Pelvic FloorNCT07848451
Physiotherapy Exercise Programme for Pelvic Floor Function in Healthy Young Women
A study testing Multimodal Physiotherapy Exercise Programme in people with Pelvic Floor, run by Universidad Miguel Hernandez de Elche.
Trial summary
This study evaluated the effects of a 12-week physiotherapy exercise programme on pelvic floor and abdominopelvic function in healthy young nulliparous women. Participants were randomly allocated to an intervention group or a control group. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor
- What is being tested?
- Multimodal Physiotherapy Exercise Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to May 2017
- 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 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female university students aged 18 to 26 years.
- Nulliparous.
- No gynecological pathology.
- No respiratory pathology.
- History of sexual intercourse.
Who cannot join
- Failure to meet any of the inclusion criteria.
About this study
Official title: A Physiotherapy Exercise Programme Based on Hypopressive Exercise as Adjunctive Muscle Training for the Primary Prevention of Pelvic Floor Dysfunction
This study evaluated the effects of a 12-week physiotherapy exercise programme on pelvic floor and abdominopelvic function in healthy young nulliparous women. Participants were randomly allocated to an intervention group or a control group. The intervention included supervised and home-based exercises focused on postural organization, breathing coordination, and lumbopelvic-abdominal muscle control. The control group continued their usual activities without receiving the study intervention. Pelvic floor muscle function, abdominopelvic functional responses, respiratory function, and health-related quality of life were assessed.
- Conditions
- Pelvic Floor
- Being tested
- Multimodal Physiotherapy Exercise Programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Physiotherapy Exercise ProgrammeBehavioural
Participants completed a 12-week exercise programme combining postural organization, breathing coordination, and lumbopelvic-abdominal motor control. The programme included a 20-minute supervised session once weekly, complemented by home-based exercise.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants assigned to this group completed a 12-week physiotherapy exercise programme focused on postural organization, breathing coordination, and lumbopelvic-abdominal muscle control, combining supervised sessions with home-based exercise. Receives: Behavioral: Multimodal Physiotherapy Exercise Programme |
| Control group | No intervention | Participants assigned to this group continued their usual activities and did not receive the study exercise programme during the 12-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subumbilical Cough Test
Qualitative assessment of abdominal wall response during coughing. The outcome was categorized as no bulging or bulging of the abdominal wall. Bulging was defined as caudal bulging of the umbilicopubic region during the cough maneuver, indicating insufficient abdominal muscle activation.
Measured: Baseline and after the 12-week intervention
Secondary outcomes (9)
Pelvic Floor Muscle Strength - Modified Oxford Scale
Pelvic floor muscle strength was assessed by digital vaginal palpation using the Modified Oxford Scale, scored from 0 to 5, where 0 indicates no perceptible muscle contraction and 5 indicates a strong contraction.
Measured: Baseline and after the 12-week intervention
Pelvic Floor Muscle Endurance
Pelvic floor muscle endurance was assessed by vaginal perineometry. Participants performed three maximal pelvic floor muscle contractions, each maintained for as long as possible. Endurance was recorded as the duration of the sustained contraction, expressed in seconds.
Measured: Baseline and after the 12-week intervention
Pelvic Floor Muscle Contraction Pressure
Pelvic floor muscle contraction pressure was assessed by vaginal perineometry using a pressure probe. Participants performed three maximal pelvic floor muscle contractions, and contraction pressure was recorded in cmH2O.
Measured: Baseline and after the 12-week intervention
Abdominal Diastasis Functional Test
Abdominal wall function was assessed by palpation of the linea alba in the supraumbilical and infraumbilical regions, at rest and during trunk elevation. The test evaluated the presence or absence and location of abdominal diastasis and the response of the linea alba during abdominal muscle activation.
Measured: Baseline and after the 12-week intervention
Transversus Abdominis Activation Test
Abdominal wall response was assessed during maximal inspiration and expiration. During maximal expiration, the outcome was categorized according to whether the abdomen protruded ("pushes") or did not protrude ("does not push"), reflecting the activation response of the transversus abdominis.
Measured: Baseline and after the 12-week intervention
Forced Vital Capacity (FVC)
Forced vital capacity was assessed by forced spirometry using a DATOSPIR-120 spirometer. Three measurements were performed and the best measurement was recorded. FVC was expressed in liters.
Measured: Baseline and after the 12-week intervention
Forced Expiratory Volume in One Second (FEV1)
Forced expiratory volume in one second was assessed by forced spirometry using a DATOSPIR-120 spirometer. Three measurements were performed and the best measurement was recorded. FEV1 was expressed in liters.
Measured: Baseline and after the 12-week intervention
Peak Expiratory Flow (PEF)
Peak expiratory flow was assessed by forced spirometry using a DATOSPIR-120 spirometer. Three measurements were performed and the best measurement was recorded. PEF was expressed in liters per second (L/s).
Measured: Baseline and after the 12-week intervention
Health-Related Quality of Life - SF-12
Health-related quality of life was assessed using the 12-item Short Form Health Survey (SF-12). Physical and mental health component scores were calculated, with higher scores indicating better perceived health-related quality of life.
Measured: After the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startNov 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic FloorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María de los Ángeles Sirvent Pinar, Universidad Miguel Hernandez de Elche
- Investigators
- Luís Gómez Pérez, PhD, Principal investigator, Universidad Miguel Hernández
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848451
- Sponsor's protocol ID
- DPC.LGP.01.17
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No prospective plan for individual participant data sharing was established for this study.
Publications
Sirvent-Pinar MA, Iglesias-Comesaña A, Guerrero-Rubio MA, Alarcón-Alarcón D, Rodríguez-Blanco N, Pérez de Arrilucea Le Floc'h U. Development and reproducible description of a multimodal physiotherapy intervention for pelvic floor health: a methodological report. BMC Women's Health. 2026. doi:10.1186/s12905-026-04779-3.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiotherapy Exercise Programme Based on Hypopressive Exercise as Adjunctive Muscle Training for the Primary Prevention of Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT07848451
- Acronym / sponsor ID
- DPC.LGP.01.17
- Conditions
- Pelvic Floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Sep 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.
This study evaluated the effects of a 12-week physiotherapy exercise programme on pelvic floor and abdominopelvic function in healthy young nulliparous women. Participants were randomly allocated to an intervention group or a control group. The intervention included supervised and home-based exercises focused on postural organization, breathing coordination, and lumbopelvic-abdominal muscle control. The control group continued their usual activities without receiving the study intervention. Pelvic floor muscle function, abdominopelvic functional responses, respiratory function, and health-related quality of life were assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Multimodal Physiotherapy Exercise ProgrammeParticipants assigned to this group completed a 12-week physiotherapy exercise programme focused on postural organization, breathing coordination, and lumbopelvic-abdominal muscle control, combining supervised sessions with home-based exercise. |
| Control group | No intervention | –Participants assigned to this group continued their usual activities and did not receive the study exercise programme during the 12-week study period. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female university students aged 18 to 26 years.
- Nulliparous.
- No gynecological pathology.
- No respiratory pathology.
- History of sexual intercourse.
Key exclusion criteria (1 listed)
- Failure to meet any of the inclusion criteria.
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 |
|---|---|---|
| Multimodal Physiotherapy Exercise ProgrammeParticipants completed a 12-week exercise programme combining postural organization, breathing coordination, and lumbopelvic-abdominal motor control. The programme included a 20-minute supervised session once weekly, complemented by home-based exercise. | Behavioural | Intervention Group |
Primary outcome
Subumbilical Cough Test
Time frame: Baseline and after the 12-week intervention
Qualitative assessment of abdominal wall response during coughing. The outcome was categorized as no bulging or bulging of the abdominal wall. Bulging was defined as caudal bulging of the umbilicopubic region during the cough maneuver, indicating insufficient abdominal muscle activation.
9 secondary outcomes
Pelvic Floor Muscle Strength - Modified Oxford Scale
Time frame: Baseline and after the 12-week intervention
Pelvic Floor Muscle Endurance
Time frame: Baseline and after the 12-week intervention
Pelvic Floor Muscle Contraction Pressure
Time frame: Baseline and after the 12-week intervention
Abdominal Diastasis Functional Test
Time frame: Baseline and after the 12-week intervention
Transversus Abdominis Activation Test
Time frame: Baseline and after the 12-week intervention
Forced Vital Capacity (FVC)
Time frame: Baseline and after the 12-week intervention
Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline and after the 12-week intervention
Peak Expiratory Flow (PEF)
Time frame: Baseline and after the 12-week intervention
Health-Related Quality of Life - SF-12
Time frame: After the 12-week intervention
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 30 Sep 2026.
- BackgroundSirvent-Pinar MA, Iglesias-Comesaña A, Guerrero-Rubio MA, Alarcón-Alarcón D, Rodríguez-Blanco N, Pérez de Arrilucea Le Floc'h U. Development and reproducible description of a multimodal physiotherapy intervention for pelvic floor health: a methodological report. BMC Women's Health. 2026. doi:10.1186/s12905-026-04779-3.
- Individual participant dataSharing planned: No. No prospective plan for individual participant data sharing was established for this study.
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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.
Luís Gómez Pérez, PhD principal investigator
Universidad Miguel Hernández
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Physiotherapy Exercise Programme in people with Pelvic Floor, run by Universidad Miguel Hernandez de Elche.
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 5 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Subumbilical Cough Test (time frame: Baseline and after the 12-week intervention). 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 NCT07848451, which also lists 1 linked publication.
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 30 Sep 2026.