Sedentary LifestyleNCT02748473
Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program
A study testing Pilates Exercises program, Pelvic floor muscle strength and 3D perineal ultrasound in people with Sedentary Lifestyle, run by Federal University of São Paulo.
Trial summary
Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve the pelvic floor muscle strength on sedentary nulliparous women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Pilates Exercises program, Pelvic floor muscle strength and 3D perineal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Sep 2015
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy women (without any gynecologic/neurologic disease)
- sedentary women (do not practice regularly physical activities)
- nulliparous,
- on reproductive age
- with no history of pelvic floor disorders
- capable to perform correct PFMC.
Who cannot join
- Women were not included if they were not able to perform a correct PFMC.
- Potential subjects were excluded if they had chronic degenerative diseases affecting muscular and nerve tissues, diabetes, cerebrovascular disease or overt neurological conditions,
- pregnancy,
- autoimmune connective tissue disorders
- had previously undergone pelvic floor re-education programs and/or pelvic floor surgery.
About this study
Official title: Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program: An Assessor-masked Randomized Controlled Trial
Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve the pelvic floor muscle strength on sedentary nulliparous women.
Read the detailed description
Introduction: The purpose of this study was to evaluate the effectiveness of adding voluntary pelvic floor muscle contraction (PFMC) contraction to a Pilates exercise program on sedentary nulliparous women.
Methods: Fifty-seven healthy nulliparous and physically inactive women were randomized to Pilates exercise program (PEP) with or without PFMC. Forty-eight women concluded this study (24 participants for each group). Every women evaluated before and after the PEP, by a one physiotherapist and an urogynecologist (UG). Both professionals were not revealed to them. This physiotherapist measured their pelvic floor muscle strength by using both, a perineometer (Peritron) and vaginal palpation (Oxford Scale) . The UG, who performed 3D perineal ultrasound exams, collected their data and evaluated the results for pubovisceral muscle thickness and the levator hiatus (LA) area. Both professional were masked to the group allocation. The protocol for both groups consisted of 24 bi-weekly 1-h individual sessions of Pilates exercises, developed by another physiotherapist who is specialized in PFM rehabilitation and Pilates technique.
Group I: Pilates exercise program (PEP), involving only the Pilates exercises protocol without any instruction of a voluntary pelvic floor muscle contraction. I other words, the researcher had, under no circumstance, never explained anything about a voluntary pelvic floor muscle contraction during the Pilates exercise performance.
Group II: Pilates exercises program with voluntary pelvic floor muscle contraction (PEP+PFMC) composed of a Pilates exercises program with voluntary pelvic floor contractions. This included maximum contraction of the pelvic floor muscles during expiratory period with 5 repetitions alternately, thus avoiding any muscle exhaustion pelvic floor that could happen.
- Conditions
- Sedentary Lifestyle
- Being tested
- Pilates Exercises program, Pelvic floor muscle strength, 3D perineal ultrasound
- Keywords
- Pilates exercises, pelvic floor muscle contraction
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Exercises programOther
The volunteers were divided in two groups:
Group I: Pilates exercise program involving only the Pilates exercises protocol Group II: Pilates exercises program with voluntary pelvic floor muscle contraction.
The protocol of both groups consisted of 24 bi-weekly 1-h individual sessions of Pilates exercises program.
Both groups performed the same protocol . For the group PEP + PFMC the instructor asked for the maximum contraction muscle of the pelvic floor muscle, during expirations with 5 repetitions performed alternately, thus avoiding pelvic floor muscle exhaustion.
After the 24 sessions, both groups were retested with the same measured methods of the baseline.
Pelvic floor muscle strengthOther
evaluated the pelvic floor strength by oxford scale and vaginal pressure before and after the 12 sessions with Pilates Exercises Program on sedentary nulliparous women
3D perineal ultrasoundOther
evaluated the pubovisceral muscle thickness and levator hiatus area by 3D perineal ultrasound before and after the 12 sessions with Pilates Exercises Program on sedentary nulliparous women
| Study group | Role | What they receive |
|---|---|---|
| pelvic floor muscle strength | Other | evaluated pelvic floor muscle strength before and after Pilates exercises program on sedentary nulliparous women Receives: Other: Pilates Exercises program; Other: Pelvic floor muscle strength; Other: 3D perineal ultrasound |
| Device: 3D perineal ultrasound | Other | evaluated the pubovisceral muscle thickness and the levator hiatus area before and after Pilates exercises program on sedentary nulliparous women Receives: Other: Pilates Exercises program; Other: 3D perineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Oxford Scale
evaluated the oxford scale
Measured: baseline and 3 months
Secondary outcomes (3)
change in pubovisceral muscle thickness
evaluated the pubovisceral muscle thickness
Measured: baseline and 3 months
change in levator hiatus area
evaluated the levator hiatus area
Measured: baseline and 3 months
change in vaginal pressure
evaluated the vaginal pressure ( perineometer)
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Luiza Torelli de Souza, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748473
- Sponsor's protocol ID
- LTS-001
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program: An Assessor-masked Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02748473
- Acronym / sponsor ID
- LTS-001
- Conditions
- Sedentary Lifestyle
- Keywords
- Pilates exercises, pelvic floor muscle contraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve the pelvic floor muscle strength on sedentary nulliparous women.
Detailed description
Introduction: The purpose of this study was to evaluate the effectiveness of adding voluntary pelvic floor muscle contraction (PFMC) contraction to a Pilates exercise program on sedentary nulliparous women.
Methods: Fifty-seven healthy nulliparous and physically inactive women were randomized to Pilates exercise program (PEP) with or without PFMC. Forty-eight women concluded this study (24 participants for each group). Every women evaluated before and after the PEP, by a one physiotherapist and an urogynecologist (UG). Both professionals were not revealed to them. This physiotherapist measured their pelvic floor muscle strength by using both, a perineometer (Peritron) and vaginal palpation (Oxford Scale) . The UG, who performed 3D perineal ultrasound exams, collected their data and evaluated the results for pubovisceral muscle thickness and the levator hiatus (LA) area. Both professional were masked to the group allocation. The protocol for both groups consisted of 24 bi-weekly 1-h individual sessions of Pilates exercises, developed by another physiotherapist who is specialized in PFM rehabilitation and Pilates technique.
Group I: Pilates exercise program (PEP), involving only the Pilates exercises protocol without any instruction of a voluntary pelvic floor muscle contraction. I other words, the researcher had, under no circumstance, never explained anything about a voluntary pelvic floor muscle contraction during the Pilates exercise performance.
Group II: Pilates exercises program with voluntary pelvic floor muscle contraction (PEP+PFMC) composed of a Pilates exercises program with voluntary pelvic floor contractions. This included maximum contraction of the pelvic floor muscles during expiratory period with 5 repetitions alternately, thus avoiding any muscle exhaustion pelvic floor that could happen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pelvic floor muscle strength | Other | Other: Pilates Exercises program, Other: Pelvic floor muscle strength, Other: 3D perineal ultrasoundevaluated pelvic floor muscle strength before and after Pilates exercises program on sedentary nulliparous women |
| Device: 3D perineal ultrasound | Other | Other: Pilates Exercises program, Other: 3D perineal ultrasoundevaluated the pubovisceral muscle thickness and the levator hiatus area before and after Pilates exercises program on sedentary nulliparous women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- healthy women (without any gynecologic/neurologic disease)
- sedentary women (do not practice regularly physical activities)
- nulliparous,
- on reproductive age
- with no history of pelvic floor disorders
Key exclusion criteria (5 listed)
- Women were not included if they were not able to perform a correct PFMC.
- Potential subjects were excluded if they had chronic degenerative diseases affecting muscular and nerve tissues, diabetes, cerebrovascular disease or overt neurological conditions,
- pregnancy,
- autoimmune connective tissue disorders
- had previously undergone pelvic floor re-education programs and/or pelvic floor 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 |
|---|---|---|
| Pilates Exercises programThe volunteers were divided in two groups: Group I: Pilates exercise program involving only the Pilates exercises protocol Group II: Pilates exercises program with voluntary pelvic floor muscle contraction. The protocol of both groups consisted of 24 bi-weekly 1-h individual sessions of Pilates exercises program. Both groups performed the same protocol . For the group PEP + PFMC the instructor asked for the maximum contraction muscle of the pelvic floor muscle, during expirations with 5 repetitions performed alternately, thus avoiding pelvic floor muscle exhaustion. After the 24 sessions, both groups were retested with the same measured methods of the baseline. | Other | Device: 3D perineal ultrasound, pelvic floor muscle strength |
| Pelvic floor muscle strengthevaluated the pelvic floor strength by oxford scale and vaginal pressure before and after the 12 sessions with Pilates Exercises Program on sedentary nulliparous women | Other | pelvic floor muscle strength |
| 3D perineal ultrasoundevaluated the pubovisceral muscle thickness and levator hiatus area by 3D perineal ultrasound before and after the 12 sessions with Pilates Exercises Program on sedentary nulliparous women | Other | Device: 3D perineal ultrasound, pelvic floor muscle strength |
Primary outcome
change in Oxford Scale
Time frame: baseline and 3 months
evaluated the oxford scale
3 secondary outcomes
change in pubovisceral muscle thickness
Time frame: baseline and 3 months
change in levator hiatus area
Time frame: baseline and 3 months
change in vaginal pressure
Time frame: baseline and 3 months
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 25 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercises program, Pelvic floor muscle strength and 3D perineal ultrasound in people with Sedentary Lifestyle, run by Federal University of São Paulo.
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 6 inclusion and 5 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 25 Apr 2016. 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?
change in Oxford Scale (time frame: baseline and 3 months). 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 25 Apr 2016.