Empowering Postpartum Health Through Exercise

NCT07595380 | Enrolling By Invitation

• 1 other identifier: 27365
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postpartum; Posture; Depression; Body image; Exercise

Outcome Measures

Primary Outcomes (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.

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (3)

• Postural Sway

  From enrollment to the end of treatment at 24 weeks

• Postural Sway

  From enrollment to the end of treatment at 24 weeks

• Postural Sway

  From enrollment to the end of treatment at 24 weeks

Other Outcomes (13)

• Psychosocial parameters_Depression

  From enrollment to the end of treatment at 24 weeks

• Psychosocial parameters_Stress

  From enrollment to the end of treatment at 24 weeks

• Psychosocial parameters_Sleep

  From enrollment to the end of treatment at 24 weeks

Study Arms (3)

SENSOMOTOR training group (SEN Experimental Treatment 1)

EXPERIMENTAL

will follow a specific training program based on a combination of Pilates, GYROKINESIS®, and yoga.

Other: SENSOMOTOR training

COUNTER-RESISTANCE Training Group (CR Experimental Treatment 2)

ACTIVE COMPARATOR

will 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.

Other: Resistance Training

USUAL CARE (UC) Group

NO INTERVENTION

This 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.

Interventions

SENSOMOTOR training OTHER

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.

SENSOMOTOR training group (SEN Experimental Treatment 1)

Resistance Training OTHER

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.

COUNTER-RESISTANCE Training Group (CR Experimental Treatment 2)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rome Foro Italico: lead
• Isola Tiberina - Gemelli Isola Hospital, Rome, Italy: collaborator

Study Sites (1)

University of Rome "Foro Italico"

Roma, Roma, 00135, Italy

Location

MeSH Terms

Conditions

Depression; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elisa Grazioli

  University of Rome Foro Italico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: March 2027 and ending 1 years after the publication of results
• Access Criteria: Under request to the principal investigator

Locations

IT (1)