Empowering Postpartum Health Through Exercise (EMPOWEX)
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.
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);
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Roma
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Roma、Roma、イタリア、00135
- University of Rome "Foro Italico"
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：SENSOMOTOR training group (SEN Experimental Treatment 1)
will follow a specific training program based on a combination of Pilates, GYROKINESIS®, and yoga.
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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.
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アクティブコンパレータ：COUNTER-RESISTANCE Training Group (CR Experimental Treatment 2)
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.
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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.
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介入なし：USUAL CARE (UC) Group
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body Image Perception
時間枠：From enrollment to the end of treatment at 24 weeks
|
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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postural Sway
時間枠：From enrollment to the end of treatment at 24 weeks
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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. |
From enrollment to the end of treatment at 24 weeks
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Postural Sway
時間枠：From enrollment to the end of treatment at 24 weeks
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Change from baseline in postural sway parameters measured by inertial sensors (Gyko). Outcomes include mean velocity (mm/s) during static balance tasks. |
From enrollment to the end of treatment at 24 weeks
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Postural Sway
時間枠：From enrollment to the end of treatment at 24 weeks
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Change from baseline in postural sway parameters measured by inertial sensors (Gyko). Outcomes include Ellipse Area (mm²) during static balance tasks. |
From enrollment to the end of treatment at 24 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Psychosocial parameters_Depression
時間枠：From enrollment to the end of treatment at 24 weeks
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Change in depressive symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS).
The EPDS score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.
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From enrollment to the end of treatment at 24 weeks
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Psychosocial parameters_Stress
時間枠：From enrollment to the end of treatment at 24 weeks
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Change in perceived stress measured by the Perceived Stress Scale (PSS-10).
The PSS-10 score ranges from 0 to 40, with higher scores indicating greater perceived stress.
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From enrollment to the end of treatment at 24 weeks
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Psychosocial parameters_Sleep
時間枠：From enrollment to the end of treatment at 24 weeks
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Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI).
The PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
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From enrollment to the end of treatment at 24 weeks
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Psychosocial parameters_QoL
時間枠：From enrollment to the end of treatment at 24 weeks
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Change in quality of life measured by the Short Form Health Survey (SF-36).
Scores range from 0 to 100 for each domain, with higher scores indicating better health-related quality of life.
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From enrollment to the end of treatment at 24 weeks
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Functional Paramteres_Balance
時間枠：From enrollment to the end of treatment at 24 weeks
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Balance performance measured by Single-Leg Stance (seconds).
Higher values indicate better balance performance.
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From enrollment to the end of treatment at 24 weeks
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Functional Paramteres_Balance2
時間枠：From enrollment to the end of treatment at 24 weeks
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Functional balance measured by Step Test (number of steps).
Higher values indicate better functional balance performance.
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From enrollment to the end of treatment at 24 weeks
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Functional Paramteres_Strength
時間枠：From enrollment to the end of treatment at 24 weeks
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Muscular strength measured by handgrip dynamometry (kg).
Higher values indicate greater muscle strength.
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From enrollment to the end of treatment at 24 weeks
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Functional Paramteres_Strength2
時間枠：From enrollment to the end of treatment at 24 weeks
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Lower limb functional strength measured by the 30-Second Sit-to-Stand Test (number of repetitions). Higher values indicate better lower limb functional strength. |
From enrollment to the end of treatment at 24 weeks
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Functional Paramteres_Flexibility
時間枠：From enrollment to the end of treatment at 24 weeks
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Flexibility measured by Sit-and-Reach Test (cm).
Higher values indicate greater flexibility.
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From enrollment to the end of treatment at 24 weeks
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Functional Paramteres_Flexibility2
時間枠：From enrollment to the end of treatment at 24 weeks
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Upper body flexibility measured by Back Scratch Test (cm).
Lower values indicate greater flexibility.
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From enrollment to the end of treatment at 24 weeks
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Body Composition Analysis_FAT
時間枠：From enrollment to the end of treatment at 24 weeks
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Change from baseline in body composition assessed by bioelectrical impedance analysis (BIA). Outcomes include fat mass (Kg) |
From enrollment to the end of treatment at 24 weeks
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Body Composition Analysis_FFM
時間枠：From enrollment to the end of treatment at 24 weeks
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Change from baseline in body composition assessed by bioelectrical impedance analysis (BIA). Outcomes include fat-free mass (kg) |
From enrollment to the end of treatment at 24 weeks
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Body Composition Analysis_Water
時間枠：From enrollment to the end of treatment at 24 weeks
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Change from baseline in body composition assessed by bioelectrical impedance analysis (BIA). Outcomes include total body water (L). |
From enrollment to the end of treatment at 24 weeks
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協力者と研究者
捜査官
- 主任研究者：Elisa Grazioli、University of Rome Foro Italico
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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その他の研究ID番号
- 27365
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IPD 共有サポート情報タイプ
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