Health BehaviorNCT03094689
Cold Water Immersion in the Recovery of Markers of Muscle Damage of 10km Street Runners
A study testing Cold water immersion and Water immersion in people with Health Behavior, run by Universidade Federal do Rio Grande do Norte.
Trial summary
Objective: To analyze the effect of cold water immersion (CWI) on the recovery of clinical, biochemical, functional and neuromuscular markers of muscle damage in 10 km street runners. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Cold water immersion and Water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Apr 2017
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 18.5 and 30 kg/m2;
- Street runners for at least 6 months;
- Week frequency of at least 3 times;
- Do not present cardiopathies, muscles and neurological diseases;
Who cannot join
- Hypersensitivity or allergies to cryotherapy;
- Unable to complete the 10 km event on the day of the evaluation;
- Do not complete or perform any of the study procedures for any reason (phobias, do not withstand the exposure time).
About this study
Official title: Cold Water Immersion in the Recovery of Clinical, Biochemical, Functional and Neuromuscular Markers of Muscle Damage of 10km Street Runners: Clinical, Randomized and Blinded Trial
Objective: To analyze the effect of cold water immersion (CWI) on the recovery of clinical, biochemical, functional and neuromuscular markers of muscle damage in 10 km street runners.
Materials and Methods: This is a randomized, blinded trial in which 30 subjects, 10 km street runners, were randomly divided into three groups: control (gC), immersion (gI) and CWI (gCWI). The runners will be evaluated for clinical (subjective perception of exertion), biochemical (serum CK), functional (unipodal triple hop distance and shuttle test time) and neuromuscular variables by means of isokinetic variables (peak torque, total work and fatigue index). Volunteers will perform pre-assessment, immediately post-race and post-intervention, and 24-hour post-intervention. The data will be expressed by mean and standard deviation, analyzed in the statistical package SPSS 20.0. A significance level of 5% and a 95% confidence interval will be considered for all measures.
- Conditions
- Health Behavior
- Being tested
- Cold water immersion, Water immersion
- Keywords
- Physical activity, Muscle pain, Cryotherapy
- Medical subject headings
- Health Behavior, Motor Activity, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold water immersionOther
Water immersionOther
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Immersion group | Experimental | They will be immersed in a barrel of 200 liters of water (without ice) at room temperature, according to local conditions of temperature and humidity (Natal county - RN). They will be immersed to the height of the iliac crests for 10 minutes. Receives: Other: Water immersion |
| Cold water immersion group | Experimental | They will be immersed in a barrel of 200 liters of ice water at an average temperature of 10 ° C for 10 minutes. They will be immersed to the height of the iliac crests. Receives: Other: Cold water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective perception of pain.
The subjective perception of pain will be measured by means of the visual analogic scale based on the self-report of the level of pain.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startJan 2017
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094689
- Sponsor's protocol ID
- 1.441.252
- Status last verified
- Apr 2017
- First submitted
- 5 Jan 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Water Immersion in the Recovery of Clinical, Biochemical, Functional and Neuromuscular Markers of Muscle Damage of 10km Street Runners: Clinical, Randomized and Blinded Trial
- ClinicalTrials.gov ID
- NCT03094689
- Acronym / sponsor ID
- 1.441.252
- Conditions
- Health Behavior
- Keywords
- Physical activity, Muscle pain, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 29 Mar 2017 (actual)
- 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.
Objective: To analyze the effect of cold water immersion (CWI) on the recovery of clinical, biochemical, functional and neuromuscular markers of muscle damage in 10 km street runners.
Materials and Methods: This is a randomized, blinded trial in which 30 subjects, 10 km street runners, were randomly divided into three groups: control (gC), immersion (gI) and CWI (gCWI). The runners will be evaluated for clinical (subjective perception of exertion), biochemical (serum CK), functional (unipodal triple hop distance and shuttle test time) and neuromuscular variables by means of isokinetic variables (peak torque, total work and fatigue index). Volunteers will perform pre-assessment, immediately post-race and post-intervention, and 24-hour post-intervention. The data will be expressed by mean and standard deviation, analyzed in the statistical package SPSS 20.0. A significance level of 5% and a 95% confidence interval will be considered for all measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Immersion group | Experimental | Other: Water immersionThey will be immersed in a barrel of 200 liters of water (without ice) at room temperature, according to local conditions of temperature and humidity (Natal county - RN). They will be immersed to the height of the iliac crests for 10 minutes. |
| Cold water immersion group | Experimental | Other: Cold water immersionThey will be immersed in a barrel of 200 liters of ice water at an average temperature of 10 ° C for 10 minutes. They will be immersed to the height of the iliac crests. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body Mass Index between 18.5 and 30 kg/m2;
- Street runners for at least 6 months;
- Week frequency of at least 3 times;
- Do not present cardiopathies, muscles and neurological diseases;
Key exclusion criteria (3 listed)
- Hypersensitivity or allergies to cryotherapy;
- Unable to complete the 10 km event on the day of the evaluation;
- Do not complete or perform any of the study procedures for any reason (phobias, do not withstand the exposure time).
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 immersion | Other | Cold water immersion group |
| Water immersion | Other | Immersion group |
Primary outcome
Subjective perception of pain.
Time frame: Up to 10 weeks
The subjective perception of pain will be measured by means of the visual analogic scale based on the self-report of the level of pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
Related trials for Health Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
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 and Water immersion in people with Health Behavior, run by Universidade Federal do Rio Grande do Norte.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Apr 2017. 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?
Results are not available in the source record.
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?
Subjective perception of pain. (time frame: Up to 10 weeks). 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 28 Apr 2017.