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

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.

Study Overview

• Status: Completed
• Conditions: Sedentary Lifestyle
• Intervention / Treatment: Other: Pilates Exercises program; Other: Pelvic floor muscle strength; Other: 3D perineal ultrasound

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: pelvic floor muscle strength; evaluated pelvic floor muscle strength before and after Pilates exercises program on sedentary nulliparous women	Other: Pilates Exercises program; 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.; Other: Pelvic floor muscle strength; 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; Other: 3D perineal ultrasound; 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
Other: Device: 3D perineal ultrasound; evaluated the pubovisceral muscle thickness and the levator hiatus area before and after Pilates exercises program on sedentary nulliparous women	Other: Pilates Exercises program; 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.; Other: 3D perineal ultrasound; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Oxford Scale	evaluated the oxford scale	baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pubovisceral muscle thickness	evaluated the pubovisceral muscle thickness	baseline and 3 months
change in levator hiatus area	evaluated the levator hiatus area	baseline and 3 months
change in vaginal pressure	evaluated the vaginal pressure ( perineometer)	baseline and 3 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Pilates exercises; pelvic floor muscle contraction
• Other Study ID Numbers: LTS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED