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

• Sponsor: Atlantic Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT00549458
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Weakness	Behavioral: Pilates; Procedure: Pelvic muscle rehabilitation therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2009

Outcome Measures

Primary Outcome Measures

1. Increase pelvic floor strength [Over a 12 week period of time]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00549458
• Other Study ID Numbers: AH Urogynecology
• First Posted: Oct 25, 2007
• Last Update Posted: Sep 18, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Week pelvic floor muscle in females
• Additional relevant MeSH terms: Muscle Weakness

Study Results

No Results Posted as of Sep 18, 2009