Empowering Postpartum Health Through Exercise

NCT07595380 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-05-19

No results posted yet for this study

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. 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.

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);

Conditions

  • No Condition, Healthy Females

Interventions

OTHER

SENSOMOTOR training

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.

OTHER

Resistance Training

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.

Sponsors & Collaborators

  • Isola Tiberina - Gemelli Isola Hospital, Rome, Italy

    collaborator OTHER
  • University of Rome Foro Italico

    lead OTHER

Principal Investigators

  • Elisa Grazioli · University of Rome Foro Italico

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-06-01
Completion
2028-10-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595380 on ClinicalTrials.gov