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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor
• Intervention / Treatment: Other: Exercise; Other: isoflavone; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group isoflavone and exercise; The isoflavone group received daily 100mg of isoflavones.	Other: Exercise; 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.; Other: isoflavone; Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).
Placebo Comparator: Group placebo and exercise; The placebo group received 100mg containing starch of corn.	Other: Exercise; 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.; Other: placebo; Daily supplementation in 1 capsule per day containing starch of corn.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia

Publications and helpful links

General Publications

• Arab AM, Behbahani RB, Lorestani L, Azari A. Correlation of digital palpation and transabdominal ultrasound for assessment of pelvic floor muscle contraction. J Man Manip Ther. 2009;17(3):e75-9. doi: 10.1179/jmt.2009.17.3.75E.
• Pereira VS, Hirakawa HS, Oliveira AB, Driusso P. Relationship among vaginal palpation, vaginal squeeze pressure, electromyographic and ultrasonographic variables of female pelvic floor muscles. Braz J Phys Ther. 2014 Sep-Oct;18(5):428-34. doi: 10.1590/bjpt-rbf.2014.0038. Epub 2014 Oct 10.
• Bo K, Finckenhagen HB. Vaginal palpation of pelvic floor muscle strength: inter-test reproducibility and comparison between palpation and vaginal squeeze pressure. Acta Obstet Gynecol Scand. 2001 Oct;80(10):883-7. doi: 10.1034/j.1600-0412.2001.801003.x.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: exercise; pelvic floor; climateric; Supplementation of Isoflavone
• Other Study ID Numbers: CEP UFU 52969515.1.0000.5152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No