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NCT Number: NCT03167827

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

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.

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Key information

Conditions

Pelvic Floor Behavior Motor Activity

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

isoflavone

Other

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

Placebo

Other

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

Primary outcomes

  1. The change vaginal squeeze pressure

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 30, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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