Pelvic Floor Muscle DysfunctionRESTORE-PFNCT07478627
Comparison of Rehabilitation Exercise Protocol (5R) and Swiss Ball Training for Postpartum Pelvic Floor Muscle Dysfunction
A study testing Rehabilitation Exercise Protocol (5R) and Swiss Ball Training in people with Pelvic Floor Muscle Dysfunction, run by Rafia Abrar at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pelvic Floor Muscle Dysfunction
- What is being tested?
- Rehabilitation Exercise Protocol (5R) and Swiss Ball Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Mar 2026to 25 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
University of Lahore Teaching Hospital, Lahore
Lahore, Punjab Province, 54000
Rafia Abrar, MSPTW, 03066264413, rafiaabrar345@gmail.com
Montiha Azeem, MSPTN, 03479717317, muntahaazeem9@gmail.com
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pelvic Floor Muscle Dysfunction
- Being tested
- Rehabilitation Exercise Protocol (5R), Swiss Ball Training
- Keywords
- Postpartum Rehabilitation, Pelvic Floor Muscle Training, Swiss Ball Training, 5R Rehabilitation Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Exercise Protocol (5R)Behavioural
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.
Swiss Ball TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| group A Rehabilitation Exercise Protocol (5R) | Experimental | 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. Receives: Behavioral: Rehabilitation Exercise Protocol (5R) |
| group B Swiss Ball Training | Active comparator | 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. Receives: Behavioral: Swiss Ball Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Muscle Strength
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.
Measured: Baseline, 4 weeks and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion23 Apr 2026 (estimated)
- Study completion25 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rafia Abrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafia Abrar, University of Lahore
- Investigators
- Rafia Abrar, MSPTW, Principal investigator, The University of Lahore, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478627
- Sponsor's protocol ID
- UOL/IREB/25/15/03/44
- Acronym
- RESTORE-PF
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rehabilitation Exercise Protocol (5R) and Swiss Ball Training for Postpartum Pelvic Floor Muscle Dysfunction
- ClinicalTrials.gov ID
- NCT07478627
- Acronym / sponsor ID
- RESTORE-PF / UOL/IREB/25/15/03/44
- Conditions
- Pelvic Floor Muscle Dysfunction
- Keywords
- Postpartum Rehabilitation, Pelvic Floor Muscle Training, Swiss Ball Training, 5R Rehabilitation Protocol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Rafia AbrarUniversity, hospital or other
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 23 Apr 2026 (estimated)
- Study completion
- 25 Apr 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A Rehabilitation Exercise Protocol (5R) | Experimental | Behavioral: 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. |
| group B Swiss Ball Training | Active comparator | Behavioral: Swiss Ball TrainingParticipants 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | group A Rehabilitation Exercise Protocol (5R) |
| Swiss Ball TrainingSwiss 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. | Behavioural | group B Swiss Ball Training |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Related trials for Pelvic Floor Muscle Dysfunction
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafia Abrar, MSPTW principal investigator
The University of Lahore, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Exercise Protocol (5R) and Swiss Ball Training in people with Pelvic Floor Muscle Dysfunction, run by Rafia Abrar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafia Abrar, MSPTW (03066462413, rafiaabrar345@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Muscle Strength (time frame: Baseline, 4 weeks and after 8 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.