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

NCT03167827 | Completed Phase 4 DMC

• 1 other identifier: CEP UFU 52969515.1.0000.5152
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Floor

Keywords

pelvic floor; climateric; exercise; Supplementation of Isoflavone

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Group isoflavone and exercise

EXPERIMENTAL

The isoflavone group received daily 100mg of isoflavones.

Other: Exercise; Other: isoflavone

Group placebo and exercise

PLACEBO COMPARATOR

The placebo group received 100mg containing starch of corn.

Other: Exercise; Other: placebo

Interventions

Exercise OTHER

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.

Group isoflavone and exercise; Group placebo and exercise

isoflavone OTHER

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

Group isoflavone and exercise

placebo OTHER

Daily supplementation in 1 capsule per day containing starch of corn.

Group placebo and exercise

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Related 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. doi: 10.1179/jmt.2009.17.3.75E.

  PMID: 20046616 RESULT

• 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.

  PMID: 25372005 RESULT

• 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.

  PMID: 11580731 RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Isoflavones

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double Blind (Participant, Care Provider)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 30, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share