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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, October 2007

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

Genetics Home Reference related topics:   adenosine monophosphate deaminase deficiency   

MedlinePlus related topics:   Pelvic Support Problems    Rehabilitation   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

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 ]

Estimated Enrollment:   60
Study Start Date:   April 2006
Estimated Study Completion Date:   March 2008

  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


Study ID Numbers:   AH Urogynecology
First Received:   October 24, 2007
Last Updated:   October 24, 2007
ClinicalTrials.gov Identifier:   NCT00549458
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:
Neuromuscular Manifestations
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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