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

Sedentary Lifestyle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748473
• Other study ID #: LTS-001
• Status: Completed
• Phase: N/A
• First received: April 14, 2016
• Last updated: April 22, 2016
• Start date: May 2012
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Oxford Scale	evaluated the oxford scale	baseline and 3 months	No
Secondary	change in pubovisceral muscle thickness	evaluated the pubovisceral muscle thickness	baseline and 3 months	No
Secondary	change in levator hiatus area	evaluated the levator hiatus area	baseline and 3 months	No
Secondary	change in vaginal pressure	evaluated the vaginal pressure ( perineometer)	baseline and 3 months	No