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Набор скоро начнётся NCT07253844

Effects of Transverse Abdominis Activation and Rectus Abdominis Strengthening on Inter-rectus Distance and Core Stability

Без фазы С лечением Diastasis Recti Abdominis (DRA)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transverse Abdominis activation exercises, Rectus Abdominis Strengthening exercises, combined protocol of both transverse abdominis activation and rectus abdominis strengthening..
Кому может быть актуально
Состояния в реестре: Diastasis Recti Abdominis (DRA). Базовые параметры: 20 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Transverse Abdominis Activation and Rectus Abdominis Strengthening on Inter-rectus Distance and Core Stability Among Patients With Diastasis Rectus Abdominis

Обзор

This randomized controlled trial aims to compare the effects of Transverse Abdominis (TrA) activation, Rectus Abdominis (RA) strengthening, and their combined approach on inter-rectus distance (IRD) and core stability in postpartum women diagnosed with diastasis rectus abdominis (DRA). Thirty-three participants will be randomly allocated into three groups and will complete a six-week exercise program at the Pakistan Society for the Rehabilitation of the Disabled (PSRD) Hospital, Lahore. The study will use real-time ultrasound and pressure biofeedback assessment to evaluate changes in IRD and core stability. It is hypothesized that TrA activation and the combined intervention will produce greater improvements compared to RA strengthening alone.

Подробное описание

Background and Rationale:

Diastasis Rectus Abdominis (DRA) is a prevalent postpartum musculoskeletal condition characterized by the separation of the rectus abdominis muscles along the linea alba, resulting in impaired trunk stability, abdominal weakness, and postural dysfunction. Despite its high prevalence, DRA remains underdiagnosed and undertreated, particularly in developing countries where structured rehabilitation protocols are lacking. Physiotherapy-based interventions focusing on abdominal muscle retraining and core stability have been shown to improve outcomes; however, the relative effectiveness of Transverse Abdominis (TrA) activation, Rectus Abdominis (RA) strengthening, and their combined approach remains uncertain.

Objectives:

This randomized controlled trial aims to compare the effects of TrA activation, RA strengthening, and their combination on inter-rectus distance (IRD) and core stability among postpartum women with DRA.

Methods:

This three-arm, parallel-group randomized controlled trial will be conducted at the Pakistan Society for the Rehabilitation of the Disabled (PSRD) Hospital, Lahore, Pakistan. A total of 33 postpartum women aged 20-40 years, diagnosed with DRA (6 months to 2 years postpartum), will be recruited using non-probability convenience sampling. Participants will be randomly assigned into three groups (n = 11 per group):

Group A (TAA): Transverse Abdominis Activation exercises

Group B (RAS): Rectus Abdominis Strengthening exercises

Group C (TAA + RAS): Combined TrA activation and RA strengthening protocol

Each participant will undergo a 6-week intervention program, including three supervised sessions per week for 3 weeks, followed by a 3-week home exercise program. Each session will last 30-45 minutes and will be supervised by a licensed physical therapist at PSRD.

Outcome Measures:

Primary Outcome: Change in Inter-Rectus Distance (IRD), measured via real-time ultrasound imaging (7.5 MHz linear probe) at three anatomical sites (4.5 cm above, at, and 4.5 cm below the umbilicus), pre- and post-intervention.

Secondary Outcome: Core stability, assessed using a Pressure Biofeedback Unit (PBU) during the abdominal drawing-in maneuver (ADIM) in crook-lying position. Participants will aim to reduce pressure by 6-10 mmHg from a 40 mmHg baseline and sustain the contraction for 10 seconds; the mean of three trials will be recorded.

Randomization and Blinding:

Participants will be randomized using Randomized Allocation Software (Version 1.0) in a 1:1:1 ratio. Due to the exercise-based nature of the interventions, blinding of participants and therapists is not feasible; however, the outcome assessor will remain blinded to group assignments, ensuring a single-blind design.

Data Analysis:

Statistical analysis will be performed using SPSS version 26. Data will first be tested for normality using the Shapiro-Wilk test. A two-way mixed ANOVA will be applied to assess both within-subject effects (time: pre vs. post) and between-subject effects (group: TAA, RAS, TAA+RAS), as well as the interaction effect (time × group) on IRD and core stability outcomes. Post-hoc pairwise comparisons with Bonferroni correction will identify specific between-group differences. Statistical significance will be set at p \< 0.05 with a 95% confidence interval.

Expected Clinical Significance:

It is hypothesized that TrA activation exercises will lead to a greater reduction in IRD and improvement in core stability compared to RA strengthening alone. The combined exercise group (TAA + RAS) is expected to demonstrate the most comprehensive benefits due to synergistic activation of both deep and superficial abdominal muscles. The study outcomes are anticipated to provide evidence-based guidance for physiotherapists in postpartum rehabilitation, contributing to the development of standardized, non-invasive exercise protocols for DRA management and improved quality of life in postpartum women.

Вмешательства

  • Другое Transverse Abdominis activation exercises
    Group A (TAA) will perform abdominal drawing-in maneuvers (ADIM) in crook lying, side lying, and quadruped positions. They will be instructed to gently draw the belly button inward toward the spine without moving the pelvis or rib cage, emphasizing breathing coordination and pelvic floor co-activation. In the supervised phase, participants will perform 3 sets of 10 repetitions, with each contraction held for 10-20 seconds, and a rest interval of 3 minutes between sets
  • Другое Rectus Abdominis Strengthening exercises
    Group B (RAS) will perform exercises in supine lying with knees bent, including partial curl-ups, reverse crunches, pelvic tilts, and leg raises with abdominal bracing. The command will be tighten your abdominals as if bracing for a punch, and lift without straining your neck. Each supervised session will include 3 sets of 10-15 repetitions per exercise, progressing in difficulty using added resistance if tolerated, with a 3-minute rest interval between sets
  • Другое combined protocol of both transverse abdominis activation and rectus abdominis strengthening.
    Group C (TAA+RAS) will perform a hybrid protocol integrating both TrA activation and RA strengthening exercises. Each session will begin with ADIM in crook lying, side lying, and quadruped positions, followed by RA exercises including curl-ups, pelvic tilts, and leg raises. The command will be to activate your deep core with breathing, then strengthen your outer abdominals through controlled movements. Each supervised session will consist of 3 sets of 10 repetitions for TrA exercises (10-20 seco

Первичные конечные точки

  • Inter-rectus Distance (IRD) [Срок оценки: Baseline: Before starting the intervention Post-intervention: At the end of 6 weeks of the exercise program]
Вторичные конечные точки (1)
  • Core stability [Срок оценки: Baseline (pre-intervention) and 6 weeks (post-intervention)]

Критерии участия

Критерии включения

. Postpartum women diagnosed with DRA

  • Multigravida
  • Delivered a singleton pregnancy via vaginal breech or instrumental delivery

Критерии исключения

. Pregnancy

  • Abdominal and pelvic hernias or severe musculoskeletal conditions
  • Patients with abdominal and pelvic surgery
  • Patients with disc herniation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 2 центра
  • Lahore University of biological and applied sciences — Lahore
  • Pakistan Society for Rehabilitation of Differently Abled — Lahore

Публикации

  • Benjamin DR, Frawley HC, Shields N, van de Water ATM, Taylor NF. Relationship between diastasis of the rectus abdominis muscle (DRAM) and musculoskeletal dysfunctions, pain and quality of life: a systematic review. Physiotherapy. 2019 Mar;105(1):24-34. doi: 10.1016/j.physio.2018.07.002. Epub 2018 Jul 24. PMID 30217494
  • Olsson A, Woxnerud K, Kiwanuka O, Sandblom G, Stackelberg O. The TOR concept (training, operation, and rehabilitation) applied to a cohort of postpartum women with training-resistant symptomatic rectus diastasis: evaluation 1 year after surgery. BJS Open. 2023 Jan 6;7(1):zrac162. doi: 10.1093/bjsopen/zrac162. PMID 36734959
  • Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008. PMID 29351646
  • Pascoal AG, Dionisio S, Cordeiro F, Mota P. Inter-rectus distance in postpartum women can be reduced by isometric contraction of the abdominal muscles: a preliminary case-control study. Physiotherapy. 2014 Dec;100(4):344-8. doi: 10.1016/j.physio.2013.11.006. Epub 2014 Jan 18. PMID 24559692
  • Berg-Poppe P, Hauer M, Jones C, Munger M, Wethor C. Use of exercise in the management of postpartum diastasis recti: a systematic review. The Journal of Women's & Pelvic Health Physical Therapy. 2022;46(1):35-47.

Идентификаторы

NCT: NCT07253844 · UBAS/ERB/FoRS/25/025

Первоисточники (государственные реестры)

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