Impact of Adapted Physical Activity Combined With Pelvic Floor Functionality on Pelvic Girdle Pain During Pregnancy: A Randomized Controlled Exploratory Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Pain Intensity (Visual Analog Scale, VAS)
研究概览
简要总结
Pelvic girdle pain (PGP) is a common condition during pregnancy, affecting up to two-thirds of women. It can cause significant discomfort, limit daily activities, and reduce quality of life. Current treatment options are limited, and many women continue to experience pain throughout pregnancy and even after childbirth.
This study will evaluate whether a structured program of adapted physical activity, with additional individualized pelvic floor rehabilitation when needed, can reduce pelvic girdle pain and improve function during pregnancy. The intervention consists of weekly 60-minute sessions of adapted physical activity, led by a pelvic health physiotherapist, from inclusion until 36-38 weeks of gestation. The exercises focus on lumbopelvic stability, mobility, strengthening, and safe aerobic activity. If a participant presents with pelvic floor dysfunction, individualized rehabilitation may be added in parallel.
Participants will be randomly assigned to either the intervention group (adapted physical activity ± pelvic floor rehabilitation) or a control group. The control group will receive standard pregnancy follow-up care plus a validated flyer with international recommendations on physical activity during pregnancy but without supervised sessions.
The primary outcomes are pain intensity and functional impact of PGP, measured using the Visual Analog Scale (VAS) and the Pelvic Girdle Questionnaire (PGQ). Secondary outcomes include self-reported physical activity, pelvic symptoms, pelvic floor function, adherence to the intervention, and acceptability of the program.
A total of 40 pregnant women will be enrolled at Hospital La Tour in Geneva, Switzerland. Assessments will take place at three time points: inclusion (≤27 weeks of gestation), late pregnancy (36-38 weeks), and 3 months after delivery.
The study is expected to provide new evidence on the benefits of integrating pelvic floor functionality into physical activity programs for pregnant women with PGP. If effective, this approach could inform clinical practice and improve care for women during pregnancy
详细描述
Background and Rationale
Pregnancy induces substantial morphological, hormonal, and biomechanical changes that increase the risk of musculoskeletal pain, particularly pelvic girdle pain (PGP). Up to 63% of pregnant women experience PGP, which may significantly affect mobility, quality of life, and psychological well-being. Although international guidelines, including those of the American College of Obstetricians and Gynecologists (ACOG), recommend physical activity during pregnancy, few interventions specifically target PGP, and the role of pelvic floor function has been largely overlooked.
The pelvic floor contributes to lumbopelvic stability through myofascial connections and motor control. Dysfunction of the pelvic floor muscles is frequently observed in women with PGP, with symptoms such as hypertonicity, poor endurance, and ineffective contractions. Evidence suggests an association between pelvic floor dysfunction and pelvic pain, but no trial to date has combined adapted physical activity with targeted pelvic floor rehabilitation in pregnant women with PGP.
Objectives
The primary objective of this exploratory randomized controlled trial is to evaluate the effect of a combined intervention (adapted physical activity with optional individualized pelvic floor rehabilitation) on pain intensity and functional impact of PGP during pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label trial. Neither participants nor investigators are blinded to group assignment due to the nature of the intervention (supervised physical activity and rehabilitation). Outcome assessments are self-reported or clinician-administered and not masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged ≥18 years
- •Gestational age ≤27 weeks at enrollment
- •Clinically confirmed pelvic girdle pain, defined as:
- •Pain localized between the posterior iliac crest and the gluteal fold, particularly around the sacroiliac joints and/or pubic symphysis, Pain intensity ≥3/10 on Visual Analog Scale (VAS), At least 3 positive clinical tests among: Posterior Pelvic Pain Provocation (P4) test, Patrick's FABER, Menell's test, Active Straight Leg Raise (ASLR), and palpation of long dorsal sacroiliac ligament or symphysis pubis
- •Ability to understand and provide written informed consent
排除标准
- •Isolated low back pain without pelvic involvement
- •Contraindications to exercise during pregnancy (e.g., severe preeclampsia, placenta previa after 26 weeks, risk of preterm labor, ruptured membranes, significant cardiac or pulmonary disease)
- •Neurological, rheumatologic, or orthopedic conditions that may interfere with participation
- •Insufficient French language proficiency to understand questionnaires and instructions
- •Participation in another interventional study that could affect outcomes
研究组 & 干预措施
Adapted Physical Activity with or without Pelvic Floor Rehabilitation
Participants attend weekly 60-minute sessions of adapted physical activity, from enrollment (≤27 weeks gestation) until 36-38 weeks of pregnancy. Sessions alternate between land and aquatic settings and include mobility, lumbopelvic stabilization, core and multifidus strengthening, and safe aerobic training. If pelvic floor dysfunction is identified at baseline using the Pelvic Floor Distress Inventory (PFDI-20), participants will also receive individualized pelvic floor rehabilitation (up to 9 sessions) focusing on pelvic floor muscle relaxation, strengthening, and coordination.
干预措施: Adapted Physical Activity (Behavioral)
Adapted Physical Activity with or without Pelvic Floor Rehabilitation
Participants attend weekly 60-minute sessions of adapted physical activity, from enrollment (≤27 weeks gestation) until 36-38 weeks of pregnancy. Sessions alternate between land and aquatic settings and include mobility, lumbopelvic stabilization, core and multifidus strengthening, and safe aerobic training. If pelvic floor dysfunction is identified at baseline using the Pelvic Floor Distress Inventory (PFDI-20), participants will also receive individualized pelvic floor rehabilitation (up to 9 sessions) focusing on pelvic floor muscle relaxation, strengthening, and coordination.
干预措施: Pelvic Floor Rehabilitation (Behavioral)
Standard Care and Educational Flyer
Participants receive standard prenatal care as provided by their healthcare providers. In addition, they are given a validated flyer containing international recommendations for safe physical activity during pregnancy. No supervised physiotherapy or structured exercise sessions are provided.
干预措施: Standard Care (in control arm) (Other)
Standard Care and Educational Flyer
Participants receive standard prenatal care as provided by their healthcare providers. In addition, they are given a validated flyer containing international recommendations for safe physical activity during pregnancy. No supervised physiotherapy or structured exercise sessions are provided.
干预措施: Educational Flyer (Other)
结局指标
主要结局
Pain Intensity (Visual Analog Scale, VAS)
时间窗: Baseline (≤27 weeks gestation), 36-38 weeks gestation and 3 months postpartum.
Pain intensity related to pelvic girdle pain measured on a 10 cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).
Functional Impact of Pelvic Girdle Pain (Pelvic Girdle Questionnaire, PGQ)
时间窗: Baseline, Gestational Weeks 36-38 and 3 months postpartum.
Functional disability and symptoms assessed with the 25-item Pelvic Girdle Questionnaire (PGQ, score range 0-100; higher scores indicate greater disability).
次要结局
- Physical Activity (Pregnancy Physical Activity Questionnaire, PPAQ)(Baseline, Gestational Weeks 36-38 and 3 months postpartum.)
- Pelvic Symptoms (Pelvic Floor Distress Inventory, PFDI-20)(Baseline, Gestational Weeks 36-38 and 3 months postpartum.)
- Adherence to Intervention(During pregnancy until 36-38 weeks gestation.)
- Acceptability of Intervention(At 36-38 weeks gestation.)
- Pelvic Floor Function (PERFECT Scheme)(Baseline and Gestational Weeks 36-38)