Exercise and Lumbopelvic Mobility in Pregnancy

NCT07447466 | Completed DMC

• 1 other identifier: ERC-2024-076
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbopelvic Range of Motion in Second-Trimester Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

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

• 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

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

Study Arms (2)

Resistance training

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Behavioral: Standard prenatal care

Interventions

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

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.

Resistance training

Standard prenatal care BEHAVIORAL

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

Control group

Eligibility Criteria

• Gender Eligibility Details: Enrollment is limited to pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Habil Hamdouni: lead
• Faculty of Medicine, Sousse: collaborator

Study Sites (1)

Institut Supérieur du Sport et de l'Education Physique de Ksar-Saïd

Aryanah, Ariana Governorate, 2073, Tunisia

Location

MeSH Terms

Conditions

Joint Instability

Interventions

Pregnancy Trimester, Second

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnancy Trimesters; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors conducting goniometric measurements maintained blinding to group allocation through sequential participant coding and spatial separation of assessment and intervention facilities
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: Sample size determination utilized G\*Power version 3.1.9.7 software with parameters derived from prior therapeutic exercise interventions (Sonmezer et al., 2021) Following random assignment, baseline equivalence between groups underwent verification across anthropometric characteristics (chronological age, standing height, body mass) and gestational age through non-parametric tests

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: March 3, 2026
• Study Start: September 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: January 20, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

TU (1)