Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program
1 other identifier
interventional
57
0 countries
N/A
Brief Summary
Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve the pelvic floor muscle strength on sedentary nulliparous women.
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 May 2012
Longer than P75 for not_applicable
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
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedApril 25, 2016
April 1, 2016
1.1 years
April 14, 2016
April 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in Oxford Scale
evaluated the oxford scale
baseline and 3 months
Secondary Outcomes (3)
change in pubovisceral muscle thickness
baseline and 3 months
change in levator hiatus area
baseline and 3 months
change in vaginal pressure
baseline and 3 months
Study Arms (2)
pelvic floor muscle strength
OTHERevaluated pelvic floor muscle strength before and after Pilates exercises program on sedentary nulliparous women
Device: 3D perineal ultrasound
OTHERevaluated the pubovisceral muscle thickness and the levator hiatus area before and after Pilates exercises program on sedentary nulliparous women
Interventions
The volunteers were divided in two groups: Group I: Pilates exercise program involving only the Pilates exercises protocol Group II: Pilates exercises program with voluntary pelvic floor muscle contraction. The protocol of both groups consisted of 24 bi-weekly 1-h individual sessions of Pilates exercises program. Both groups performed the same protocol . For the group PEP + PFMC the instructor asked for the maximum contraction muscle of the pelvic floor muscle, during expirations with 5 repetitions performed alternately, thus avoiding pelvic floor muscle exhaustion. After the 24 sessions, both groups were retested with the same measured methods of the baseline.
evaluated the pelvic floor strength by oxford scale and vaginal pressure before and after the 12 sessions with Pilates Exercises Program on sedentary nulliparous women
evaluated the pubovisceral muscle thickness and levator hiatus area by 3D perineal ultrasound before and after the 12 sessions with Pilates Exercises Program on sedentary nulliparous women
Eligibility Criteria
You may qualify if:
- healthy women (without any gynecologic/neurologic disease)
- sedentary women (do not practice regularly physical activities)
- nulliparous,
- on reproductive age
- with no history of pelvic floor disorders
- capable to perform correct PFMC.
You may not qualify if:
- Women were not included if they were not able to perform a correct PFMC.
- Potential subjects were excluded if they had chronic degenerative diseases affecting muscular and nerve tissues, diabetes, cerebrovascular disease or overt neurological conditions,
- pregnancy,
- autoimmune connective tissue disorders
- had previously undergone pelvic floor re-education programs and/or pelvic floor surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2016
First Posted
April 22, 2016
Study Start
May 1, 2012
Primary Completion
June 1, 2013
Study Completion
September 1, 2015
Last Updated
April 25, 2016
Record last verified: 2016-04