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

Rafia Abrar

Status: Enrolling

Conditions: Pelvic Floor Muscle Dysfunction

Treatments: Behavioral: Rehabilitation Exercise Protocol (5R); Behavioral: Swiss Ball Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07478627

UOL/IREB/25/15/03/44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

group A Rehabilitation Exercise Protocol (5R)

Experimental group

Description:

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.

Treatment:

Behavioral: Rehabilitation Exercise Protocol (5R)

group B Swiss Ball Training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Swiss Ball Training