Antenatal Care ModelNCT07889791
Effects Of Core Canister Training in Pregnant Women With History of Gestational Diabetes Mellitus
A study testing core canister training and traditional antenatal exercises in people with Antenatal Care Model and Gestatiaonl Diabetes Mellitus, run by University of Lahore at 1 site in Pakistan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Care Model, Gestatiaonl Diabetes Mellitus
- What is being tested?
- core canister training and traditional antenatal exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jul 2026to 1 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently in their second pregnancy
- Documented history of GDM in the first pregnancy
- Gestational age 20-24 weeks at the time of enrollment. The upper limit of gestational age will set at 24 weeks at the time of inclusion to allow for at least 12 weeks of intervention.
- Singleton pregnancy
- Body mass index (BMI) <40 kg/m2)
- Muscle strength of upper \& lower limb at level IV or above
- Suffering from stress urinary incontinence diagnosed by Cough Stress Test.
- Medically cleared for physical activity by their obstetrician
Who cannot join
- Pre-existing type 1 or type 2 diabetes mellitus
- Previous history of abortion
- Patients with severe obstetric complications and contraindications listed in the 2023 of BMJ entitled Public health guidelines for physical activity during pregnancy
- High-risk obstetric complications (e.g., preeclampsia, placenta previa)
- Musculoskeletal or neurological disorders limiting physical activity
- Any current or previous pelvic floor dysfunction diagnosed by healthcare professionals like pelvic organ prolapse grade III or IV
Show all 9Show fewer
- Participation in any other structured exercise or lifestyle intervention program
- Severe damage to the heart, liver, lungs, or kidneys
- Acute or chronic complications caused by diabetes, such as ketoacidosis or diabetic foot
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Central Park trust & teaching hospital, Riphah medical center
Lahore, Punjab Province, 6400
Maryam Professor, HoD, University Institute of Physical Therapy, PhD, 03004391550, maryam.shabbir@uipt.uol.edu.pk
Hina gul, PhD*
About this study
Official title: Effects of Core Canister Training on Muscular Thickness, Lumbopelvic Stability and Pelvic Floor Function in Pregnant Women With History of Gestational Diabetes Mellitus
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
Read the detailed description
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.
- Being tested
- core canister training, traditional antenatal exercises
- Keywords
- aerobic exercise, pregnant women, gestational diabetes mellitus, rehabilitation exercises, pelvic floor, resistance training
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core canister trainingOther
•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
traditional antenatal exercisesOther
•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
| Study group | Role | What they receive |
|---|---|---|
| Core Canister Training | Experimental | Core Canister Training targets diaphragm, transversus abdominus, multifidus, pelvic floor exercises Receives: Other: core canister training |
| traditional antenatal exercises | Active comparator | 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) Receives: Other: traditional antenatal exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start20 Jul 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Antenatal Care ModelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- systematic review tool translation core canister training
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shabbir, PhD, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889791
- Sponsor's protocol ID
- UOL/IREB/26/22/01/0001
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prudencio CB, Nunes SK, Pinheiro FA, Sartorao Filho CI, Nava GTA, Salomoni SE, Pedroni CR, Rudge MVC, Barbosa AMP; Diamater Study Group. Gestational diabetes is associated with alteration on pelvic floor muscle activation pattern during pregnancy and postpartum: Prospective cohort using electromyography assessment. Front Endocrinol (Lausanne). 2022 Oct 6;13:958909. doi: 10.3389/fendo.2022.958909. eCollection 2022.
PubMed 36277705Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Aug;229(2):158.e1-158.e14. doi: 10.1016/j.ajog.2023.01.037. Epub 2023 Feb 8.
PubMed 36758710Modzelewski R, Stefanowicz-Rutkowska MM, Matuszewski W, Bandurska-Stankiewicz EM. Gestational Diabetes Mellitus-Recent Literature Review. J Clin Med. 2022 Sep 28;11(19):5736. doi: 10.3390/jcm11195736.
PubMed 36233604Lu Y, Huang J, Yan J, Wei Q, He M, Yuan C, Long Y. Meta-analysis of risk factors for recurrent gestational diabetes mellitus. BMC Pregnancy Childbirth. 2025 Mar 8;25(1):257. doi: 10.1186/s12884-025-07367-9.
PubMed 40057727Huifen Z, Yaping X, Meijing Z, Huibin H, Chunhong L, Fengfeng H, Yaping Z. Effects of moderate-intensity resistance exercise on blood glucose and pregnancy outcome in patients with gestational diabetes mellitus: A randomized controlled trial. J Diabetes Complications. 2022 May;36(5):108186. doi: 10.1016/j.jdiacomp.2022.108186. Epub 2022 Mar 29.
PubMed 35379538Dipla K, Zafeiridis A, Mintziori G, Boutou AK, Goulis DG, Hackney AC. Exercise as a Therapeutic Intervention in Gestational Diabetes Mellitus. Endocrines. 2021 Jun;2(2):65-78. doi: 10.3390/endocrines2020007. Epub 2021 Mar 26.
PubMed 33870263Arslan M, Kozan R. Pelvic floor dysfunction in patients with gestational diabetes mellitus. World J Diabetes. 2025 Feb 15;16(2):99823. doi: 10.4239/wjd.v16.i2.99823.
PubMed 39959261Adnan M, Aasim M. Prevalence of gestational diabetes mellitus in Pakistan: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2024 Feb 3;24(1):108. doi: 10.1186/s12884-024-06290-9.
PubMed 38310244