Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor in Women in the Postmenopausal Period

Study Overview
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Brief Summary
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This study evaluates the effect of Physical Training and Supplementation of Isoflavone About Pelvic Floor Musculature in Women in the Postmenopausal period, and it has two groups the intervetion.

Detailed Description
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The practice of physical exercise and isoflavone supplementation are ways of treating symptoms of climacteric, there is a lack of evidence as to whether these therapeutics when associated are useful for improving the strength, function, contraction pressure, electrical activity of the pelvic floor musculature of women in the Postmenopausal period.

Official Title
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Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor Musculature in Women in the Postmenopausal Period: Controlled Randomized Clinical Trial

Conditions
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Pelvic Floor

Intervention / Treatment
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* Other: Exercise
* Other: isoflavone
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy postmenopausal woman to be able to practice exercises on treadmill and weight exercises without physical complications that prevent the execution of physical exercises have no history of cardiovascular disease, diabetes, renal pathologies or hypertension Present ability to contract the pelvic floor muscles Exclusion Criteria: Smokers Use hormone therapy or isoflavone Use drugs that interfere with lipid and antihypertensive metabolism Presence of cognitive impairment or neurological condition that could affect muscle activation Present urinary tract infection at the time of data collection Training pelvic floor muscle

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group isoflavone and exercise<br>The isoflavone group received daily 100mg of isoflavones. | Other: Exercise<br>* The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.<br>Other: isoflavone<br>* Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).<br>|
| Placebo Comparator: Group placebo and exercise<br>The placebo group received 100mg containing starch of corn. | Other: Exercise<br>* The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.<br>Other: placebo<br>* Daily supplementation in 1 capsule per day containing starch of corn.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change vaginal squeeze pressure | The vaginal squeeze pressure was measured through Perineometer.To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. Outcome Measure of the vaginal squeeze pressure is cmH20 or Pascal. | before and after the intervetion ( 10 weeks) | 
| The change Muscle function | PFM evaluation was performed by vaginal palpation .During vaginal palpation the physiotherapist introduced the index and middle fingers about 4cm inside the vagina, and requested to hold the maximum contraction of the PFM. Muscle function was classified by the Oxford Scale Modified that five grades of the force. | before and after the intervetion (10 weeks) | 
| The change electromyography pelvic floor | PFM electromyographic activity was collected during the resting to normalize the EMG data. No instruction regarding PFM contraction was given during the resting of the eight seconds. After, the volunteers were instructed to perform a maximal voluntary PFM contraction with the instruction to move inward and upward with the greatest possible force and to hold the contraction for five seconds. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. | before and after the intervetion (10 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor, climateric, exercise, Supplementation of Isoflavone