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Randomized Controlled Trial Comparing Traditional Pelvic Floor Rehabilitation to Pilates in Increasing Pelvic Muscles Strength.
This study is currently recruiting participants.
Verified by Atlantic Health System, January 2009
First Received: October 24, 2007   Last Updated: January 29, 2009   History of Changes
Sponsored by: Atlantic Health System
Information provided by: Atlantic Health System
ClinicalTrials.gov Identifier: NCT00549458
  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: Prevention, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

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
Estimated Study Completion Date: March 2009
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549458

Contacts
Contact: Patrick Culligan, MD 973-971-7267 Patrick.Culligan@atlantichealth.org
Contact: Janent Scherer, RN, BSN 973-971-7424 janet.scherer@atlantichhealth.org

Locations
United States, New Jersey
Office of Urogynecolgy 95 Madison Avenue Suite 204 Recruiting
Morristown, New Jersey, United States, 07960
Contact: Janet Scherer, RN, BSN     973-971-7424     janet.scherer@atlantichhealth.org    
Sponsors and Collaborators
Atlantic Health System
Investigators
Principal Investigator: Patrick Culligan, MD Atlantic Health Urogynecology
  More Information

No publications provided

Responsible Party: Atlantic Urogynocology ( Patrick Culligan, MD )
Study ID Numbers: AH Urogynecology
Study First Received: October 24, 2007
Last Updated: January 29, 2009
ClinicalTrials.gov Identifier: NCT00549458     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Asthenia
Neurologic Manifestations
Muscle Weakness

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

ClinicalTrials.gov processed this record on September 10, 2009