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

Phase 4

Completed

• Conditions: Pelvic Floor
• Interventions: Other: Exercise; Other: isoflavone; Other: placebo

• Registration Number: NCT03167827
• Lead Sponsor: Federal University of Uberlandia

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2016-12
• Study Completion: 2017-03
• Status Verified: 2017-05
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-25
• Last Update Submitted: 2017-05-25
• Study First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group placebo and exercise	Exercise	The placebo group received 100mg containing starch of corn.
Group isoflavone and exercise	isoflavone	The isoflavone group received daily 100mg of isoflavones.
Group placebo and exercise	placebo	The placebo group received 100mg containing starch of corn.
Group isoflavone and exercise	Exercise	The isoflavone group received daily 100mg of isoflavones.

Primary Outcome Measures

Name	Time	Method
The change vaginal squeeze pressure	before and after the intervetion ( 10 weeks)	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.
The change Muscle function	before and after the intervetion (10 weeks)	"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.
The change electromyography pelvic floor	before and after the intervetion (10 weeks)	"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.