Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises

NCT07440875 | Recruiting

• 1 other identifier: REC/RCR&AHS/24/0541
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Organ Prolapse

Keywords

Female; Pelvic Floor; Quality of Life; Dyspareunia; Exercise; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (3)

• 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.

  4 week

• 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

  4 weeks

• 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)

  4 weeks

Study Arms (2)

hyopressive excercises

EXPERIMENTAL

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

pelvic training excercise

ACTIVE COMPARATOR

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

pelvic training excercises OTHER

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.

hyopressive excercises; pelvic training excercise

hypopressive excercises OTHER

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.

hyopressive excercises

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: pelvic organ prolapse is common in females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Qasim Sandhu Hospital

Lahore, Punjab Province, 6400, Pakistan

RECRUITING

Related Publications (4)

• 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)

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35312800 BACKGROUND

• 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.

  PMID: 37464172 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Dyspareunia; Motor Activity

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Behavior

Study Officials

• MEHAR UN NISA, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)