Exercise and Lumbopelvic Mobility in Pregnancy (NCT07447466) | Clinical Trial Compass
CompletedNot Applicable
Exercise and Lumbopelvic Mobility in Pregnancy
Tunisia50 participantsStarted 2024-09-15
Plain-language summary
Introduction. Pregnancy-induced biomechanical alterations frequently precipitate lumbopelvic mobility restrictions, contributing to musculoskeletal dysfunction and compromised maternal quality of life. This investigation evaluated whether a structured therapeutic exercise rehabilitation protocol could counteract gestational mobility decline and enhance lumbopelvic range of motion in second-trimester pregnant women through targeted neuromuscular conditioning.
Methods. A randomized controlled trial enrolled 50 pregnant women (gestational age mean±standard deviation (range): 22±5 (14 -31) weeks) allocated to experimental (n=25) or control (n=25) groups. The experimental group completed a six-week progressive resistance exercise rehabilitation program (36 supervised sessions) targeting lumbopelvic stabilizers, paraspinal musculature, and hip girdle complexes. Primary outcomes comprised eight goniometrically assessed range of motion parameters across sagittal (ie.; lumbar flexion and extension), frontal (ie.; lumbar right and left lateral flexion), and transverse (ie.; right and left axial rotation) anatomical planes, anterior and posterior pelvic tilt. Secondary outcomes comprised back and pelvic pain. All outcomes were measured at baseline, midintervention (week 3), and postintervention (week 6). Percentage changes between postintervention and baseline were calculated.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* specified singleton intrauterine pregnancies confirmed ultrasonographically
* gestational age between 14 and 28 weeks calculated from last menstrual period and corroborated by first-trimester ultrasound biometry
* absence of diagnosed musculoskeletal pathology requiring medical intervention
* medical clearance for moderate-intensity aerobic and resistance exercise from attending obstetricians
* capacity to commit to supervised exercise sessions six days weekly for six consecutive weeks
Exclusion Criteria:
* encompassed high-risk pregnancy classifications including placenta previa
* pregnancy-induced arterial hypertension or preeclampsia (systolic blood pressure ≥140 mmHg or diastolic ≥90 mmHg with proteinuria
* gestational diabetes mellitus requiring insulin therapy
* multiple gestation
* incompetent cervix or cerclage placement
* persistent second-trimester vaginal bleeding
* premature rupture of membranes
* history of preterm labor
* intrauterine growth restriction below tenth percentile
* contraindications to exercise per American College of Obstetricians and Gynecologists guidelines
* concurrent participation in structured exercise programs exceeding 60 minutes weekly
* acute lumbopelvic pain intensity exceeding six on numerical rating scale (0 to 10) necessitating pharmacological management
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lumbopelvic range of motion
Timeframe: All outcomes were measured at baseline, midintervention (week 3), and postintervention (week 6)
2
Back and pelvic pain changes
Timeframe: Back and pelvic pain were measured at baseline, midintervention (week 3), and postintervention (week 6)