Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000299202
Ethics application status
Approved
Date submitted
20/03/2009
Date registered
19/05/2009
Date last updated
19/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Variation of skin temperature before, during and after contrast bath therapy
Scientific title
Variation of skin temperature before, during and after contrast bath therapy in healthy volunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
effect of contrast bath therapy on skin temperature. 4504 0
healthy human volunteers 4703 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4784 4784 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials and methods: 20 volunteers were used randomly separated into two groups of 10 to be submitted to two protocols, A (starting therapy with immersion in water heated and ending in cold water) and B (starting therapy with immersion in water Cold and ending with heated water). Group A: 4 minutes immersion in hot water bath (40 degrees celsius), immediately followed by 1 minute immersion in cold water bath (15 degrees celsius); Group B: 1 minute immersion in cold water bath (15 degrees celsius), immediately followed by 4 minutes immersion in hot water bath (40 degrees celsius). We used an infrared thermometer to check the temperature of the skin before, during and after the bath of contrast.
Intervention code [1] 4254 0
Rehabilitation
Intervention code [2] 4466 0
Lifestyle
Comparator / control treatment
the comparator control group was the left segment (left leg), where was only meansured the temperature without treatment.
the comparator control group only had temperature measured on the left segment (left leg) with no additional therapies.
Control group
Active

Outcomes
Primary outcome [1] 5644 0
skin temperature was measured at the left/right ankle using an infrared thermometer.
Timepoint [1] 5644 0
immediately prior to treatment, every 5 minute during treatment, every 5 minute for 10 minutes post treatment.
Secondary outcome [1] 241530 0
none
Timepoint [1] 241530 0
none

Eligibility
Key inclusion criteria
healthy volunteers, college students, both gender, age (18 to 30 year), and body mass index betwen (20 to 25).
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
loss sensibility, heart failure, pheripheral neurophaty, obesity, systemic or metabolic disease, skin disease, recent feet trauma.

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



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1692 0
Brazil
State/province [1] 1692 0
rio de janeiro

Funding & Sponsors
Funding source category [1] 4690 0
Self funded/Unfunded
Name [1] 4690 0
Country [1] 4690 0
Brazil
Primary sponsor type
University
Name
castelo branco
Address
av. santa cruz, 1631 - realengo - RJ
postal code: 21710-250.
Country
Brazil
Secondary sponsor category [1] 4235 0
Individual
Name [1] 4235 0
vagner sa
Address [1] 4235 0
av, santa cruz, 1631, realengo, RJ
postal code: 21710-250.
Country [1] 4235 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6729 0
ethical comitee of Castelo Branco University
Ethics committee address [1] 6729 0
Ethics committee country [1] 6729 0
Brazil
Date submitted for ethics approval [1] 6729 0
01/07/2008
Approval date [1] 6729 0
01/08/2008
Ethics approval number [1] 6729 0
0105/2008

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

Contacts
Principal investigator
Name 29417 0
Address 29417 0
Country 29417 0
Phone 29417 0
Fax 29417 0
Email 29417 0
Contact person for public queries
Name 12664 0
vagner sa
Address 12664 0
av. santa cruz, 1631, realengo RJ - 21710-250.
Country 12664 0
Brazil
Phone 12664 0
55-21-2406-7700
Fax 12664 0
Email 12664 0
[email protected]
Contact person for scientific queries
Name 3592 0
vagner sa
Address 3592 0
av. santa cruz, 1631, realengo RJ - 21710-250.
Country 3592 0
Brazil
Phone 3592 0
55-21-2406-7700
Fax 3592 0
Email 3592 0
[email protected]

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.