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Completed

NCT Number: NCT02748473

Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program

Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve the pelvic floor muscle strength on sedentary nulliparous women.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pilates Exercises program

Other

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 strength

Other

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 ultrasound

Other

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

Primary outcomes

  1. change in Oxford Scale

    Time frame: baseline and 3 months

    evaluated the oxford scale

Secondary outcomes

  1. change in pubovisceral muscle thickness

    Time frame: baseline and 3 months

    evaluated the pubovisceral muscle thickness

  2. change in levator hiatus area

    Time frame: baseline and 3 months

    evaluated the levator hiatus area

  3. change in vaginal pressure

    Time frame: baseline and 3 months

    evaluated the vaginal pressure ( perineometer)

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program: An Assessor-masked Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Apr 22, 2016
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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