Athletic PerformanceNCT02688972
The Accumulative Effect of Cold Water Immersion in Football Athletes
A study testing cold water immersion in people with Athletic Performance, run by Scheila Marisa Pinheiro.
Trial summary
Football is a sport with congested calendars, which requires muscle recovery strategies such as cold water immersion (CWI). This recovery technique is well spread through football clubs, although it lacks a profound physiologic investigation to understand its effects on athlete's body. Read more about this study
- Who is it for?
- Ages 17 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- cold water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Aug 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 17 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy subjects
- Soccer players
Who cannot join
- Neurological, vascular or systemic muscle disease
About this study
Football is a sport with congested calendars, which requires muscle recovery strategies such as cold water immersion (CWI). This recovery technique is well spread through football clubs, although it lacks a profound physiologic investigation to understand its effects on athlete's body. Objectives: The main objective of this study is to evaluate the effect of a long-term CWI exposure in football athlete's.
Study Hypothesis:
Read more
H0: The application of Cold water immersion doesn't amend the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.
H1: The application of Cold water immersion amends the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.
Read the detailed description
In order to answer this question, the investigators performed a randomized clinical trial in 23 sub-20 football athletes. All subjects were randomly divided into two groups; a control group (10 minutes seated rest) and a CWI group (10 minutes in a 10 degree C) during seven days in a row. The investigators evaluated creatine kinase (CK) and lactate dehydrogenase (LDH) as molecular biomarkers for muscle damage. The blood samples were collected on the first, second, ninth and tenth days. Yet, the investigators assessed the peak of muscle activity and isometric strength of the knee flexors and extensors, potency of lower limbs, perceived exertion (PE) and total quality recovery perceived (TQRPer) in order to understand the treatment physiological effect on the subjects on the first and last day of experiments (before and after training).
- Conditions
- Athletic Performance
- Being tested
- cold water immersion, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold water immersionOther
The volunteers stayed immerged up to the iliac crest, in the water with water. The temperature utilized was 10 degree C and the time was 10 minutes
Control groupOther
The volunteers stayed in rest about 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| cold water immersion | Experimental | Not described Receives: Other: cold water immersion |
| control | Other | 13 volunteers Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Markers: Creatine Kinase
The creatine kinase was evaluated though blood samples.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Athletic PerformanceStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scheila Marisa Pinheiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Scheila Marisa Pinheiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688972
- Sponsor's protocol ID
- 861.084
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pinheiro SM, Dantas GAF, Silva LDR, Trajano GS, Barbosa GM, Dantas PMS. Effects of multiple cold-water immersion during pre-season on recovery performance in under-20 male soccer players: A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:563-568. doi: 10.1016/j.jbmt.2024.05.004. Epub 2024 May 18.
PubMed 39593644
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accumulative Effect of Cold Water Immersion in Football Athletes
- ClinicalTrials.gov ID
- NCT02688972
- Acronym / sponsor ID
- 861.084
- Conditions
- Athletic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Scheila Marisa PinheiroUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Feb 2016 (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.
Football is a sport with congested calendars, which requires muscle recovery strategies such as cold water immersion (CWI). This recovery technique is well spread through football clubs, although it lacks a profound physiologic investigation to understand its effects on athlete's body. Objectives: The main objective of this study is to evaluate the effect of a long-term CWI exposure in football athlete's.
Study Hypothesis:
H0: The application of Cold water immersion doesn't amend the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.
H1: The application of Cold water immersion amends the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.
Detailed description
In order to answer this question, the investigators performed a randomized clinical trial in 23 sub-20 football athletes. All subjects were randomly divided into two groups; a control group (10 minutes seated rest) and a CWI group (10 minutes in a 10 degree C) during seven days in a row. The investigators evaluated creatine kinase (CK) and lactate dehydrogenase (LDH) as molecular biomarkers for muscle damage. The blood samples were collected on the first, second, ninth and tenth days. Yet, the investigators assessed the peak of muscle activity and isometric strength of the knee flexors and extensors, potency of lower limbs, perceived exertion (PE) and total quality recovery perceived (TQRPer) in order to understand the treatment physiological effect on the subjects on the first and last day of experiments (before and after training).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold water immersion | Experimental | Other: cold water immersion |
| control | Other | Other: Control group13 volunteers |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- Soccer players
Key exclusion criteria (1 listed)
- Neurological, vascular or systemic muscle disease
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 |
|---|---|---|
| cold water immersionThe volunteers stayed immerged up to the iliac crest, in the water with water. The temperature utilized was 10 degree C and the time was 10 minutes | Other | cold water immersion |
| Control groupThe volunteers stayed in rest about 10 minutes | Other | control |
Primary outcome
Biochemical Markers: Creatine Kinase
Time frame: 10 days
The creatine kinase was evaluated though blood samples.
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 23 Feb 2016.
- Derived from this study: PubMed 39593644Pinheiro SM, Dantas GAF, Silva LDR, Trajano GS, Barbosa GM, Dantas PMS. Effects of multiple cold-water immersion during pre-season on recovery performance in under-20 male soccer players: A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:563-568. doi: 10.1016/j.jbmt.2024.05.004. Epub 2024 May 18.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing cold water immersion in people with Athletic Performance, run by Scheila Marisa Pinheiro.
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 2 inclusion and 1 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Biochemical Markers: Creatine Kinase (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02688972, which also lists 1 linked publication.
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 23 Feb 2016.