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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • SP
      • Presidente Prudente, SP, Brazil, 55
        • Franciele Marques Vanderlei

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: GC
Control group - CG (n = 21), which suffered no recuperative technique
Experimental: G1
G1 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 9±1 degrees Celsius
Other: immersion cold water
immersion cold water at different temperatures and exposure times
Experimental: G2
G2 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 14±1 degrees Celsius
Other: immersion cold water
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
Other: immersion cold water
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
Other: immersion cold water
immersion cold water at different temperatures and exposure times

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
24, 48, 72 and 96 hours after exercise protocol
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
3, 5, 7, 9, 11, 13, 15, 30, 45, 60 and 75 minutes of achievement of recuperative technique

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
24, 48, 72 and 96 hours after exercise protocol
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
75 minutes, 24, 48, 72 and 96 hours after exercise protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paulista University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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