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Sponsored by: |
Atlantic Health System |
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Information provided by: | Atlantic Health System |
ClinicalTrials.gov Identifier: | NCT00549458 |
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 |
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Muscle Weakness |
Behavioral: Pilates Procedure: Pelvic muscle rehabilitation therapy |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patrick Culligan, MD | 973-971-7267 | Patrick.Culligan@atlantichealth.org |
Contact: Janent Scherer, RN, BSN | 973-971-7424 | janet.scherer@atlantichhealth.org |
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 |
Principal Investigator: | Patrick Culligan, MD | Atlantic Health Urogynecology |
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 |
Week pelvic floor muscle in females |
Signs and Symptoms Muscular Diseases Musculoskeletal Diseases |
Asthenia Neurologic Manifestations Muscle Weakness |
Signs and Symptoms Neuromuscular Manifestations Pathologic Processes Muscular Diseases |
Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Muscle Weakness |