Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training

NCT06286553 | Recruiting

• 1 other identifier: DRA Rehab TEG & IMT
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Diastasis Recti Abdominis (DRA) is the separation of the rectus muscles caused by stretching and thinning of the linea alba during pregnancy and childbirth. It's a common condition, affecting 66-100% of women post-birth and can persist for many years, leading to abdominal protrusion, discomfort, and aesthetic concerns. It might also contribute to back pain, urinary issues, and reduced abdominal strength, impacting quality of life. Recent guidelines propose that conservative management, such as rehabilitation interventions, should be prioritized for DRA. However, there is a lack of consensus among researchers regarding the most effective exercise regimen, resulting in diverse rehabilitation programs. Recent evidence advocates not only for closing the gap but also for achieving optimal function. Current studies often neglect to address functional rehabilitation, underscoring the necessity for robust clinical trials, which is the primary focus of this study. Additionally, although breathing exercises are commonly prescribed for DRA, the precise role of the diaphragm, the primary respiratory muscle, in rehabilitation hasn't been fully examined. The diaphragm forms the upper boundary of the abdominal cavity and plays a key role in the stability of the trunk, working together with the abdominal and pelvic floor muscles. A recent study found reduced diaphragm excursion in postpartum women with lumbopelvic pain during a low postural demanding task, while previous studies suggest that diaphragm training could alleviate such symptoms influencing factors such as diaphragm thickness and excursion, which may be linked to improved trunk stability. Hence, training the diaphragm and accessory inspiratory muscles through Inspiratory Muscle Training (IMT) could potentially play a crucial role in managing DRA. In summary, the goal of this study is to develop and assess a comprehensive rehabilitation program aimed at effectively reducing DRA and addressing associated dysfunctions. The program will integrate evidence-based rehabilitation interventions, such as trunk stabilization exercises and IMT, targeting all related dysfunctions caused by DRA, and introducing a novel therapeutic protocol not previously implemented. The study will take the form of a prospective, randomized controlled trial (RCT).

Conditions

Diastasis, Muscle; Diastasis Recti And Weakness Of The Linea Alba

Keywords

Rehabilitation Research; Telerehabilitation; Exercise Therapy; Breathing Exercise

Outcome Measures

Primary Outcomes (1)

• Inter-recti distance (IRD)

  Distance between the rectus muscles measured in cm via diagnostic ultrasound (Mota et al., 2018).

  IRD is measured at baseline, at 3 months and at 6 months (follow-up assessment).

Secondary Outcomes (12)

• Diaphragmatic Thickness

  Diaphragmatic Thickness is assessed at baseline, at 3 months and at 6 months from baseline (follow-up assessment).

• Diaphragmatic Excursion

  Diaphragmatic excursion is assessed at baseline, at 3 months and at 6 months from baseline (follow-up assessment).

• Maximum Inspiratory Pressure (MIP)

  MIP is assessed at baseline, at 3 months and at 6 months from baseline (follow-up assessment).

• Strength Index (S-Index)

  S-Index is assessed at baseline, at 3 months and at 6 months from baseline (follow-up assessment).

• Peak Inspiratory Flow (PIF)

  PIF is assessed at baseline, at 3 months and at 6 months from baseline (follow-up assessment).

Study Arms (3)

Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG)

EXPERIMENTAL

The Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG) will follow a comprehensive, 12-week therapeutic exercise program that involves progressive strengthening exercises specifically targeting the trunk and pelvic floor muscles, functional retraining exercises, and additional exercises focusing on strengthening the inspiratory muscles (Inspiratory Muscle Training - IMT).

Behavioral: Trunk exercise; Behavioral: Inspiratory Muscle Training (IMT)

Trunk Exercise Group (TEG)

ACTIVE COMPARATOR

The Trunk Exercise Group (TEG) will partake in a comprehensive 12-week therapeutic exercise program that involves progressive strengthening exercises specifically targeting the trunk and pelvic floor muscles, alongside functional retraining exercises.

Behavioral: Trunk exercise

Control group (CG)

ACTIVE COMPARATOR

The control group (CG) will receive general management information for DRA, and written instructions for engaging the deeper abdominals and pelvic floor muscles, accompanied by an educational exercise session. Participants will be encouraged to perform these contractions regularly, without guidance or supervision.

Behavioral: Control Group

Interventions

Trunk exercise BEHAVIORAL

Trunk stabilization exercises including the following components: (a) progressive deep abdominal muscle retraining (transversus abdominis), (b) progressive pelvic floor muscle retraining, (c) abdominal muscle strengthening exercises (rectus abdominis and obliques), (d) combination of abdominal muscle control and distal extremity movements, and (e) progressive functional exercises.

Trunk Exercise Group (TEG); Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG)

Inspiratory Muscle Training (IMT) BEHAVIORAL

Inspiratory muscle strengthening exercises using inspiratory resistance (IMT devices)

Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG)

Control Group BEHAVIORAL

Participants in the Control Group will receive general management information for DRA, written instructions and a single educational exercise session for contracting the deeper abdominals and pelvic floor muscles.

Control group (CG)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 18-50 years
• Diagnosed with diastasis recti abdominis (DRA) with an inter-recti distance (IRD) greater than 2.8 cm
• Beyond 6 months postpartum (preferably within the range of up to 5 years postpartum)

You may not qualify if:

• Severe chronic respiratory disease (i.e. COPD, chronic bronchitis, pulmonary emphysema or fibrosis)
• Connective tissue disorders
• Neurological disorders
• Severe musculoskeletal conditions hindering exercise participation (e.g., severe low back pain, sciatica, etc.)
• Previous abdominal surgeries (excluding cesarean section)
• Delivery within the last 6 months
• BMI greater than 30 kg/m²

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras

Pátrai, 26504, Greece

RECRUITING

Related Publications (39)

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MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba; Diastasis, Muscle

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Evdokia Billis, PhD

  University of Patras, Department of Physiotherapy

  STUDY DIRECTOR

Central Study Contacts

Anastasia Skoura, MSc

CONTACT

00306947784948; a.skoura@upatras.gr

Evdokia Billis, PhD

CONTACT

00306973047170; billis@upatras.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: In this interventional study, three distinct groups are included. The Trunk Exercise Group (TEG) will partake in a comprehensive 12-week therapeutic exercise program that involves progressive strengthening exercises specifically targeting the trunk and pelvic floor muscles, alongside functional retraining exercises. The Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG) will adhere to the same 12-week therapeutic exercise program as TEG, with additional exercises focusing on strengthening the inspiratory muscles using inspiratory resistance (IMT). The control group (CG) will not participate in the 12-week exercise program but will receive a single exercise session and general management information (oral and written) for DRA.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 29, 2024
• Study Start: March 11, 2024
• Primary Completion: August 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)