Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer
3. august 2015 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Forventet)
3
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Doppler Ultrasound- velocity of blood flow
Tidsramme: 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
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one day
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Elaine Guirro, University of Sao Paulo- Ribeirao Preto- Brazil
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2015
Primær fullføring (Faktiske)
1. august 2015
Studiet fullført (Forventet)
1. juli 2016
Datoer for studieregistrering
Først innsendt
10. juni 2015
Først innsendt som oppfylte QC-kriteriene
3. august 2015
Først lagt ut (Anslag)
6. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. august 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HC-FMRP nº 810616/2014
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