Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence

NCT ID: NCT05096936

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2023-01-19

Brief Summary

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The present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the Pilates method associated or not with photobiomodulation with static magnetic field. The sample will consist of women with stress urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade Cenecista de Bento Gonçalves.

Detailed Description

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Conditions

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Laser Therapy Urinary Incontinence,Stress Pilates Method

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pilates PBMT

This group will receive training in the Pilates method associated with the effective application of photobiomodulation.

Group Type EXPERIMENTAL

Pilates

Intervention Type OTHER

The solo Pilates method will be applied twice a week for 12 weeks using the following exercises:

20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front.

Photobiomodulation

Intervention Type OTHER

Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.

Pilates

This group will receive training in the Pilates method associated with the not effective (placebo) application of photobiomodulation.

Group Type EXPERIMENTAL

Pilates

Intervention Type OTHER

The solo Pilates method will be applied twice a week for 12 weeks using the following exercises:

20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front.

PBMT

This group will receive effective application of photobiomodulation and will not perform the pilates method training

Group Type PLACEBO_COMPARATOR

Photobiomodulation

Intervention Type OTHER

Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.

Interventions

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Pilates

The solo Pilates method will be applied twice a week for 12 weeks using the following exercises:

20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front.

Intervention Type OTHER

Photobiomodulation

Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.

Intervention Type OTHER

Other Intervention Names

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Pilates exercise Pilates Methods

Eligibility Criteria

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Inclusion Criteria

* Women between 30 and 60 years old;
* Present a clinical diagnosis of SUI;
* The patient must be available at pre-scheduled times for a period of 12 weeks, with full participation;
* The participant must agree with the methodology proposed by the project and, if so, must sign the TCLE as legal proof of their participation.

Exclusion Criteria

* Patients with urge urinary incontinence;
* Constant flow urinary incontinence and stress urinary incontinence during the gestational period (because these are possible transitory cases due to pregnancy);
* Women who have difficulty in understanding;
* Patients who have more than one absence per month during the interventions.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade de Caxias do Sul

OTHER

Sponsor Role lead

Responsible Party

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Thiago De Marchi, DR

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clínica Escola da Faculdade Cenecista de Bento Gonçalves Clínica Escola CNECBG

Bento Gonçalves, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Knorst MR, Resende TL, Santos TG, Goldim JR. The effect of outpatient physical therapy intervention on pelvic floor muscles in women with urinary incontinence. Braz J Phys Ther. 2013 Sep-Oct;17(5):442-9. doi: 10.1590/S1413-35552012005000117. Epub 2013 Oct 21. English, Portuguese.

Reference Type BACKGROUND
PMID: 24173346 (View on PubMed)

De Marchi T, Leal Junior EC, Bortoli C, Tomazoni SS, Lopes-Martins RA, Salvador M. Low-level laser therapy (LLLT) in human progressive-intensity running: effects on exercise performance, skeletal muscle status, and oxidative stress. Lasers Med Sci. 2012 Jan;27(1):231-6. doi: 10.1007/s10103-011-0955-5. Epub 2011 Jul 8.

Reference Type BACKGROUND
PMID: 21739259 (View on PubMed)

Coyne KS, Zhou Z, Thompson C, Versi E. The impact on health-related quality of life of stress, urge and mixed urinary incontinence. BJU Int. 2003 Nov;92(7):731-5. doi: 10.1046/j.1464-410x.2003.04463.x.

Reference Type BACKGROUND
PMID: 14616456 (View on PubMed)

de Almeida P, Lopes-Martins RA, De Marchi T, Tomazoni SS, Albertini R, Correa JC, Rossi RP, Machado GP, da Silva DP, Bjordal JM, Leal Junior EC. Red (660 nm) and infrared (830 nm) low-level laser therapy in skeletal muscle fatigue in humans: what is better? Lasers Med Sci. 2012 Mar;27(2):453-8. doi: 10.1007/s10103-011-0957-3. Epub 2011 Jul 22.

Reference Type BACKGROUND
PMID: 21814736 (View on PubMed)

Other Identifiers

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PBMT and IUE

Identifier Type: -

Identifier Source: org_study_id

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