ClinicalTrials.gg
CompletedNCT07767357HPFT-LPFTUpdated Aug 17, 2026

Comparative Impact of Hydrotherapy and Land-Based Exercise on Pelvic Floor Muscle Endurance in Pregnant Women

An interventional study of Hydrotherapy-Based Pelvic Floor Muscle Training and Land Based Pelvic Floor Muscle Training in Pelvic Floor Disorders and Pregnancy, sponsored by Saveetha University. Completed at 1 site in India. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Saveetha University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Nov 2024, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
256
Allocation
Non-randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

The goal of this retrospective study is to compare the effects of hydrotherapy and land-based exercise on pelvic floor muscle endurance in pregnant women. The main question it aims to answer is whether pelvic floor muscle endurance differs between women who participated in hydrotherapy and those who participated in land-based exercise.

Researchers will compare existing clinical records of pregnant women who received hydrotherapy or land-based exercise. The study will examine pelvic floor muscle endurance measured using the Modified Oxford Grading (MOG) and other available pelvic floor assessments.

The study will use information already recorded during routine care. No new exercise program or treatment will be given as part of this retrospective study.

Read the detailed description

Pelvic floor muscles support the bladder, bowel, and reproductive organs and play an important role in maintaining pelvic floor function during pregnancy. Pregnancy can place increased demands on these muscles because of changes in body weight, posture, hormonal changes, and pressure on the pelvic floor.

Exercise during pregnancy may help maintain pelvic floor muscle function. Hydrotherapy provides exercise in water, where buoyancy can reduce the load on the body and may allow pregnant women to exercise with greater comfort. Land-based exercise is another commonly used approach for maintaining physical function during pregnancy. However, it is not clear whether hydrotherapy and land-based exercise are associated with different levels of pelvic floor muscle endurance.

This retrospective study will review existing clinical records of pregnant women who participated in hydrotherapy or land-based exercise. The researchers will compare the available pelvic floor muscle assessment findings between the two groups to determine whether pelvic floor muscle endurance differs between the exercise approaches.

The findings may provide information about the potential role of hydrotherapy and land-based exercise in maintaining pelvic floor muscle function during pregnancy. The results may also help physiotherapists make informed decisions when selecting exercise approaches for pregnant women.

02

Conditions studied

  • Pelvic Floor Disorders
  • Pregnancy

Keywords

  • Pregnancy
  • Pelvic floor muscle endurance
  • Hydrotherapy
  • Land-based exercise
  • Pelvic floor muscle training
03

In context

Pelvic Floor Disorders

212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.

This study's enrollment of 256 is above the median of 64 across 148 interventional studies indexed under Pelvic Floor Disorders.

Browse Pelvic Floor Disorders studies →

Lead sponsor

Saveetha University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • Pregnant women aged 20-35 years, singleton pregnancy confirmed by ultrasound, gestational age between 18 and 32 weeks (second to early third trimester), absence of obstetric complications such as placenta previa, gestational diabetes or preeclampsia medical clearance from an obstetrician to participate in hydrotherapy and moderate physical activity, ability to understand and follow instructions, willingness to participate in regular exercise sessions and attend follow-up assessments for 6 weeks.

Exclusion criteria

Exclusion Criteria:

  • Age below 20 years or above 35 years, gestational age outside the 18-32week range, multiple pregnancy, obstetric complications such as placenta previa, uncontrolled gestational diabetes or pregnancy-induced hypertension, open wounds or infections contraindicating hydrotherapy, musculoskeletal conditions limiting safe participation in aquatic exercise, history of cardiovascular or respiratory disorders, fear of water or discomfort in aquatic environments, inability to complete follow-up evaluations or refusal to participate in the intervention period.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
256 participants (actual)

Study arms

  • Experimental
    Hydrotherapy-Based Pelvic Floor Muscle Training

    Other: Hydrotherapy-Based Pelvic Floor Muscle Training

  • Active comparator
    Land-Based Pelvic Floor Muscle Training

    Other: Land Based Pelvic Floor Muscle Training

Interventions

  • OtherHydrotherapy-Based Pelvic Floor Muscle Training

    A structured hydrotherapy-based pelvic floor muscle training program conducted in a heated indoor therapy pool. Sessions were performed for 30 minutes, three times per week for six weeks, under the supervision of a trained physiotherapist. The water temperature was maintained at 32°C-34°C. Each session included warm-up and diaphragmatic breathing, pelvic floor muscle activation in supported buoyant positions, dynamic aquatic strengthening, and cool-down. Pelvic floor contractions were performed using the "squeeze and lift" technique, with three sets of 10 contractions held for five seconds. Aquatic exercises included water walking, hip movements, side leg raises, and supported squats using flotation devices or light aquatic equipment. Sessions concluded with stretching, relaxation, and breathing exercises.

  • OtherLand Based Pelvic Floor Muscle Training

    A structured land-based pelvic floor muscle training program conducted in a clinical exercise setting. Sessions were performed for 30 minutes, three times per week for six weeks, under the supervision of a trained physiotherapist. Each session included warm-up and diaphragmatic breathing, pelvic floor muscle activation, dynamic land-based strengthening, and cool-down. Pelvic floor contractions were performed using the "squeeze and lift" technique, with three sets of 10 contractions held for five seconds. Land-based exercises included walking, supported squats, hip movements, side leg raises, and functional strengthening exercises with controlled breathing and postural alignment. Sessions concluded with stretching, relaxation, and breathing exercises.

06

What researchers measure

Primary outcomes

  1. Change in Pelvic Floor Muscle Endurance measured using Perineometer

    Pelvic floor muscle endurance will be assessed using a perineometer, which measures the intravaginal pressure generated during voluntary pelvic floor muscle contractions. Participants will be instructed to perform sustained pelvic floor muscle contractions, and the pressure generated will be recorded in centimeters of water (cmH₂O). The perineometer provides an objective measure of pelvic floor muscle function and endurance. Measurements will be recorded at each assessment time point and analyzed as changes within and between the hydrotherapy-based pelvic floor muscle training and land-based pelvic floor muscle training groups.

    Time frame: Baseline (Week 0), Week 3, Week 6

Secondary outcomes

  1. Change in Pelvic Floor Muscle Strength measured using Modified Oxford Grading Scale

    Pelvic floor muscle strength will be assessed using the Modified Oxford Grading Scale through digital vaginal palpation. Muscle strength will be graded from 0 to 5, with 0 indicating no palpable contraction and 5 indicating a strong contraction against resistance. The MOGS score will be recorded at each assessment time point and analyzed to determine changes in pelvic floor muscle strength within and between the hydrotherapy-based pelvic floor muscle training and land-based pelvic floor muscle training groups.

    Time frame: Baseline (Week 0), Week 3, Week 6

  2. Change in Urinary Incontinence Severity measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

    Urinary incontinence severity will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The questionnaire assesses the frequency and severity of urinary leakage and its impact on everyday life. The total score will be recorded at each assessment time point, with higher scores indicating greater severity and impact of urinary incontinence. Changes in scores will be analyzed within and between the hydrotherapy-based pelvic floor muscle training and land-based pelvic floor muscle training groups.

    Time frame: Baseline (Week 0), Week 3, Week 6

07

Study locations

1 site
  • Saveetha Medical College and Hospital (SMCH)
    Chennai, Tamil Nadu 602105, India
08

References and documents

Publications

  • Kahyaoglu Sut H, Balkanli Kaplan P. Effect of pelvic floor muscle exercise on pelvic floor muscle activity and voiding functions during pregnancy and the postpartum period. Neurourol Urodyn. 2016 Mar;35(3):417-22. doi: 10.1002/nau.22728. Epub 2015 Feb 3. PubMed 25648223 ↗
  • Rodriguez-Blanque R, Sanchez-Garcia JC, Sanchez-Lopez AM, Exposito-Ruiz M, Aguilar-Cordero MJ. Randomized Clinical Trial of an Aquatic Physical Exercise Program During Pregnancy. J Obstet Gynecol Neonatal Nurs. 2019 May;48(3):321-331. doi: 10.1016/j.jogn.2019.02.003. Epub 2019 Apr 4. PubMed 30953605 ↗
  • Sigurdardottir T, Steingrimsdottir T, Arnason A, Bo K. Pelvic floor muscle function before and after first childbirth. Int Urogynecol J. 2011 Dec;22(12):1497-503. doi: 10.1007/s00192-011-1518-9. Epub 2011 Jul 26. PubMed 21789656 ↗
  • Muro S, Akita K. Pelvic floor and perineal muscles: a dynamic coordination between skeletal and smooth muscles on pelvic floor stabilization. Anat Sci Int. 2023 Jul;98(3):407-425. doi: 10.1007/s12565-023-00717-7. Epub 2023 Mar 24. PubMed 36961619 ↗
  • Vallim AL, Osis MJ, Cecatti JG, Baciuk EP, Silveira C, Cavalcante SR. Water exercises and quality of life during pregnancy. Reprod Health. 2011 May 16;8:14. doi: 10.1186/1742-4755-8-14. PubMed 21575243 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2024 to primary completion in Jul 2025, 8 months.

Of 101 non-industry interventional studies with no phase under Pelvic Floor Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's 8 months is below that.

Counting every sponsor, half of 107 studies reached it within 17 months; a quarter within 7 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 17, 2026
StartActual
Nov 1, 2024
Primary completionActual
Jul 25, 2025
CompletionActual
Apr 22, 2026
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07767357
Lead sponsor
Saveetha University
Responsible party
Pavithra Sakthivel (Principal Investigator, Saveetha University) — Principal investigator
First posted
Aug 17, 2026
Start date
Nov 1, 2024
Primary completion
Jul 25, 2025
Completion
Apr 22, 2026
Last update
Aug 17, 2026

Study contacts

Shenbaga Sundaram Subramanian
study director · Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS)

Oversight

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

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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