Pelvic Floor DisordersHPFT-LPFTNCT07767357
Comparative Impact of Hydrotherapy and Land-Based Exercise on Pelvic Floor Muscle Endurance in Pregnant Women
A study testing Hydrotherapy-Based Pelvic Floor Muscle Training and Land Based Pelvic Floor Muscle Training in people with Pelvic Floor Disorders and Pregnancy, run by Saveetha University at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pelvic Floor Disorders, Pregnancy
- What is being tested?
- Hydrotherapy-Based Pelvic Floor Muscle Training and Land Based Pelvic Floor Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2024to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Saveetha Medical College and Hospital (SMCH)
Chennai, Tamil Nadu, 602105
About this study
Official title: Comparative Effectiveness of Hydrotherapy and Land-Based Exercise on Pelvic Floor Muscle Endurance in Pregnant Women: A Retrospective Comparative Study
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.
- Conditions
- Pelvic Floor Disorders, Pregnancy
- Being tested
- Hydrotherapy-Based Pelvic Floor Muscle Training, Land Based Pelvic Floor Muscle Training
- Keywords
- Pregnancy, Pelvic floor muscle endurance, Hydrotherapy, Land-based exercise, Pelvic floor muscle training
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrotherapy-Based Pelvic Floor Muscle TrainingOther
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.
Land Based Pelvic Floor Muscle TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydrotherapy-Based Pelvic Floor Muscle Training | Experimental | Not described Receives: Other: Hydrotherapy-Based Pelvic Floor Muscle Training |
| Land-Based Pelvic Floor Muscle Training | Active comparator | Not described Receives: Other: Land Based Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Week 3, Week 6
Secondary outcomes (2)
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.
Measured: Baseline (Week 0), Week 3, Week 6
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.
Measured: Baseline (Week 0), Week 3, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Nov 2024
- Primary completion25 Jul 2025
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saveetha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavithra Sakthivel, Saveetha University
- Investigators
- Shenbaga Sundaram Subramanian, Study director, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767357
- Sponsor's protocol ID
- 010/05/2024/ISRB/FGSR/SCPT
- Acronym
- HPFT-LPFT
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25648223Rodriguez-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 30953605Sigurdardottir 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 21789656Muro 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 36961619Vallim 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 at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Hydrotherapy and Land-Based Exercise on Pelvic Floor Muscle Endurance in Pregnant Women: A Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT07767357
- Acronym / sponsor ID
- HPFT-LPFT / 010/05/2024/ISRB/FGSR/SCPT
- Conditions
- Pelvic Floor Disorders, Pregnancy
- Keywords
- Pregnancy, Pelvic floor muscle endurance, Hydrotherapy, Land-based exercise, Pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Saveetha UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrotherapy-Based Pelvic Floor Muscle Training | Experimental | Other: Hydrotherapy-Based Pelvic Floor Muscle Training |
| Land-Based Pelvic Floor Muscle Training | Active comparator | Other: Land Based Pelvic Floor Muscle Training |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrotherapy-Based Pelvic Floor Muscle TrainingA 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. | Other | Hydrotherapy-Based Pelvic Floor Muscle Training |
| Land Based Pelvic Floor Muscle TrainingA 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. | Other | Land-Based Pelvic Floor Muscle Training |
Primary outcome
Change in Pelvic Floor Muscle Endurance measured using Perineometer
Time frame: Baseline (Week 0), Week 3, Week 6
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.
2 secondary outcomes
Change in Pelvic Floor Muscle Strength measured using Modified Oxford Grading Scale
Time frame: Baseline (Week 0), Week 3, Week 6
Change in Urinary Incontinence Severity measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time frame: Baseline (Week 0), Week 3, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 25648223Kahyaoglu 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.
- Background: PubMed 30953605Rodriguez-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.
- Background: PubMed 21789656Sigurdardottir 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.
- Background: PubMed 36961619Muro 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.
- Results publication: PubMed 21575243Vallim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenbaga Sundaram Subramanian study director
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrotherapy-Based Pelvic Floor Muscle Training and Land Based Pelvic Floor Muscle Training in people with Pelvic Floor Disorders and Pregnancy, run by Saveetha University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pelvic Floor Muscle Endurance measured using Perineometer (time frame: Baseline (Week 0), Week 3, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07767357, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.