ClinicalTrials.gg
RecruitingNCT07440875Updated Feb 27, 2026

Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises

An interventional study of hypopressive excercises and pelvic training excercises in Pelvic Organ Prolapse, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Aug 2025, registered Feb 2026).
  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study summary

Pelvic Organ Prolapse (POP) is a prevalent condition affecting women's quality of life due to the descent of pelvic organs caused by weak pelvic floor muscles (PFMs). This randomized controlled trial aims to compare the effects of pelvic floor muscle training (PFMT) alone and PFMT combined with hypopressive exercises in improving pelvic floor muscle strength, reducing dyspareunia, and enhancing overall quality of life in women aged 45-65 diagnosed with stage I-II POP.This study will be randomized controlled trial and will be conducted in Qasim Sandhu Hospital, Muhammadi Medical Trust and Clinic 1. This will undergo 4 sessions totaling 1 month of treatment. . Non-probability convenience sampling technique will be used and 46 participants will be recruited in study after randomization.The subjects will be divided into two groups. Group A will receive pelvic floor muscle training with hypopressive exercises and Group B will receive pelvic floor muscle training without hypopressive exercises receiving baseline treatment.

Read the 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

02

Conditions studied

  • Pelvic Organ Prolapse

Keywords

  • Female
  • Pelvic Floor
  • Quality of Life
  • Dyspareunia
  • Exercise
  • Pelvic Organ Prolapse
03

In context

Pelvic Organ Prolapse

521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.

This study's planned enrollment of 51 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.

Browse Pelvic Organ Prolapse studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Married women
  • Age 45-65 years
  • Post menopausal
  • uterine prolapse
  • Stage I \& II

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • 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

    Other: hypopressive excercises · Other: pelvic training excercises

  • 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.

    Other: pelvic training excercises

Interventions

  • Otherhypopressive excercises

    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.

  • Otherpelvic training excercises

    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.

06

What researchers measure

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS) for assessment of pain

    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.

    Time frame: 4 week

  2. Modified Oxford Scale for assessment of muscle strength

    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

    Time frame: 4 weeks

  3. PFIQ7 for assessment of quality of life

    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)

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Qasim Sandhu Hospital
    Lahore, Punjab Province 6400, Pakistan
    Recruiting
08

References and documents

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. PubMed 35312800 ↗
  • 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. PubMed 37464172 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07440875
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Aug 1, 2025
Primary completion
Apr 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

imran amjad, PhD
Contact
imran.amjad@riphah.edu.pk
03324390125
MEHAR UN NISA, MS
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion