Comparison of Rehabilitation Exercise Protocol (5R) and Swiss Ball Training for Postpartum Pelvic Floor Muscle Dysfunction (RESTORE-PF)

March 12, 2026 updated by: Rafia Abrar

Postpartum pelvic floor muscle dysfunction is a common condition affecting many women after childbirth. Weakness or impairment of the pelvic floor muscles can lead to symptoms such as urinary incontinence, pelvic discomfort, and reduced quality of life. Rehabilitation exercises targeting pelvic floor muscles are widely used to restore muscle strength and improve functional outcomes.

The purpose of this study is to compare the effectiveness of a structured Rehabilitation Exercise Protocol (5R) with Swiss ball training in improving pelvic floor muscle function among postpartum women diagnosed with pelvic floor muscle dysfunction. The 5R protocol focuses on progressive rehabilitation strategies including relaxation, recruitment, resistance, repetition, and recovery of pelvic floor muscles. Swiss ball training involves exercises performed on a stability ball that aim to enhance core stability, pelvic control, and muscular coordination.

Eligible postpartum women with pelvic floor muscle dysfunction will be randomly assigned to one of two groups. One group will receive the structured 5R rehabilitation exercise protocol, while the other group will participate in Swiss ball training exercises. Both interventions will be performed for a specified duration under the supervision of trained physiotherapists.

Outcome measures will assess pelvic floor muscle strength, functional improvement, and symptom severity before and after the intervention period. The findings of this study may help determine the most effective rehabilitation strategy for improving pelvic floor muscle function and promoting recovery in postpartum women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postpartum pelvic floor muscle dysfunction (PFMD) is a significant health concern affecting women after childbirth. Pregnancy and vaginal delivery can lead to stretching, weakening, and potential injury to the pelvic floor muscles and connective tissues. As a result, many postpartum women experience symptoms such as urinary incontinence, pelvic organ prolapse, decreased pelvic stability, and reduced functional capacity. These symptoms can significantly affect daily activities, psychological well-being, and overall quality of life.

Physiotherapy-based rehabilitation is considered one of the most effective non-invasive management strategies for postpartum pelvic floor dysfunction. Various exercise-based approaches have been proposed to strengthen pelvic floor muscles, improve neuromuscular control, and restore functional stability of the pelvic region.

The Rehabilitation Exercise Protocol (5R) is a structured therapeutic program designed to promote systematic recovery of pelvic floor muscle function. The protocol typically incorporates progressive phases including muscle relaxation, activation and recruitment of pelvic floor muscles, resistance training, repeated contractions for endurance, and recovery strategies to enhance muscle performance and functional stability.

Swiss ball training has also gained popularity as a rehabilitation method for postpartum women. Exercises performed on a Swiss ball introduce an element of instability, which stimulates activation of the core musculature including the pelvic floor, abdominal muscles, and lower back stabilizers. This training approach may improve coordination, balance, and pelvic stability while enhancing overall muscle strength.

Despite the widespread use of both approaches, limited evidence exists comparing the effectiveness of the structured 5R rehabilitation protocol and Swiss ball training in postpartum pelvic floor rehabilitation. Therefore, this study aims to compare the therapeutic effects of these two interventions in postpartum women diagnosed with pelvic floor muscle dysfunction.

This randomized controlled study will recruit postpartum women who meet the eligibility criteria. Participants will be randomly allocated into two groups. Group A will receive the Rehabilitation Exercise Protocol (5R), while Group B will undergo Swiss ball training exercises. Both interventions will be conducted over a defined treatment period under physiotherapy supervision.

Outcome measures will be assessed at baseline and after completion of the intervention period to evaluate improvements in pelvic floor muscle strength, symptom severity, and functional outcomes. The results of this study will provide evidence regarding the most effective physiotherapy intervention for postpartum pelvic floor muscle rehabilitation and may guide clinical practice for improving postpartum recovery.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • University of Lahore Teaching Hospital, Lahore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafia Abrar, MSPTW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Females aged 20-40 years who have given birth within the last 6 months (normal deliveries).

Delivery mood: both Normal and cesarean deliveries. Primiparous and Multiparous women. Women willing to participate in study. Confirmed pelvic floor dysfunction. Self-report of urinary incontinence (stress or urge) occurring at least once per week

Exclusion Criteria:

Women with high-risk pregnancies or postpartum complications (e.g., severe preeclampsia, postpartum hemorrhage).

Participants with diagnosed musculoskeletal or neurological disorders affecting movement.

History of pelvic surgery or severe musculoskeletal disorders. Women with diastasis recti exceeding a clinically significant threshold

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A Rehabilitation Exercise Protocol (5R)
Participants in this group will receive the Rehabilitation Exercise Protocol (5R), a structured physiotherapy program designed to improve pelvic floor muscle strength and function in postpartum women. The protocol includes progressive phases focusing on relaxation, recruitment and activation of pelvic floor muscles, resistance-based strengthening, repeated contractions to improve endurance, and recovery strategies. Exercises will be supervised by a physiotherapist and performed according to the study treatment schedule throughout the intervention period.
Behavioral: Rehabilitation Exercise Protocol (5R)
The Rehabilitation Exercise Protocol (5R) is a structured physiotherapy-based program designed to improve pelvic floor muscle strength and function in postpartum women. The protocol consists of progressive rehabilitation phases including relaxation of pelvic floor muscles, recruitment and activation exercises, resistance-based strengthening, repeated contractions to improve endurance, and recovery strategies. Participants will perform supervised pelvic floor exercises guided by a physiotherapist according to a structured treatment schedule throughout the intervention period.
Active Comparator: group B Swiss Ball Training
Participants in this group will undergo Swiss ball training exercises aimed at improving pelvic floor muscle function, core stability, and pelvic control. The intervention includes exercises performed on a stability ball to activate pelvic floor muscles along with abdominal and trunk stabilizers. The exercises will be conducted under the supervision of a physiotherapist and will follow a structured program throughout the intervention period.
Behavioral: Swiss Ball Training
Swiss ball training consists of a series of therapeutic exercises performed on a stability ball to improve pelvic floor muscle strength, core stability, and neuromuscular coordination in postpartum women. The exercises involve controlled pelvic tilts, bridging, seated balance exercises, and core activation movements that facilitate co-contraction of pelvic floor and abdominal muscles. The training program will be supervised by a physiotherapist and conducted according to the study protocol during the intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Muscle Strength
Time Frame: Baseline, 4 weeks and after 8 weeks of intervention
Pelvic floor muscle strength will be assessed using a standardized pelvic floor muscle assessment scale (such as the Modified Oxford Scale or perineometer measurement). The assessment will evaluate the strength and voluntary contraction of pelvic floor muscles in postpartum women with pelvic floor muscle dysfunction. Improvement in muscle strength will be compared between participants receiving the Rehabilitation Exercise Protocol (5R) and those undergoing Swiss ball training.
Baseline, 4 weeks and after 8 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rafia Abrar

Investigators

  • Principal Investigator: Rafia Abrar, MSPTW, The University of Lahore, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 23, 2026

Primary Completion (Estimated)

April 23, 2026

Study Completion (Estimated)

April 25, 2026

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UOL/IREB/25/15/03/44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pelvic Floor Muscle Dysfunction

Clinical Trials on Rehabilitation Exercise Protocol (5R)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe