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临床试验/NCT07595380
NCT07595380Enrolling By Invitation不适用

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

University of Rome Foro Italico1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
45
试验地点
1
主要终点
Body Image Perception

研究概览

简要总结

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);

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

SENSOMOTOR training group (SEN Experimental Treatment 1)

Experimental

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

干预措施: SENSOMOTOR training (Other)

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.

干预措施: Resistance Training (Other)

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.

结局指标

主要结局

Body Image Perception

时间窗: 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.

次要结局

  • Postural Sway(From enrollment to the end of treatment at 24 weeks)

研究者

发起方
University of Rome Foro Italico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisa Grazioli

Associate Professor, PhD

University of Rome Foro Italico

研究点 (1)

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