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

Pelvic Floor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167827
• Other study ID #: CEP UFU 52969515.1.0000.5152
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2017
• Last updated: May 25, 2017
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor

Intervention

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.
• isoflavone
Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).
• placebo
Daily supplementation in 1 capsule per day containing starch of corn.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

References & Publications (3)

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. — View Citation

Bø 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. — View Citation

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. Epub 2014 Oct 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)