Randomized Controlled Trial Comparing Traditional Pelvic Floor Rehabilitation to Pilates in Increasing Pelvic Muscles Strength.
Primary Purpose
Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pilates
Pelvic muscle rehabilitation therapy
Sponsored by
About this trial
This is an interventional prevention trial for Muscle Weakness focused on measuring Week pelvic floor muscle in females
Eligibility 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.
Sites / Locations
- Office of Urogynecolgy 95 Madison Avenue Suite 204
Outcomes
Primary Outcome Measures
Increase pelvic floor strength
Secondary Outcome Measures
Full Information
NCT ID
NCT00549458
First Posted
October 24, 2007
Last Updated
September 17, 2009
Sponsor
Atlantic Health System
1. Study Identification
Unique Protocol Identification Number
NCT00549458
Brief Title
Randomized Controlled Trial Comparing Traditional Pelvic Floor Rehabilitation to Pilates in Increasing Pelvic Muscles Strength.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Atlantic Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Week pelvic floor muscle in females
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Pilates
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pelvic muscle rehabilitation therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase pelvic floor strength
Time Frame
Over a 12 week period of time
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Culligan, MD
Organizational Affiliation
Atlantic Health Urogynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Office of Urogynecolgy 95 Madison Avenue Suite 204
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Controlled Trial Comparing Traditional Pelvic Floor Rehabilitation to Pilates in Increasing Pelvic Muscles Strength.
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