- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02497495
Behaviour After Exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application
July 10, 2015 updated by: Franciele Marques Vanderle, Paulista University
Effects Post-exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application in Active Individuals
Introduction: immersion cold water is a recuperative strategy commonly used, however, are not yet fully understood the real effects of this technique on specific conditions.
Objective: To analyze and to compare the effects of the immersion cold water during the intense post-exercise recovery, using different times and temperatures on biological, clinical and metabolic variables.
Method: 105 male subjects were divided into five groups: one control group (CG) and four recoveries (G1: 5' at 9±1 degrees Celsius; G2: 5' at 14±1 degrees Celsius; G3: 15' at 9±1 degrees Celsius; G4: 15' at 14±1 degrees Celsius).
The volunteers were submitted an exhaustion protocol that consisted of a program of jumps and the Wingate test.
Immediately after the exhaustion protocol, volunteers were directed to a tank with water and ice, which were immersed up to the height of the anterior superior iliac spine to the recovery procedure, during which blood samples were collected for later analysis lactate and creatine kinase (CK).
Variables were collected prior to the exercise, 24, 48, 72 and 96 hours after the end of it.
Furthermore, the perception of pain and recovery of the lower limbs were also collected at specific moments by means respectively of the Likert scale of perceived effort and visual analogue scale pain.
Appropriate statistical analysis was used to compare the groups and the moments, considering the 5% level of significance.
Study Overview
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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Presidente Prudente, SP, Brazil, 55
- Franciele Marques Vanderlei
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 26 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male sex
- Healthy
- Aged between 18 and 30 years
- Classified as physically active through the International Physical Activity Questionnaire
Exclusion Criteria:
- Anemia
- Inflammation
- Diabetes
- Cardiovascular disease
- Liver problems
- Alcoholics
- Smokers
- Illicit drug users
- Chronic users of anti-inflammatory drugs
- Episode of musculotendinous or osteoarticular injury in the lower and/or column members during the last six months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: GC
Control group - CG (n = 21), which suffered no recuperative technique
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|
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Experimental: G1
G1 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 9±1 degrees Celsius
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immersion cold water at different temperatures and exposure times
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|
Experimental: G2
G2 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 14±1 degrees Celsius
|
immersion cold water at different temperatures and exposure times
|
|
Experimental: G3
G3 (n = 21) was subjected to a recovery procedure by immersion cold water for 15 minutes as from 9±1 degrees Celsius
|
immersion cold water at different temperatures and exposure times
|
|
Experimental: G4
G4 (n = 21) was subjected to a recovery procedure by immersion cold water for 15 minutes as from 14±1 degrees Celsius
|
immersion cold water at different temperatures and exposure times
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in Creatine kinase using 5 ml samples of blood at 96 hours
Time Frame: 24, 48, 72 and 96 hours after exercise protocol
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24, 48, 72 and 96 hours after exercise protocol
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Change from Baseline in Lactate by means of 25 μl of arterial blood from the ear lobe at 74 minutes
Time Frame: 3, 5, 7, 9, 11, 13, 15, 30, 45, 60 and 75 minutes of achievement of recuperative technique
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3, 5, 7, 9, 11, 13, 15, 30, 45, 60 and 75 minutes of achievement of recuperative technique
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in leg pain using the Visual Analogue Scale at 96 hours
Time Frame: 24, 48, 72 and 96 hours after exercise protocol
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24, 48, 72 and 96 hours after exercise protocol
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Change from Baseline in Perception recovery through the scale of perceived effort Likert at 96 hours
Time Frame: 75 minutes, 24, 48, 72 and 96 hours after exercise protocol
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75 minutes, 24, 48, 72 and 96 hours after exercise protocol
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
July 7, 2015
First Submitted That Met QC Criteria
July 10, 2015
First Posted (Estimate)
July 14, 2015
Study Record Updates
Last Update Posted (Estimate)
July 14, 2015
Last Update Submitted That Met QC Criteria
July 10, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 736.438
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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