Randomized Controlled Trial Comparing Traditional Pelvic Floor Rehabilitation to Pilates in Increasing Pelvic Muscles Strength.

September 17, 2009 updated by: Atlantic Health System

The objective of this randomized controlled trial is to determine whether a standardized Pilates exercise program can effectively strengthen pelvic floor muscles when compared with conventional pelvic muscle rehabilitation.

Urinary incontinence is a widespread problem that affects 10-40% of all ambulatory women and pelvic floor muscle training is an effective treatment for this problem. However, its efficacy is proportionate to the effort expended. Even among women who are diligent with pelvic muscle rehabilitation, long term follow-up reveals that benefits are lost in the absence of maintenance exercises.

While this intervention is effective, recent studies demonstrate that long term adherence to treatment is low. As compliance appears to be a prerequisite to achieving sustained benefit, finding a method of pelvic muscle strengthening that better lends itself to long term commitment could prove beneficial.

The currently popular exercise program, known as Pilates (named after founder, Joseph Pilates) consists of a series of low impact, flexibility and muscle toning exercises. The philosophy centers around developing core strength which includes strengthening the pelvic floor. Its use has been described in the US since the 1920s.4 Five million Americans currently participate, as opposed to five thousand ten years ago.5 Given its mainstream popularity, Pilates would be an appealing as a therapeutic modality for women experiencing pelvic muscle weakness. Currently, there are no studies that assess the efficacy of Pilates in increasing pelvic muscle strength.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Office of Urogynecolgy 95 Madison Avenue Suite 204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18 yrs or older

Exclusion Criteria:

  • Pregnancy
  • No pelvic organ prolapse beyond the hymenal ring.
  • Age or medical condition that make it difficult for patient to tolerate exam or follow verbal instructions.
  • Pacemakers
  • IUDs
  • Vaginal infections or urinary tract infections
  • Medical or physical conditions which exclude the proper performance of Pilates.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase pelvic floor strength
Time Frame: Over a 12 week period of time
Over a 12 week period of time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 24, 2007

First Posted (ESTIMATE)

October 25, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH Urogynecology

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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