Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:51 PM
Study NCT ID:
NCT07447466
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Lumbopelvic Mobility in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007593', 'term': 'Joint Instability'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011262', 'term': 'Pregnancy Trimester, Second'}], 'ancestors': [{'id': 'D011264', 'term': 'Pregnancy Trimesters'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors conducting goniometric measurements maintained blinding to group allocation through sequential participant coding and spatial separation of assessment and intervention facilities'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-21', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lumbopelvic range of motion', 'timeFrame': 'All outcomes were measured at baseline, midintervention (week 3), and postintervention (week 6)', 'description': 'Lumbopelvic range of motion constituted eight discrete movement parameters across three anatomical planes consistent with standardized normative values\n\n* Lumbar spine sagittal plane flexion (0 to 80 degrees normative range)\n* Lumbar spine sagittal plane extension (0 to 30 degrees),\n* Lumbar spine frontal plane lateral flexion to right and left (0 to 40 degrees bilaterally),\n* Lumbar spine transverse plane axial rotation to right and left (0 to 45 degrees bilaterally)\n* Anterior pelvic tilt in sagittal plane (13±4.9 degrees population mean), and\n* Posterior pelvic tilt in sagittal plane (8.9±4.5 degrees population mean)'}, {'measure': 'Back and pelvic pain changes', 'timeFrame': 'Back and pelvic pain were measured at baseline, midintervention (week 3), and postintervention (week 6)', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biomechanics', 'exercise therapy', 'goniometry', 'joint instability', 'musculoskeletal', 'manipulations', 'physical therapy modalities', 'postural balance', 'prenatal care'], 'conditions': ['Lumbopelvic Range of Motion in Second-Trimester Pregnancy']}, 'descriptionModule': {'briefSummary': '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.\n\nMethods. 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.', 'detailedDescription': '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.\n\nTherapeutic 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Enrollment is limited to pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* specified singleton intrauterine pregnancies confirmed ultrasonographically\n* gestational age between 14 and 28 weeks calculated from last menstrual period and corroborated by first-trimester ultrasound biometry\n* absence of diagnosed musculoskeletal pathology requiring medical intervention\n* medical clearance for moderate-intensity aerobic and resistance exercise from attending obstetricians\n* capacity to commit to supervised exercise sessions six days weekly for six consecutive weeks\n\nExclusion Criteria:\n\n* encompassed high-risk pregnancy classifications including placenta previa\n* pregnancy-induced arterial hypertension or preeclampsia (systolic blood pressure ≥140 mmHg or diastolic ≥90 mmHg with proteinuria\n* gestational diabetes mellitus requiring insulin therapy\n* multiple gestation\n* incompetent cervix or cerclage placement\n* persistent second-trimester vaginal bleeding\n* premature rupture of membranes\n* history of preterm labor\n* intrauterine growth restriction below tenth percentile\n* contraindications to exercise per American College of Obstetricians and Gynecologists guidelines\n* concurrent participation in structured exercise programs exceeding 60 minutes weekly\n* acute lumbopelvic pain intensity exceeding six on numerical rating scale (0 to 10) necessitating pharmacological management'}, 'identificationModule': {'nctId': 'NCT07447466', 'briefTitle': 'Exercise and Lumbopelvic Mobility in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': "Institut Supérieur du Sport et de l'Education Physique de Ksar-Saïd"}, 'officialTitle': 'Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ERC-2024-076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance training', 'description': 'participated in a six-week progressive resistance exercise program', 'interventionNames': ['Behavioral: Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'received standard prenatal care without structured exercise prescription, engaging only in routine daily activities', 'interventionNames': ['Behavioral: Standard prenatal care']}], 'interventions': [{'name': 'Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Resistance training']}, {'name': 'Standard prenatal care', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2073', 'city': 'Aryanah', 'state': 'Ariana Governorate', 'country': 'Tunisia', 'facility': "Institut Supérieur du Sport et de l'Education Physique de Ksar-Saïd", 'geoPoint': {'lat': 36.86012, 'lon': 10.19337}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Habil Hamdouni', 'class': 'OTHER'}, 'collaborators': [{'name': 'Faculty of Medicine, Sousse', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Habil Hamdouni', 'investigatorAffiliation': "Institut Supérieur du Sport et de l'Education Physique de Ksar-Saïd"}}}}