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No Condition, Healthy FemalesEMPOWEXNCT07595380

Empowering Postpartum Health Through Exercise

A study testing SENSOMOTOR training and Resistance Training in people with No Condition, Healthy Females, run by University of Rome Foro Italico at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this randomized controlled clinical trial is to investigate the multidimensional recovery process in postpartum women, with particular focus on body image perception, postural alignment, psychological well-being, and functional capacity. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
No Condition, Healthy Females
What is being tested?
SENSOMOTOR training and Resistance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteItaly
Study dates
1 May 2026to 30 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women aged 18-45 years
  • Third trimester of pregnancy
  • Physical activity level <150 minutes per week
  • Ability to participate in exercise training
  • No contraindications to physical activity

Who cannot join

  • Severe comorbidities or medical conditions limiting exercise
  • Participation in structured exercise programs exceeding 150 minutes per week
  • Any contraindication to physical activity as determined by medical evaluation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site
  • University of Rome "Foro Italico"

    Roma, Roma, 00135

Other trials in Italy

About this study

Official title: Physical Activity for Women's Health: Effects of a Sensorimotor Program on Body Image and Posture in Postpartum Women

The goal of this randomized controlled clinical trial is to investigate the multidimensional recovery process in postpartum women, with particular focus on body image perception, postural alignment, psychological well-being, and functional capacity. The study aims to evaluate how different structured exercise approaches may influence these interconnected domains during the postpartum period, which is characterized by profound physical, physiological, and psychological adaptations.

The study will include women aged 18-45 years, recruited during the third trimester of pregnancy and followed up to 9 months postpartum. Eligible participants will present low levels of physical activity (<150 minutes/week) and no contraindications to exercise. This population is considered particularly vulnerable due to the coexistence of musculoskeletal changes, fatigue, altered body perception, and increased risk of psychological distress during the postpartum period.

Read more

The main questions it aims to answer are:

  • Can structured exercise interventions influence body image perception and postural alignment in postpartum women, as assessed by validated tools such as the Body Image Dimensional Assessment (BIDA) and instrumental analysis (Moti Physio system and Gyko inertial sensor)?
  • Can these interventions impact on psychological well-being and quality of life, including depression, stress, sleep quality, and perceived fatigue, as evaluated through standardized questionnaires (EPDS, PSS, PSQI, SF-36) and functional performance tests? Researchers will compare a sensorimotor training group (SEN), a resistance training group (CR), and a usual care control group (UC) to identify differences in psychological, postural, physiological, and functional outcomes, and to better understand the role of exercise type in postpartum recovery.

Researchers will compare a sensorimotor training group (SEN), a resistance training group (CR), and a usual care control group (UC) to identify differences in psychological, postural, physiological, and functional outcomes, and to better understand the role of exercise type in postpartum recovery. Both training interventions are designed to be safe, adaptable, and suitable for postpartum women.

Outcomes will be assessed at baseline (third trimester), pre-intervention (3 months postpartum), mid-intervention (6 months postpartum), post-intervention (9 months postpartum), and at 6-month follow-up. Particular attention will be given to the interaction between subjective outcomes (e.g., body image perception) and objective measures (e.g., posture and body composition), in order to provide a comprehensive understanding of postpartum recovery trajectories.

Participants will:

  • participate in a 24-week supervised exercise intervention (sensorimotor or resistance training, 2 sessions/week), or receive standard care recommendations (control group).
  • complete body image questionnaires (BIDA) at each time point to evaluate subjective perception of body changes;
  • perform postural assessments using non-invasive technologies (Moti Physio for spinal alignment and Gyko inertial sensors for kinematic and postural analysis);
  • undergo body composition assessment using bioelectrical impedance analysis (BIA), providing measures such as fat mass, fat-free mass, and total body water;
  • undergo repeated psychological assessments, including physical activity levels (IPAQ), depression (EPDS), perceived stress (PSS), sleep quality (PSQI), and quality of life (SF-36);
  • undergo functional testing, including balance (e.g., step test, single-leg stance), muscular strength (e.g., handgrip dynamometry, sit-to-stand test), and flexibility (sit-and-reach, scratch test);
Read the detailed description

INTRODUCTION The postpartum period is characterized by significant physical, physiological, and psychological changes that may affect body image, postural alignment, functional capacity, and overall well-being. Recovery during this phase is complex and may extend for several months after childbirth, with variability depending on individual conditions and delivery characteristics. Women in the postpartum period may experience musculoskeletal alterations, reduced core stability, fatigue, and changes in body perception, which can negatively influence daily functioning and quality of life. In addition, psychological factors such as stress, sleep disturbances, and depressive symptoms may further impact recovery and adaptation to the maternal role. Despite the recognized importance of physical recovery after childbirth, structured exercise interventions in the postpartum period are often not systematically implemented or tailored to the multidimensional needs of women. In particular, conventional exercise approaches may not fully address aspects such as proprioception, postural control, and body awareness. For this reason, there is increasing interest in integrated exercise models that combine elements of neuromuscular control, breathing, and movement coordination. Sensorimotor approaches, including methods based on controlled and multi-planar movements, may represent a suitable strategy to support both physical and perceptual recovery during the postpartum period. This study is designed to investigate the effects of different structured exercise interventions on multiple domains of postpartum recovery, including body image, posture, psychological well-being, body composition, and functional performance.

RESEARCH OBJECTIVES This randomized controlled trial aims to evaluate the effects of two structured exercise interventions on multiple domains of postpartum recovery, including body image, postural alignment, body composition, psychological well-being, and functional capacity. Participants will be randomly assigned to one of three groups: an integrated sensorimotor training group, a resistance training group, or a usual care group. The study is designed to compare the effects of these interventions on physical, perceptual, and psychological outcomes during the postpartum period. The sensorimotor training group will follow a 24-week program based on a combination of Pilates, GYROKINESIS®, and Yoga, focusing on proprioception, breathing control, and neuromuscular coordination. The resistance training group will perform a structured strength training program targeting major muscle groups through progressive exercises. The usual care group will receive standard postpartum recommendations without participating in a supervised exercise program.

A total of 45 women will be enrolled and equally allocated across the three study groups.

Assessments will be conducted at multiple time points: during the third trimester of pregnancy (baseline), at 3 months postpartum (pre-intervention), at 6 months postpartum (mid-intervention), at 9 months postpartum (post-intervention), and at 6 months after the end of the intervention (follow-up). Outcome domains include body image, postural parameters, body composition, psychological health, physical activity levels, and functional performance. These measures will be used to evaluate changes over time and to compare the effects of the different interventions.

METHODS Participants will be recruited through the Obstetrics and Obstetric Pathology Unit at the Isola Tiberina Gemelli-Isola Hospital. Recruitment will target women in the third trimester of pregnancy who meet the study eligibility criteria. Eligible participants will be enrolled and followed from late pregnancy through the postpartum period according to the study timeline. After baseline and pre-intervention assessments, participants will be randomly assigned to one of the three study groups. All participants will receive detailed information about the study procedures prior to enrollment and will provide written informed consent before participation. Data will be collected and managed using coded identifiers to ensure participant confidentiality. Only data relevant to the study objectives will be collected. The study will be conducted following approval by the appropriate ethics committee.

PARTICIPANTS AND SAMPLE SIZE The study aims to enroll a total of 45 participants, who will be randomly assigned in equal numbers to three study groups. The sample size was determined based on an a priori power analysis, taking into account expected effect size, significance level, and repeated measurements over time, in order to ensure adequate statistical power.

EVALUATION AND TRAINING PROTOCOL All participants will undergo baseline and follow-up assessments according to the study timeline. Assessments will include postural evaluation, body composition, psychological measures, and functional performance tests. Following baseline assessments, participants will be assigned to one of three study groups according to the study design. The two intervention groups will participate in supervised exercise programs conducted twice per week for 24 weeks. Each session will last approximately 60 minutes and will include one in-person session at the University of Rome "Foro Italico" and one remote session delivered online. Exercise sessions will be supervised by qualified professionals in preventive and adapted physical activity. The control group will not participate in supervised exercise sessions and will receive standard postpartum care recommendations.

COMPLIANCE

Adherence to the intervention will be assessed based on attendance at scheduled training sessions. Compliance will be categorized according to the percentage of completed sessions as follows:

  • High compliance: 75-100%
  • Moderate compliance: 50-74%
  • Low compliance: 25-49%
  • Very low compliance: 0-24%

STUDY RELEVANCE This study addresses the need to better understand the role of structured exercise interventions in supporting postpartum recovery across physical, psychological, and functional domains. By comparing different types of exercise approaches with usual care, the study aims to provide evidence on their potential impact on body image, postural alignment, and overall well-being in postpartum women. The findings may contribute to the development of more targeted and structured exercise programs to support recovery during the postpartum period.

Being tested
SENSOMOTOR training, Resistance Training
Keywords
Postpartum, Posture, Depression, Body image, Exercise
Medical subject headings
Depression, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SENSOMOTOR trainingOther

    Participants will follow a 24-week integrated sensorimotor training program combining principles of Pilates, Gyrokinesis®, and Yoga. The intervention is designed to enhance proprioception, motor control, breathing coordination, and postural alignment through controlled, low-impact, and fluid movements. Specific focus is placed on deep core activation (transversus abdominis, pelvic floor), spinal mobility, and neuromuscular coordination. Exercises include multi-planar movements, balance challenges, and breathing-integrated sequences. Sessions are performed twice weekly (one in-person, one online), lasting ~60 minutes, and are supervised by qualified exercise professionals.

  • Resistance TrainingOther

    Participants will engage in a structured 24-week resistance training program aimed at improving muscular strength and functional capacity. The protocol includes progressive exercises targeting major muscle groups (lower limbs, upper body, and core) using bodyweight, resistance bands, and light external loads. Intensity and volume will be progressively increased according to individual capacity. Sessions are conducted twice weekly (one in-person and one online), lasting approximately~60 minutes, and follow standard guidelines for postpartum exercise.

Study groups in NCT07595380
Study groupRoleWhat they receive
SENSOMOTOR training group (SEN Experimental Treatment 1)Experimentalwill follow a specific training program based on a combination of Pilates, GYROKINESIS®, and yoga.
Receives: Other: SENSOMOTOR training
COUNTER-RESISTANCE Training Group (CR Experimental Treatment 2)Active comparatorwill participate in a strength training program with counter-resistance exercises, already widely used in clinical practice and postpartum functional rehabilitation. This group allows for a comparison of the effects of the sensorimotor protocol with a validated and widely used treatment.
Receives: Other: Resistance Training
USUAL CARE (UC) GroupNo interventionThis group will not follow any structured program but will receive general usual care guidelines provided by medical staff. This group serves as a control and allows for distinguishing the specific effects of the two interventions compared to the absence of treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Image Perception

    Change from baseline in body image perception measured by the Body Image Dimensional Assessment (BIDA), expressed as Body Dissatisfaction Index (BDI).

    The BDI ranges from 0 to 100, with higher scores indicating greater body image dissatisfaction.

    Measured: From enrollment to the end of treatment at 24 weeks

Secondary outcomes (3)
  1. Postural Sway

    Change from baseline in postural sway parameters measured by inertial sensors (Gyko).

    Outcomes include root mean square (RMS) of sway (mm) during static balance tasks.

    Measured: From enrollment to the end of treatment at 24 weeks

  2. Postural Sway

    Change from baseline in postural sway parameters measured by inertial sensors (Gyko).

    Outcomes include mean velocity (mm/s) during static balance tasks.

    Measured: From enrollment to the end of treatment at 24 weeks

  3. Postural Sway

    Change from baseline in postural sway parameters measured by inertial sensors (Gyko).

    Outcomes include Ellipse Area (mm²) during static balance tasks.

    Measured: From enrollment to the end of treatment at 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

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
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07595380
Sponsor's protocol ID
27365
Acronym
EMPOWEX
Status last verified
May 2026
First submitted
16 Apr 2026
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Functional evaluation - Assessment

Questions about this trial

What is this clinical trial studying?

A study testing SENSOMOTOR training and Resistance Training in people with No Condition, Healthy Females, run by University of Rome Foro Italico at 1 site in Italy.

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 3 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: enrolling by invitation, as of the sponsor's last update on 19 May 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 Italy. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Body Image Perception (time frame: From enrollment to the end of treatment at 24 weeks). 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 19 May 2026.

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