Lumbopelvic Range of Motion in Second-Trimester PregnancyNCT07447466
Exercise and Lumbopelvic Mobility in Pregnancy
A study testing Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy and Standard prenatal care in people with Lumbopelvic Range of Motion in Second-Trimester Pregnancy, run by Habil Hamdouni at 1 site in Tunisia.
Trial summary
Introduction. Pregnancy-induced biomechanical alterations frequently precipitate lumbopelvic mobility restrictions, contributing to musculoskeletal dysfunction and compromised maternal quality of life. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Lumbopelvic Range of Motion in Second-Trimester Pregnancy
- What is being tested?
- Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy and Standard prenatal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Sep 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Institut Supérieur du Sport et de l'Education Physique de Ksar-Saïd
Aryanah, Ariana Governorate, 2073
About this study
Official title: Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy: A Randomized Controlled Trial
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.
- Being tested
- Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy, Standard prenatal care
- Keywords
- Biomechanics, exercise therapy, goniometry, joint instability, musculoskeletal, manipulations, physical therapy modalities, postural balance, prenatal care
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester PregnancyBehavioural
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.
Standard prenatal careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | participated in a six-week progressive resistance exercise program Receives: 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 Receives: Behavioral: Standard prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Back and pelvic pain were measured at baseline, midintervention (week 3), and postintervention (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 Sep 2024
- Primary completion31 Oct 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbopelvic Range of Motion in Second-Trimester PregnancyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Habil Hamdouni
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Medicine, Sousse
- Responsible party
- Sponsor-investigator, Habil Hamdouni, Institut Supérieur du Sport et de l'Education Physique de Ksar-Saïd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447466
- Sponsor's protocol ID
- ERC-2024-076
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07447466
- Acronym / sponsor ID
- ERC-2024-076
- Keywords
- Biomechanics, exercise therapy, goniometry, joint instability, musculoskeletal, manipulations, physical therapy modalities, postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Habil HamdouniUniversity, hospital or other
- Collaborators
- Faculty of Medicine, Sousse
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Behavioral: Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancyparticipated in a six-week progressive resistance exercise program |
| Control group | Placebo comparator | Behavioral: Standard prenatal carereceived standard prenatal care without structured exercise prescription, engaging only in routine daily activities |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester PregnancyWe 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. | Behavioural | Resistance training |
| Standard prenatal careThe 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 | Behavioural | Control group |
Primary outcome
Lumbopelvic range of motion
Time frame: All outcomes were measured at baseline, midintervention (week 3), and postintervention (week 6)
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)
Back and pelvic pain changes
Time frame: Back and pelvic pain were measured at baseline, midintervention (week 3), and postintervention (week 6)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effectiveness of a Six-Week Progressive Resistance Exercise Program on Lumbopelvic Range of Motion in Second-Trimester Pregnancy and Standard prenatal care in people with Lumbopelvic Range of Motion in Second-Trimester Pregnancy, run by Habil Hamdouni at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbopelvic range of motion (time frame: All outcomes were measured at baseline, midintervention (week 3), and postintervention (week 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.