- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440875
Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises
Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises On Strength, Dyspareunia and Quality Of Life in Pelvic Organ Prolapse
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
he study will utilize tools such as the Oxford Grading Scale for muscle strength, the Numeric Pain Rating Scale (VAS) for pain, and the Pelvic Floor Impact Questionnaire (PFIQ-7) for quality of life assessment.Data will be analyzed by using Statistical Package for Social Science SPSS version 25 software to get results of treatment strategies. Statistical significance will be set at P = 0.05.Use of statistical tests will be decided after normality tests.In parametric, independence t-test and paired t-test will be used. In non-parametric, Man-Whitney test will be used.
The purpose of this study is to provide effective data on whether the combination of PFMT and hypopressive exercises offers improvements in pelvic floor strength, dyspareunia, and enhances the quality of life compared to PFMT alone.
Key Words Female,Pelvic Floor, Quality of Life, Dyspareunia, Exercise, Therapy Pelvic Organ Prolapse
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
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Punjab Province
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Lahore, Punjab Province, Pakistan, 6400
- Recruiting
- Qasim Sandhu Hospital
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Contact:
- mehar un nisa UN NISA, MS
- Phone Number: 03344563221
- Email: meharun.nisa@riphah.edu.pk
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Principal Investigator:
- saweba irfan, MSPT-WH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Married women
- Age 45-65 years
- Post menopausal
- uterine prolapse
- Stage I & II
Exclusion Criteria:
- Pregnancy or Postpartum (within last 6 months)
- History of Pelvic floor surgery e.g.hysterectomy
- Pts with other comorbidities e.g. neuromuscluar disease
- Participating in other pelvic floor muscle program.e.g. pilates , yoga, Psychiatric disorders effecting compliance.e.g. schizopherenia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: hyopressive excercises
The standardised intervention given to women in the PFMT group consisted of five appointments over a 4 weeks period .
At the first appointment, a standardised history was taken, and both a subjective prolapse assessment and internal pelvic floor muscle assessment (using the Power Endurance Repetitions Fast Every Contraction Timed (PERFECT) scheme, including the modified Oxford scale were carried out.Women were also taught how to correctly contract the pelvic floor muscles and how to pre-contract the pelvic floor muscles individualized home exercise programme was prescribed, and women were encouraged to perform six sets of exercises daily with the use of an exercise diary to record compliance.
A standardized lifestyle advice sheet was given to women containing all essential instructions
|
The initial maneuver involved sustaining apnea with rib-cage expansion for approximately 10 seconds in supine, standing, and sitting positions. Participants progressed through hypopressive postures including standing, kneeling, four-point kneeling, sitting, and supine, with varied limb positions. Each hypopressive exercise consisted of 3 repetitions per posture, with a rest breath between repetitions. Sessions included 5-10 hypopressive exercises based on participant skill and readiness, with each exercise repeated three times per session. No voluntary contraction of pelvic floor or abdominal muscles was permitted during performance. Week 1: Foundational breathing and supine hypopressive exercises performed 3×/week for 15-20 minutes to establish basic apnea control and postural awareness. Week 2: Progression to seated and standing poses 4×/week for 20-25 minutes, increasing hold time and postural endurance. Week 3: Advanced kneeling and squat-based hypopressive activation 4-5×/week for 25-30 minutes to integrate functional core control. Week 4: Mastery phase with full squat, walking, and combination poses 5×/week for 30-35 minutes to enhance dynamic postural stability. |
|
Active Comparator: pelvic training excercise
Week 1: Foundational breathing and supine hypopressive exercises performed 3×/week for 15-20 minutes to establish basic apnea control and postural awareness. Week 2: Progression to seated and standing poses 4×/week for 20-25 minutes, increasing hold time and postural endurance. Week 3: Advanced kneeling and squat-based hypopressive activation 4-5×/week for 25-30 minutes to integrate functional core control. Week 4: Mastery phase with full squat, walking, and combination poses 5×/week for 30-35 minutes to enhance dynamic postural stability. |
Week 1: Foundational breathing and supine hypopressive exercises performed 3×/week for 15-20 minutes to establish basic apnea control and postural awareness. Week 2: Progression to seated and standing poses 4×/week for 20-25 minutes, increasing hold time and postural endurance. Week 3: Advanced kneeling and squat-based hypopressive activation 4-5×/week for 25-30 minutes to integrate functional core control. Week 4: Mastery phase with full squat, walking, and combination poses 5×/week for 30-35 minutes to enhance dynamic postural stability. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) for assessment of pain
Time Frame: 4 week
|
the test-retest reliability for the NPRS has been demonstrated to be moderate to high, varying from 0.67 to 0.96.
Criterion validity has not been established for the NPRS as there are no 'gold standards' for pain measurement; however, when correlated with the VAS, the NPRS is determined to have 0.79 to 0.95 convergent validity.
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4 week
|
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Modified Oxford Scale for assessment of muscle strength
Time Frame: 4 weeks
|
The modified Oxford scale is a practical tool for use in clinical studies and can provide an adequate measure of PFM strength, provided a study is sufficiently powered.
The Icc value r=0.97 and Cronbach @ is 0.845.
The scale demonstrates high intra-rater reliability, meaning that the same clinician tends to produce consistent results when re-assessing the same patient
|
4 weeks
|
|
PFIQ7 for assessment of quality of life
Time Frame: 4 weeks
|
Pelvic Floor Impact Questionnaire-7 is valid, reliable, and responsive short forms of condition-specific quality-of-life questionnaires for women with pelvic floor disorders.Construct validity of the tool demonstrated by many fold higher scores among patients with POP compared with women without POP (p<0.0001)
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4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MEHAR UN NISA, MS, Riphah International University
Publications and helpful links
General Publications
- Feigenbaum T. Physical Therapy in the Treatment and Prevention of Pelvic Floor Dysfunctions in Women. The Science Journal of the Lander College of Arts and Sciences. 2022;16(1)
- Boraschi Gomes V, Fernandes Torres T, Merino D, Castiglione M, Pavione Rodrigues Pereira R, Tanaka C. (PM-05) EFFICACY OF PELVIC FLOOR MUSCLE TRAINING AND PERINEAL MASSAGE IN THE TREATMENT OF WOMEN WITH DYSPAREUNIA: NARRATIVE REVIEW OF THE LITERATURE. The Journal of Sexual Medicine. 2024;21
- Wang T, Wen Z, Li M. The effect of pelvic floor muscle training for women with pelvic organ prolapse: a meta-analysis. Int Urogynecol J. 2022 Jul;33(7):1789-1801. doi: 10.1007/s00192-022-05139-z. Epub 2022 Mar 21.
- Guan Y, Han J. Quality-of-life improvements in patients after various surgical treatments for pelvic organ prolapse. Arch Gynecol Obstet. 2024 Mar;309(3):813-820. doi: 10.1007/s00404-023-07140-3. Epub 2023 Jul 19.
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Genital Diseases, Male
- Male Urogenital Diseases
- Pathological Conditions, Anatomical
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Sexual Dysfunction, Physiological
- Sexual Dysfunctions, Psychological
- Prolapse
- Pathological Conditions, Signs and Symptoms
- Behavior
- Pelvic Organ Prolapse
- Dyspareunia
- Motor Activity
Other Study ID Numbers
- REC/RCR&AHS/24/0541
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
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.
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