Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000413921
Ethics application status
Approved
Date submitted
26/09/2010
Date registered
20/04/2011
Date last updated
20/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of compression stockings have a synergistic effect with walking using treadmill in the late afternoon to reduce edema of the lower limbs.
Scientific title
The aim of this study will evaluate whether a association of elastic stockings and walk on the treadmill for a short time reduces leg edema.
Secondary ID [1] 252763 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of edema in the lower limbs 258265 0
Condition category
Condition code
Cardiovascular 258457 258457 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study will evaluate whether an association of elastic stockings and walking for a short period in the late afternoon (5 o'clock p.m.) after work day reduces leg edema. Volume changes of the both legs of sixteen patients (32 limbs), walk continuously on a treadmill for 30 minutes using elastic compression stockings in upper limbs, model 3/4(legs fold up to the knee) and 20-30 mmHg compression. Will be analyzed in a quantitative, cross-sectional study in order of arrival at the clinic. All participants should not use drugs and wear compression stocking during the days. The intervention will be once only after a day’s work in an air conditioned room with a treadmill and apparatus for volumetry. All evaluations will be tracked by researcher. The participants will submit to volumetry initial using the water displacement technique, held in a glass container sealed with silicone and plastic device (tap) water to flow when the leg emerged, the water flow is measured in milliliters. Subsequently required to put on 20/30 made-to-measure compression stockings; the compression will only be used for up to 30 minutes during activity. The patients walk on a treadmill for 30 minutes and after removing the stockings volumetry of the legs will again performed.
Intervention code [1] 257279 0
Prevention
Intervention code [2] 264447 0
Treatment: Other
Comparator / control treatment
Nill
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259292 0
The aim of this study will evaluate whether an association of elastic stockings and walking for a short period in the late afternoon (5 o'clock p.m.) after work day reduces leg edema. The evaluation will involve volumetry using the water displacement technique and subsequently required to put on 20/30 made-to-measure compression stockings; the compression will only be used for up to 30 minutes during activity.
Timepoint [1] 259292 0
The primary outcome is to evaluate the volume initial the limbs for volumetry before beginning the proposed activity and assess immediately after a 30 minutes of activity using compression stocking.
Secondary outcome [1] 265719 0
Nil
Timepoint [1] 265719 0
Nil

Eligibility
Key inclusion criteria
Subjects will be assessed without apparent disease, CEAP(Clinical, etiology, anatomy, pathophysiology), where: C0 are patients without venous insufficiency (no varices); C1 telangiectasia (microvarices) examined clinically before activity.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects that used elastic stocking in work activity
Subjects who were performing any medical treatment
A clinical examination revealed another feature in CEAP

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not Aplicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not aplicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 2937 0
Brazil
State/province [1] 2937 0

Funding & Sponsors
Funding source category [1] 257714 0
Self funded/Unfunded
Name [1] 257714 0
Cleusa Ema Quilici Belczak
Country [1] 257714 0
Brazil
Primary sponsor type
Individual
Name
Cleusa Ema Quilici Belczak
Address
Av. Tiradentes, 1081


CEP 87013-260 Maringa, Parana
Country
Brazil
Secondary sponsor category [1] 256932 0
None
Name [1] 256932 0
Address [1] 256932 0
Country [1] 256932 0
Other collaborator category [1] 251530 0
Individual
Name [1] 251530 0
Jose Maria Pereira de Godoy
Address [1] 251530 0
AV Constituicao, 1306
Sao Jose do Rio Preto-Sao Paulo
CEP:15025-120
Country [1] 251530 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259754 0
Centro Universitario de Maringa-CESUMAR
Ethics committee address [1] 259754 0
Ethics committee country [1] 259754 0
Brazil
Date submitted for ethics approval [1] 259754 0
Approval date [1] 259754 0
20/11/2009
Ethics approval number [1] 259754 0
1/09/0480

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31700 0
Address 31700 0
Country 31700 0
Phone 31700 0
Fax 31700 0
Email 31700 0
Contact person for public queries
Name 14947 0
Cleusa Ema Quilici Belczak
Address 14947 0
Av. Tiradentes, 1081

Maringa, Parana
CEP 87013-260
Country 14947 0
Brazil
Phone 14947 0
55 44 32245171
Fax 14947 0
Email 14947 0
cleusabelczak@yahoo.com.br
Contact person for scientific queries
Name 5875 0
Jose Maria Pereira de Godoy
Address 5875 0
Av Constituicao 1306
Sao Jose do Rio Preto-Sao Paulo
CEP: 15025-120
Country 5875 0
Brazil
Phone 5875 0
55 17 32326362
Fax 5875 0
Email 5875 0
godoyjmp@riopreto.com.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.