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

This study has been completed.
Sponsor:
Information provided by:
Atlantic Health System
ClinicalTrials.gov Identifier:
NCT00549458
First received: October 24, 2007
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Muscle Weakness
Behavioral: Pilates
Procedure: Pelvic muscle rehabilitation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • Increase pelvic floor strength [ Time Frame: Over a 12 week period of time ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Pilates
    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.
    Procedure: Pelvic muscle rehabilitation therapy
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549458

Locations
United States, New Jersey
Office of Urogynecolgy 95 Madison Avenue Suite 204
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
Investigators
Principal Investigator: Patrick Culligan, MD Atlantic Health Urogynecology
  More Information

No publications provided

Responsible Party: Patrick Culligan, MD, Atlantic Urogynocology
ClinicalTrials.gov Identifier: NCT00549458     History of Changes
Other Study ID Numbers: AH Urogynecology
Study First Received: October 24, 2007
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic Health System:
Week pelvic floor muscle in females

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014