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

• Sponsor: Federal University of Uberlandia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03167827
• Collaborator: (none)
• Enrollment: 22
• Arms: 2
• Actual Duration (Months): 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor	Other: Exercise; Other: isoflavone; Other: placebo	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel AssignmentParallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Double Blind (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor Musculature in Women in the Postmenopausal Period: Controlled Randomized Clinical Trial
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of Uberlandia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Natasha Morena Bazílio Silva, physiotherapist, Federal University of Uberlandia
• ClinicalTrials.gov Identifier: NCT03167827
• Other Study ID Numbers: CEP UFU 52969515.1.0000.5152
• First Posted: May 30, 2017
• Last Update Posted: May 30, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Natasha Morena Bazílio Silva, physiotherapist, Federal University of Uberlandia: pelvic floor; climateric; exercise; Supplementation of Isoflavone

Study Results

No Results Posted as of May 30, 2017