Clinical trial NCT02748473: Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program
Official title: Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program: An Assessor-masked Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Pilates exercises
pelvic floor muscle contraction
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-04-22
Enrollment: 57
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in Oxford Scale
timeFrame: baseline and 3 months
Secondary outcomes:
measure: change in pubovisceral muscle thickness
timeFrame: baseline and 3 months
measure: change in levator hiatus area
timeFrame: baseline and 3 months
measure: change in vaginal pressure
timeFrame: baseline and 3 months
Other outcomes:
Locations:
Study officials:
References: