Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor in Women in the Postmenopausal Period
25 maj 2017 uppdaterad av: Natasha Morena Bazílio Silva, Federal University of Uberlandia
Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor Musculature in Women in the Postmenopausal Period: Controlled Randomized Clinical Trial
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Fas 4
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Group isoflavone and exercise
The isoflavone group received daily 100mg of isoflavones.
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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.
Dagligt tillskott i 1 kapsel per dag av 100 mg isoflavoner (innehållande 3,3 % genistein, 93,5 % dadzein och 3,2 % glycitein).
|
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Placebo-jämförare: Group placebo and exercise
The placebo group received 100mg containing starch of corn.
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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 containing starch of corn.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The change vaginal squeeze pressure
Tidsram: 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.
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before and after the intervetion ( 10 weeks)
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The change Muscle function
Tidsram: 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.
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before and after the intervetion (10 weeks)
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The change electromyography pelvic floor
Tidsram: 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.
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before and after the intervetion (10 weeks)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2016
Primärt slutförande (Faktisk)
1 december 2016
Avslutad studie (Faktisk)
1 mars 2017
Studieregistreringsdatum
Först inskickad
17 maj 2017
Först inskickad som uppfyllde QC-kriterierna
25 maj 2017
Första postat (Faktisk)
30 maj 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CEP UFU 52969515.1.0000.5152
Plan för individuella deltagardata (IPD)
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Nej
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Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
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