NCT02748473

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

1.1 years

First QC Date

April 14, 2016

Last Update Submit

April 22, 2016

Conditions

Keywords

Pilates exercisespelvic floor muscle contraction

Outcome Measures

Primary Outcomes (1)

  • change in Oxford Scale

    evaluated the oxford scale

    baseline and 3 months

Secondary Outcomes (3)

  • change in pubovisceral muscle thickness

    baseline and 3 months

  • change in levator hiatus area

    baseline and 3 months

  • change in vaginal pressure

    baseline and 3 months

Study Arms (2)

pelvic floor muscle strength

OTHER

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

Other: Pilates Exercises programOther: Pelvic floor muscle strengthOther: 3D perineal ultrasound

Device: 3D perineal ultrasound

OTHER

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

Other: Pilates Exercises programOther: 3D perineal ultrasound

Interventions

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.

Device: 3D perineal ultrasoundpelvic 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

pelvic floor muscle strength

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 ultrasoundpelvic floor muscle strength

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 22, 2016

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

September 1, 2015

Last Updated

April 25, 2016

Record last verified: 2016-04