Pelvic Floor DisordersNCT04343599
Hypopressive Effectiveness in Postural Control and Pelvic Floor.
A study testing Hypopressive exercises in people with Pelvic Floor Disorders and Postural; Defect, run by University of Jaén at 1 site in Spain.
Trial summary
Effects of an exercise program based on hypopressive exercises in the female population. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Postural; Defect, Muscle Weakness
- What is being tested?
- Hypopressive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 12 Jun 2019
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Physical autonomy
Who cannot join
- Vestibular disorders.
- Coronary diseases.
- Recent surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Effects of an exercise program based on hypopressive exercises in the female population.
Read the detailed description
Participants allocated to the intervention group completed 10 weeks of hypopressive exercises training with a frequency of two sessions of 30 minutes twice a week.
- Conditions
- Pelvic Floor Disorders, Postural; Defect, Muscle Weakness
- Being tested
- Hypopressive exercises
- Medical subject headings
- Pelvic Floor Disorders, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypopressive exercisesOther
The first two sessions will have as objective the correct and effective learning of the hypopressive technique. The rest of the sessions will be dedicated to the realization of an exercise protocol based on a progression of postures from standing to supine. Diaphragmatic apneas of approximately 7 seconds will be performed, alternating each apnea with three breaths.
| Study group | Role | What they receive |
|---|---|---|
| Hypopressive exercises | Experimental | Patients completed 10 weeks of abdominal hypopressive exercises with two sessions of 30 minutes per week. Receives: Other: Hypopressive exercises |
| Control group | No intervention | Patients allocated to the control group did not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control
Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy).
Measured: From baseline to 10 weeks.
Secondary outcomes (5)
Pelvic floor muscles strength
The assessment of the overall contractility of the striated pelvic floor musculature was evaluated according to the modified manual scale Oxford.
Measured: From baseline to 10 weeks.
Self-reported pelvic floor status
To assess self-reported status the Pelvic Floor Distress Inventory-Short Form was administered.
Measured: From baseline to 10 weeks
Urinary incontinence
To determine the presence and improvement in urinary incontinence the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form was employed.
Measured: From baseline to 10 weeks
Transversus abdominis activation
Transversus abdominis thickness during contraction was assessed by real time ultrasound imaging.
Measured: From baseline to 10 weeks.
Pulmonary ventilation
A forced spirometry test was employed to assess pulmonary function.
Measured: From baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Mar 2019
- Primary completion7 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Single group
- Model description
- This study was a single-blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID CRUZ DÍAZ, University of Jaén
- Investigators
- David Cruz-Díaz, Principal investigator, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343599
- Sponsor's protocol ID
- Hypouja
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Provided by reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypopressive Effectiveness in Postural Control and Pelvic Floor.
- ClinicalTrials.gov ID
- NCT04343599
- Acronym / sponsor ID
- Hypouja
- Conditions
- Pelvic Floor Disorders, Postural; Defect, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 13 Apr 2020 (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.
Effects of an exercise program based on hypopressive exercises in the female population.
Detailed description
Participants allocated to the intervention group completed 10 weeks of hypopressive exercises training with a frequency of two sessions of 30 minutes twice a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was a single-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Hypopressive exercises | Experimental | Other: Hypopressive exercisesPatients completed 10 weeks of abdominal hypopressive exercises with two sessions of 30 minutes per week. |
| Control group | No intervention | –Patients allocated to the control group did not receive any treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women
- Physical autonomy
Key exclusion criteria (3 listed)
- Vestibular disorders.
- Coronary diseases.
- Recent surgery.
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 |
|---|---|---|
| Hypopressive exercisesThe first two sessions will have as objective the correct and effective learning of the hypopressive technique. The rest of the sessions will be dedicated to the realization of an exercise protocol based on a progression of postures from standing to supine. Diaphragmatic apneas of approximately 7 seconds will be performed, alternating each apnea with three breaths. | Other | Hypopressive exercises |
Primary outcome
Postural control
Time frame: From baseline to 10 weeks.
Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy).
5 secondary outcomes
Pelvic floor muscles strength
Time frame: From baseline to 10 weeks.
Self-reported pelvic floor status
Time frame: From baseline to 10 weeks
Urinary incontinence
Time frame: From baseline to 10 weeks
Transversus abdominis activation
Time frame: From baseline to 10 weeks.
Pulmonary ventilation
Time frame: From baseline to 10 weeks
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 13 Apr 2020.
- Individual participant dataSharing planned: No. Provided by reasonable request.
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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.
David Cruz-Díaz principal investigator
University of Jaén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypopressive exercises in people with Pelvic Floor Disorders and Postural; Defect, run by University of Jaén at 1 site in Spain.
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 2 inclusion and 3 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 13 Apr 2020. 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 Spain. 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?
Postural control (time frame: From baseline to 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2020.