Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer
3 augustus 2015 bijgewerkt door: Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
With increasing survival of women treated for breast cancer, it becomes necessary to evaluate the effect of therapeutic resources in morbidity due to surgical treatment of breast cancer.
The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer.
The study will be conducted according to design random cross over and wash out period of 7 days.
They will be evaluated 30 volunteers aged between 45 and 70 years, submitted to treatment of breast cancer.
The volunteers will be submitted to three different therapeutic procedures applied randomly by lot: active exercises, functional compressive bandaging with active exercises and elastic compression with active exercises.
The profile of blood flow, including speed and direction, will be assessed by Doppler ultrasound before and after, at 0, 15, 30 minutes.
Normality will be verified by the Shapiro-Wilk test, and the effect of behavior between pre- and post-intervention will be evaluated by ANOVA two-way followed by post-hoc test Friedman followed rank, p <0.05 .
The data obtained in the study are intended to enhance the forms of physical therapy intervention in the face of circulatory morbidities resulting from breast cancer treatments.
Studietype
Ingrijpend
Inschrijving (Verwacht)
3
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
- diagnosed with moderate to severe unilateral lymphedema
Exclusion Criteria:
- Women with muscle-tendon injury and / or joint damage in the -affected limb,
- skin disorders,
- diabetes,
- circulatory disease not controlled, -chemotherapy
- radiotherapy,
- diagnostic with metastasis in the upper limb
- women pregnancy.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: therapeutic exercises
The applied therapeutic exercises involve shoulder movements including flexion, extension, abduction, adduction, internal and external rotation in isolated or combined movements, with ten repetitions of each movement, associated with the music, and stretching movements finalizing the sequence of movements.
|
The applied therapeutic exercises involve shoulder movements including flexion, extension, abduction, adduction, internal and external rotation in isolated or combined movements, with ten repetitions of each movement, associated with the music, and stretching movements finalizing the sequence of movements.
|
|
Actieve vergelijker: elastic compression
exercises for upper limb will be performed for an hour associated with the use of elastic compression.
Elastic compression will be effected through a clamp brand compression of 30-40 mmHg according to the measures of voluntary member.
|
exercises for upper limb will be performed for an hour associated with the use of elastic compression.
Elastic compression will be effected through a clamp brand compression of 30-40 mmHg according to the measures of voluntary member.
|
|
Actieve vergelijker: functional compressive bandaging
exercises for upper limb will be performed for an hour associated with the use of functional compressive bandaging.
The functional compressive bandaging will be held with the volunteer sitting with ipsilateral upper limb resting on the support surgery.
After hydration member a cotton mesh is used to prevent friction density 1cm strip of foam on the member to be wrapped.
Elastic bandages of cotton will be involved 5 cm, 10 cm, 15 cm from the fingers to the axillary region multilayered
|
exercises for upper limb will be performed for an hour associated with the use of functional compressive bandaging.
The functional compressive bandaging will be held with the volunteer sitting with ipsilateral upper limb resting on the support surgery.
After hydration member a cotton mesh is used to prevent friction density 1cm strip of foam on the member to be wrapped.
Elastic bandages of cotton will be involved 5 cm, 10 cm, 15 cm from the fingers to the axillary region multilayered
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Doppler Ultrasound- velocity of blood flow
Tijdsspanne: one day
|
Doppler ultrasound is used to measure the velocity of blood flow of the axillary and brachial vein of the upper limb with lymphedema
|
one day
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elaine Guirro, University of Sao Paulo- Ribeirao Preto- Brazil
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2015
Primaire voltooiing (Werkelijk)
1 augustus 2015
Studie voltooiing (Verwacht)
1 juli 2016
Studieregistratiedata
Eerst ingediend
10 juni 2015
Eerst ingediend dat voldeed aan de QC-criteria
3 augustus 2015
Eerst geplaatst (Schatting)
6 augustus 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
6 augustus 2015
Laatste update ingediend die voldeed aan QC-criteria
3 augustus 2015
Laatst geverifieerd
1 augustus 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HC-FMRP nº 810616/2014
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .