Cryotherapy EffectNCT02497495
Behaviour After Exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application
A study testing immersion cold water in people with Cryotherapy Effect, run by Paulista University at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- immersion cold water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- Healthy
- Aged between 18 and 30 years
- Classified as physically active through the International Physical Activity Questionnaire
Who cannot join
- Anemia
- Inflammation
- Diabetes
- Cardiovascular disease
- Liver problems
- Alcoholics
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cryotherapy Effect
- Being tested
- immersion cold water
- Keywords
- Immersion, Recovery of Function, Lactate, Creatine Kinase, Musculoskeletal Pain
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersion cold waterOther
immersion cold water at different temperatures and exposure times
| Study group | Role | What they receive |
|---|---|---|
| GC | No intervention | Control group - CG (n = 21), which suffered no recuperative technique |
| G1 | Experimental | G1 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 9±1 degrees Celsius Receives: Other: immersion cold water |
| G2 | Experimental | G2 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 14±1 degrees Celsius Receives: Other: immersion cold water |
| G3 | Experimental | G3 (n = 21) was subjected to a recovery procedure by immersion cold water for 15 minutes as from 9±1 degrees Celsius Receives: Other: immersion cold water |
| G4 | Experimental | G4 (n = 21) was subjected to a recovery procedure by immersion cold water for 15 minutes as from 14±1 degrees Celsius Receives: Other: immersion cold water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Creatine kinase using 5 ml samples of blood at 96 hours
Measured: 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
Measured: 3, 5, 7, 9, 11, 13, 15, 30, 45, 60 and 75 minutes of achievement of recuperative technique
Secondary outcomes (2)
Change from Baseline in leg pain using the Visual Analogue Scale at 96 hours
Measured: 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
Measured: 75 minutes, 24, 48, 72 and 96 hours after exercise protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franciele Marques Vanderle, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497495
- Sponsor's protocol ID
- 736.438
- Status last verified
- Jul 2015
- First submitted
- 7 Jul 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Post-exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application in Active Individuals
- ClinicalTrials.gov ID
- NCT02497495
- Acronym / sponsor ID
- 736.438
- Conditions
- Cryotherapy Effect
- Keywords
- Immersion, Recovery of Function, Lactate, Creatine Kinase, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GC | No intervention | –Control group - CG (n = 21), which suffered no recuperative technique |
| G1 | Experimental | Other: immersion cold waterG1 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 9±1 degrees Celsius |
| G2 | Experimental | Other: immersion cold waterG2 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 14±1 degrees Celsius |
| G3 | Experimental | Other: immersion cold waterG3 (n = 21) was subjected to a recovery procedure by immersion cold water for 15 minutes as from 9±1 degrees Celsius |
| G4 | Experimental | Other: immersion cold waterG4 (n = 21) was subjected to a recovery procedure by immersion cold water for 15 minutes as from 14±1 degrees Celsius |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male sex
- Healthy
- Aged between 18 and 30 years
- Classified as physically active through the International Physical Activity Questionnaire
Key exclusion criteria (10 listed)
- Anemia
- Inflammation
- Diabetes
- Cardiovascular disease
- Liver problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immersion cold waterimmersion cold water at different temperatures and exposure times | Other | G1, G2, G3, G4 |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immersion cold water in people with Cryotherapy Effect, run by Paulista University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.