to obtain:
through email to investigator Halimashoukat92@gmail.com and Call Halima Shoukat 0923244257755

Comments:
Data will be provided on request</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Halima Shoukat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kotwali road, Gurunanakpura,</address>
        <city>faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 9200952</telephone>
        <email>halimashoukat92@gmail.com</email>
        <affiliation>government college university, faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Halima Shoukat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kotwali road, gurunanakpura</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 9200953</telephone>
        <email>Halimashoukat92@gmail.com</email>
        <affiliation>Government College University, Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient with vaginal delivery
Within one year after post-partum
Unilateral sacroiliac dysfunction
Sacroiliac Forward Flexion Test ( = or more than 5mm difference will suggest sacral torsion)
Positive SI joint dysfunction test (= or more than 3 tests +ve)
The SIJ and posterior elements of the pelvic girdle can be examined using the P4 posterior pelvic pain provocation test, Patrick’s FABER (flexion, abduction, external rotation of the hip) test, active straight leg raise, palpation of the long dorsal sacroiliac ligament and Gaenslen’s test
VAS score equal or greater than 4
•	Modified Oswetry disability index score equal or greater than 15</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
History of Cardiopulmonary Disease
History of Spondyloarthropathies
History of Femoral acetabular impingement
History of  Ischeofemoral impingement
History of  Lumar disc herniation
History of  Lumbar facet syndrome
History of traumatic injury to lumbar spine, sacroiliac joint or hip joint
Diagnosed by physician with any disease other than iliosacral dysfunction
Previous surgical history of back</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M53.2X</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spinal instabilities</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In abdominal hypopressive exercise group the participants will receive 3 sessions of exercises per week over the period of two months. Participants will learn the posture and breathing techniques in the first week. AHT involves 3 cycles of normal breathing followed by total air expiration and gradual contraction of the TrA and intercostal muscle with the rise of the hemi diaphragm and apnea. In 8 weeks the participant will learn performing abdominal hypopressive exercise in different postures in progressive manner. Postures will be repeated three times and apnea will be maintained for an average of 30 seconds. Conventional Physiotherapy which included US with a frequency of 1 MHz and intensity of 0.8 Wcm2 for 5 minutes followed by Corrective exercises.WEEKS EXERCISES Week 1: Standing posture and Tailor Sitting postureWeek 2: Semi-Sitting posture and Tailor Sitting posture Week 3: Supine position and Tailor Sitting posture Week 4: Kneeling posture, Quadruped posture and Genupectoral Sitting posture Week 5: Standing posture and Tailor Sitting posture Week 6: Kneeling posture and Quadruped posture Week 7: Semi-Sitting posture and Supine position Week 8: Tailor sitting posture and Genupectoral Sitting posture</i_keyword>
      <i_keyword>Control group:Conventional Physiotherapy includes Ultra sound with a frequency of 1 MHz and intensity of 0.8 Wcm2 for 5 minutes followed by Corrective exercises. Corrective ExercisesThe following low back corrective exercises will be given:1.  To stretch the tight lower back muscles- Seated Forward Bend- hold for 5 sec and repeat for 3 times, once a day2.  To stretch the tight lower back muscles- Full Squat hold for 5 sec and repeat for 3 times, once a day3.  To strengthen the weak lower abdomen- Draw inholding for 3 seconds, repeat 5 times, once a day4.  To strengthen the weak lower abdomen- Reverse Crunch- holding for 2 sec, repeating 5 times, twice a day.5.  To stretch the tight hip flexors: Standing Hip Flexor Stretch- hold for 10-15 seconds repeat 5 times on both legs, once a day.6.  To strengthen the weak gluteus: Toed in Glutei Squeeze- hold for 3 sec, repeat 10 times, once a day.7.  To strengthen the weak gluteus: Bridge both single and double leg- hold for 3 seconds, repeat 10 times, once a day8.  To stretch the tight quadriceps: Standing Quadriceps Stretch- holdfor 3 seconds,Repeat 5 times on each side, once a day.9.  To strengthen weak hamstrings: Kick Butts -hold for 2 sec, repeat 8 times, once a day, progression 2 times per day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: before intervention, 4 and 8 weeks after intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Functional Disability. Timepoint: before intervention, 4 and 8 weeks after intervention. Method of measurement: Modified Oswestry disability index (MODI).</prim_outcome>
      <prim_outcome>Thickness of transverses abdominus muscle. Timepoint: before and after the intervention. Method of measurement: Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: before and after treatment. Method of measurement: SF-12 questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-20</approval_date>
        <contact_name>Research Ethics committee, Faculty of Allied Health Sciences, The University Of Lahore</contact_name>
        <contact_address>1-km defence road, off bhoptian chowk, Lahore Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
