Randomized Controlled Trial Comparing Traditional Pelvic Floor Rehabilitation to Pilates in Increasing Pelvic Muscles Strength.
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2006
Typical duration for not_applicable
1 active site
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
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedSeptember 18, 2009
September 1, 2009
1.9 years
October 24, 2007
September 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase pelvic floor strength
Over a 12 week period of time
Interventions
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.
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 Criteria
You may qualify if:
- Women 18 yrs or older
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Office of Urogynecolgy 95 Madison Avenue Suite 204
Morristown, New Jersey, 07960, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Culligan, MD
Atlantic Health Urogynecology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 25, 2007
Study Start
April 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2009
Last Updated
September 18, 2009
Record last verified: 2009-09