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

NCT ID: NCT02748473

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-09-30

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.

Conditions

Sedentary Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

pelvic floor muscle strength

evaluated pelvic floor muscle strength before and after Pilates exercises program on sedentary nulliparous women

Group Type: OTHER

Pilates Exercises program

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Device: 3D perineal ultrasound

evaluated the pubovisceral muscle thickness and the levator hiatus area before and after Pilates exercises program on sedentary nulliparous women

Group Type: OTHER

Pilates Exercises program

Intervention Type: 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.

3D perineal ultrasound

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Luiza Torelli de Souza

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LTS-001

Identifier Type: -

Identifier Source: org_study_id