- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521085
Combined Effects Of Stability Oriented Breathing Exercises and Kegel's Exercises in Postpartum Women
Combined Effects Of Stability Oriented Breathing Exercises and Kegel's Exercises On Inter-recti Distance, Lumbopelvic Pain and Strength In Postpartum Women
The postpartum period often presents challenges such as increased inter-recti distance (diastasis recti), lumbopelvic pain, and reduced core strength. This study is designed as a randomized controlled trial to evaluate the combined effects of stability-oriented breathing exercises and Kegel exercises on inter-recti distance (IRD), lumbopelvic pain, and muscle strength in postpartum women. A total sample size of 66 participants per group was determined with a 10% dropout rate accounted for.
The study will use a non-probability convenience sampling technique. It will be conducted at the University of Lahore Teaching Hospital and Sehat Medical complex. Inclusion criteria include women aged 18-40 years, with a history of cesarean sections, an IRD between 3-5 cm. Outcome measures include IRD , pelvic floor muscle strength, lumbopelvic pain (measured using a 10 cm numeric pain scale). Participants will be randomly assigned to either Group A (Kegel-only) or Group B (Kegel + breathing exercises). Both groups will train three times weekly for eight weeks. All data analysis will be performed using SPSS version 27.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The postpartum period often presents challenges such as increased inter-recti distance (diastasis recti), lumbopelvic pain, and reduced core strength. This study is designed as a randomized controlled trial to evaluate the combined effects of stability-oriented breathing exercises and Kegel exercises on inter-recti distance (IRD), lumbopelvic pain, and muscle strength in postpartum women. A total sample size of 66 participants per group was determined with a 10% dropout rate accounted for.
The study will use a non-probability convenience sampling technique. It will be conducted at the University of Lahore Teaching Hospital and Sehat Medical complex. Inclusion criteria include women aged 18-40 years, with a history of cesarean sections, an IRD between 3-5 cm. Outcome measures include IRD , pelvic floor muscle strength, lumbopelvic pain (measured using a 10 cm numeric pain scale). Participants will be randomly assigned to either Group A (Kegel-only) or Group B (Kegel + breathing exercises). Both groups will train three times weekly for eight weeks. All data analysis will be performed using SPSS version 27.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- UOL teaching hospital and sehat medical complex lahore
-
Contact:
- Masooma Saleem
- Phone Number: 03320711342
- Email: masooma.saleem@riphah.edu.pk
-
Principal Investigator:
- Areeba saleem butt, MSPT WH
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- UOL teaching hospital and sehat medical complex
-
Principal Investigator:
- Areeba saleem butt, MSPT WH
-
Contact:
- Masooma Saleem, MSWHPT
- Phone Number: 03320711342
- Email: masooma.saleem@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Age between 18-40 years
- Postpartum duration of 42-49 days
- Inter-recti distance (IRD) between 3-5 cm
- Numeric pain scale score ≤ 6 for pain
- No prior physiotherapy or exercise guidance received
Exclusion Criteria:
• Pain during the training period
- Patients with any heart or respiratory disease including excessive coughing and sneezing
- Patients with any kind of pelvic or abdominal surgery
- Significant organ dysfunction or psychiatric illness
- Diagnosis of malignant tumors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stability oriented Breathing training
This group will be given combined Kegel exercises and stability-oriented breathing training group with in postpartum women.
This included static breathing exercises (transverse, diaphragmatic, back, and pumping breathing) in the first two weeks, followed by resistance band breathing exercises targeting core and transversus abdominis activation in weeks 3 to 4. In the final four weeks, dynamic breathing exercises such as the pelvic clock and hundreds prep will be introduced to promote core stabilization under movement.
|
This included static breathing exercises (transverse, diaphragmatic, back, and pumping breathing) in the first two weeks, followed by resistance band breathing exercises targeting core and transversus abdominis activation in weeks 3 to 4. In the final four weeks, dynamic breathing exercises such as the pelvic clock and hundreds prep will be introduced to promote core stabilization under movement
|
|
Active Comparator: kegels exercises
This group will be given kegel exercises in postpartum women.
Sessions included a 10-minute warm-up of light jogging, walking, and stretching, followed by Kegel exercises starting with 10 repetitions per movement in the first two weeks and progressing to 15 repetitions in the following two weeks.
In the later weeks, load was progressively increased by extending the duration of contractions (from 5 to 8 seconds) and adding dynamic limb movements.
A 3-minute rest was provided between each set, and sessions concluded with a 5-minute cool-down
|
This group will be given kegel exercises in postpartum women.
Sessions included a 10-minute warm-up of light jogging, walking, and stretching, followed by Kegel exercises starting with 10 repetitions per movement in the first two weeks and progressing to 15 repetitions in the following two weeks.
In the later weeks, load was progressively increased by extending the duration of contractions (from 5 to 8 seconds) and adding dynamic limb movements.
A 3-minute rest was provided between each set, and sessions concluded with a 5-minute cool-down
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale
Time Frame: 8 weeks
|
This is the scale having that measures levels of pain from 0 to 11 it describes the intensity or severity of the pian
|
8 weeks
|
|
Manual muscle testing
Time Frame: 8 weeks
|
Pelvic floor muscle strength will be evaluated using a manual assessment technique.
During the assessment, the participant will be instructed to lie in a supine position with knees bent and hands resting at their sides.
Manual Muscle Testing (MMT) is a widely used, valid, and reliable method for assessing muscle strength through graded resistance applied by the examiner
|
8 weeks
|
|
Finger width method
Time Frame: 8 weeks
|
The measurement of diastasis recti abdominis width at the umbilicus using calipers demonstrated good reliability, with an intraclass correlation coefficient (ICC) of 0.83 (95% CI: 0.76 to 0.87).
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Masooma Saleem, MSPT WH, Riphah International University
Publications and helpful links
General Publications
- 1. Vesting S, Olsen MF, Gutke A, Rembeck G, Larsson ME. Clinical assessment of pelvic floor and abdominal muscles 3 months post partum: An inter-rater reliability study. BMJ Open. 2021;11(9):e049082.
- 2. Yalfani A, Bigdeli N, Gandomi F, Anvari Ali Abad R. [Proprioception and control of the lumbopelvic in women with and without diastasis rectus and their relationship with postpartum pain and disability (Persian)]. Scientific Journal of Rehabilitation Medicine. 2020;9(4):257-67.
- 3. Kaufmann R, Reiner C, Dietz U, Clavien P, Vonlanthen R, Käser S. Normal width of the linea alba, prevalence, and risk factors for diastasis recti abdominis in adults: a cross-sectional study. Hernia. 2022;26:609-18.
- 4. Tuominen R, Jahkola T, Saisto T, Arokoski J, Vironen J. The prevalence and consequences of abdominal rectus muscle diastasis among Finnish women: An epidemiological cohort study. Hernia. 2022;26(2):599-608.
- 5. Yalfani A, Bigdeli N, Gandomi F. [The effect of isometric-isotonic exercises of core stability in women with postpartum diastasis recti and its secondary disorders (randomized controlled clinical trial) (Persian)]. Journal of Health and Care. 2020;22(2):123-37.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR&AHS/25/0516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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