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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03167827
Enrollment
22
Registered
2017-05-30
Start date
2016-09-30
Completion date
2017-03-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor

Keywords

pelvic floor, climateric, exercise, Supplementation of Isoflavone

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.

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.

Interventions

OTHERExercise

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.

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

OTHERplacebo

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

Sponsors

Federal University of Uberlandia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Double Blind (Participant, Care Provider)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The change vaginal squeeze pressurebefore 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.
The change Muscle functionbefore 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.
The change electromyography pelvic floorbefore 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026