An interventional study of core canister training and traditional antenatal exercises in Antenatal Care Model and Gestatiaonl Diabetes Mellitus, sponsored by University of Lahore. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Lahore · Not applicable, Interventional, and Prevention
This randomized control trial aims to determine the effects of structured Core Canister Training on muscular thickness, lumbopelvic stability and pelvic floor function in pregnant women diagnosed with GDM
Gestational Diabetes Mellitus (GDM) affects 7-14% of pregnancies worldwide and is associated not only with metabolic dysregulation but also impaired neuromuscular coordination and pelvic floor dysfunction. The core canister, consisting of the diaphragm, transversus abdominis, lumbar multifidus, and pelvic floor muscles, plays a vital role in lumbopelvic stability and continence. Dysfunction of this system may contribute to low back pain, pelvic girdle pain, and urinary incontinence during pregnancy. This randomized control trial aims to determine the effects of structured Core Canister Training on muscular thickness, lumbopelvic stability and pelvic floor function in pregnant women diagnosed with GDM. It will be conducted in central park trust \& teaching hospital \& Riphah medical center Lahore.90 eligible Participants will be randomized to supervised core canister exercises and standard antenatal exercises, 45 participants in each group three times per week from 20-24 weeks of gestation up to 12 weeks exercise protocol. Primary outcomes include muscular thickness, lumbopelvic stability and pelvic floor muscle performance while secondary outcomes include metabolic outcomes. The tools will be Musculoskeletal Ultrasound Imaging, modified oxford classification, Active Straight Leg Raise Test, Y-Balance test, ICIQ-UI SF,KHQ,6 MWT,GAD-7, pad test. The Data will be analyzed using SPSS version 26.0.
857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's planned enrollment of 90 is below the median of 110 across 560 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Lahore is the lead sponsor of 230 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Core Canister Training targets diaphragm, transversus abdominus, multifidus, pelvic floor exercises
Other: core canister training
The activation of TrA muscle was performed in different positions and progressed from static to dynamic conditions along with baseline treatment(aerobic and resistive ex)
Other: traditional antenatal exercises
•Baseline Treatment: (aerobic + resistive ex) 10min resistive,10 min relaxation ex Diaphragmatic breathing ex:5min rest-5min ex-5min rest/daily • Core \& TrA, pelvic floor\& multifidus: 10 sets of 10 seconds each, 3 sessions per week for 40min Total 12 weeks
•Baseline Treatment: (aerobic + resistive ex) 10min resistive,10 min relaxation ex transversus abdominus focused exercises: 3 sessions per week ,25min per session Total 12 weeks
Musculoskeletal Ultrasound Imaging
is a non-invasive, real-time imaging technique used to quantify muscle thickness and activation widely used in clinical and research settings. Studies consistently show excellent within-examiner reliability (ICC ≥ 0.90) for core muscle thickness measurements across different muscles
Time frame: 12th week
Modified oxford scale
A 6-point digital vaginal palpation scale (0-5) used to grade voluntary pelvic floor muscle strength in women. Correlation coefficients reported between r = 0.60-0.80, Indicates moderate to strong correlation with instrumented measures and intra-rater Reliability is generally good to excellent (ICC range: \~0.80-0.95).
Time frame: 12th week
Active Straight Leg Raise (ASLR) Test
The Active Straight Leg Raise (ASLR) Test is a functional clinical test used to assess ability to generate and transfer load/motor control across the lumbopelvic region, particularly in patients with pelvic girdle pain and suspected instability. Test-Retest Reliability is good to excellent (ICC ≈ 0.83 and Pearson's r ≈ 0.87)
Time frame: 12th week
Y-Balance Test (YBT)
The Y-Balance Test (YBT) is a clinical dynamic balance and functional stability test derived from the Star Excursion Balance Test that assesses a person's ability to maintain balance and control while reaching in three directions (anterior, posteromedial, posterolateral) on a single stance leg - reflecting aspects of lumbopelvic motor control and dynamic stability. Excellent inter-rater reliability has been reported: ICC ≈ 0.99-1.00 for reach distances and composite scores in young adults with chronic low back pain
Time frame: 12th week
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
A short, self-reported questionnaire (3 scored items + 1 unscored) that assesses frequency, severity, and impact of urinary incontinence on quality of life. Widely used in clinical and research settings, including pregnancy and postpartum women. Reliability: Excellent test-retest reliability with ICC = 0.95. Validity: Strong construct validity, correlating well with bladder diaries and pad tests (r = 0.72-0.89). Good internal consistency: Cronbach's α = 0.91
Time frame: 12th week
King's Health Questionnaire (KHQ)
A condition-specific, self-administered quality-of-life questionnaire for urinary incontinence (UI). It consists of 21 items in 9 domains (e.g., general health, incontinence impact, role/emotional/physical/social limitations, sleep/energy, severity measures, and personal relationships). Reliability: High internal consistency: Cronbach's α = 0.72-0.97 across domains. Excellent test-retest reliability: ICC = 0.79-0.93. Validity: (correlation coefficients r = 0.60-0.80).
Time frame: 12th week
Plan to share: No
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