ClinicalTrials.gg
CompletedNCT07447466Updated Mar 3, 2026

Exercise and Lumbopelvic Mobility in Pregnancy

An interventional study of Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy and Standard prenatal care in Lumbopelvic Range of Motion in Second-Trimester Pregnancy, sponsored by Habil Hamdouni. Completed at 1 site in Tunisia. Open to female participants. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Habil Hamdouni · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Sep 2024, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
Female
01

Study 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.

Read the detailed description

Low back pain and pelvic girdle pain constitute the most prevalent musculoskeletal complaints during pregnancy, collectively affecting 50% to 70% of pregnant women, with prevalence escalating substantially during second and third trimesters. These conditions exhibit multifactorial etiology involving altered biomechanics, compromised neuromuscular control, weakened core musculature, and progressive joint stiffness. The syndrome extends beyond subjective pain to encompass objective functional impairments including restricted lumbopelvic range of motion, compromised postural stability, reduced occupational capacity, increased sick leave utilization, and elevated fall risk, collectively imposing substantial individual and societal burdens. Biomechanical alterations include increased spinal loading (estimated at 56% elevation above non-pregnant baseline), hormonal mediation of ligamentous integrity affecting sacroiliac and pubic symphysis articulations, and neuromuscular control deficits impairing load transfer mechanisms across the lumbopelvic complex.

Therapeutic exercise has emerged as a cornerstone non-pharmacological intervention in prenatal care. Structured protocols targeting core stability, spinal mobility, and pelvic floor function demonstrate beneficial effects on pain reduction, postural optimization, and functional capacity preservation. A 2019 systematic reviews established that prenatal exercise reduces pain severity and improves functional capacity, though effects on symptom prevalence remain equivocal. Exercise enhances lumbopelvic stability through strengthening deep abdominal and paraspinal musculature, improving neuromuscular coordination and proprioceptive acuity, optimizing load distribution across compromised joints, and potentially modulating inflammatory cascades contributing to pain sensitization. Randomized controlled trials (RCT) indicated that combined stabilization and pelvic floor training surpasses isolated exercise approaches for improving lumbopelvic function and reducing disability.

The present investigation addressed these methodological limitations through a RCT design incorporating validated goniometric assessment of eight discrete lumbopelvic range of motion parameters across three temporal measurement points. The study compared outcomes between pregnant women participating in a structured six-week progressive resistance exercise program targeting lumbopelvic stabilizers and controls engaging only in routine daily activities. This design enables characterization of both intervention effects (comparing exercising (experimental group) vs. non-exercising group (control group) and natural gestational trajectories (examining temporal changes within the control group), thereby providing comprehensive evidence regarding therapeutic exercise efficacy and the biomechanical consequences of pregnancy progression in the absence of structured physical conditioning. The primary aim was to evaluate 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. The investigators hypothesized that the progressive resistance exercise intervention would generate substantial improvements in all measured lumbopelvic mobility parameters, while control participants would exhibit progressive restrictions as pregnancy advanced, resulting in large between-group differences favoring the intervention group at postintervention assessment. The secondary aim was to compare back and pelvic pain between the two groups.

02

Conditions studied

  • Lumbopelvic Range of Motion in Second-Trimester Pregnancy

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Keywords

  • Biomechanics
  • exercise therapy
  • goniometry
  • joint instability
  • musculoskeletal
  • manipulations
  • physical therapy modalities
  • postural balance
  • prenatal care
03

In context

Joint Instability

115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.

This study's enrollment of 50 is close to the median of 46 across 58 interventional studies indexed under Joint Instability.

Browse Joint Instability studies →

Lead sponsor

Habil Hamdouni is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Resistance training

    participated in a six-week progressive resistance exercise program

    Behavioral: Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy

  • Placebo comparator
    Control group

    received standard prenatal care without structured exercise prescription, engaging only in routine daily activities

    Behavioral: Standard prenatal care

Interventions

  • BehavioralEffectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy

    We hypothesized that the progressive resistance exercise intervention would generate substantial improvements in all measured lumbopelvic mobility parameters, while control participants would exhibit progressive restrictions as pregnancy advanced, resulting in large between-group differences favoring the intervention group at postintervention assessment. The secondary aim was to compare back and pelvic pain between the two groups.

  • BehavioralStandard prenatal care

    The control group received standard prenatal care without structured exercise prescription, engaging only in routine daily activities. Control group received counseling to maintain habitual activity patterns without intentional modification, avoiding initiation of new exercise programs during the study period

06

What researchers measure

Primary outcomes

  1. Lumbopelvic range of motion

    Lumbopelvic range of motion constituted eight discrete movement parameters across three anatomical planes consistent with standardized normative values * Lumbar spine sagittal plane flexion (0 to 80 degrees normative range) * Lumbar spine sagittal plane extension (0 to 30 degrees), * Lumbar spine frontal plane lateral flexion to right and left (0 to 40 degrees bilaterally), * Lumbar spine transverse plane axial rotation to right and left (0 to 45 degrees bilaterally) * Anterior pelvic tilt in sagittal plane (13±4.9 degrees population mean), and * Posterior pelvic tilt in sagittal plane (8.9±4.5 degrees population mean)

    Time frame: All outcomes were measured at baseline, midintervention (week 3), and postintervention (week 6)

  2. Back and pelvic pain changes

    The endpoint criterion required attainment of end-range position where participants reported substantial stretch sensation without pain (numerical rating scale intensity 4 to 5 of 10) (Hatano et al., 2022)maintained for two seconds

    Time frame: Back and pelvic pain were measured at baseline, midintervention (week 3), and postintervention (week 6)

07

Study locations

1 site
  • Institut Supérieur du Sport et de l'Education Physique de Ksar-Saïd
    Aryanah, Ariana Governorate 2073, Tunisia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Oct 2024, 1 month.

Of 36 non-industry interventional studies with no phase under Joint Instability, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 1 month is below that.

Counting every sponsor, half of 41 studies reached it within 15 months; a quarter within 7 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2026
First posted
Mar 3, 2026
StartActual
Sep 15, 2024
Primary completionActual
Oct 31, 2024
CompletionActual
Jan 20, 2025
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07447466
Lead sponsor
Habil Hamdouni
Collaborators
Faculty of Medicine, Sousse
Responsible party
Habil Hamdouni (Doctor, Institut Supérieur du Sport et de l'Education Physique de Ksar-Saïd) — Sponsor-investigator
First posted
Mar 3, 2026
Start date
Sep 15, 2024
Primary completion
Oct 31, 2024
Completion
Jan 20, 2025
Last update
Mar 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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