PainNCT02806609
Effect of Muscle Pain in Late Cold Water Immersion, Muscular Recruitment, Postural Control Dynamic and Sleep Quality
A study testing Cold water immersion, with 10 degrees, for 10 minutes, immersion in water at room temperature and active recovery - running in people with Pain and Sleep, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
Objective: To evaluate the effect of cold water immersion in elayed onset muscle soreness, muscle recruitment, dynamic postural control and quality of sleep in young soccer players. Read more about this study
- Who is it for?
- Ages 16 to 21 years, men onlyHealthy volunteers can take part
- What is being tested?
- Cold water immersion, with 10 degrees, for 10 minutes, immersion in water at room temperature and active recovery - running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2016to 3 May 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 16 to 21 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Soccer players
- Aged between 16 and 21 years
- Male
- Train at least 5 times a week
- No complaints of musculoskeletal pain or history of muscle injuries in the past six months
- Hired at the same club with the same demand for training and competitions
Who cannot join
- Allergy to cold
- Surgery of the lower limbs in the past six months
- Athletes in viral states (such as colds or flu)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Muscle Pain in Late Cold Water Immersion, Muscular Recruitment, Postural Control Dynamic and Sleep Quality in Soccer Athletes: Randomized Study and Blind
Objective: To evaluate the effect of cold water immersion in elayed onset muscle soreness, muscle recruitment, dynamic postural control and quality of sleep in young soccer players.
Methods: The sample will consist of 28 soccer players between 18 and 21 years of the same football club and with the same routine practices and games. At first athletes will respond to the IC and will be submitted to the test of a repetition maximum. After three days the athletes will analysis of muscle recruitment by electromyography and dynamic posture control through the force platform both during the time of shooting, moreover, will respond to scale the quality of sleep the previous night and one on pain, then they are instructed to perform a fatigue protocol for the quadriceps and then will be randomized to one of four intervention groups: cold water immersion, submersion in water at room temperature, or active recovery control. The same APPRAISAL be remade into three new moments, 24, 48 and 72 hours after the fatigue test.
Read more
Hypothesis: The variables will be considered: Pain intensity in the quadriceps muscle, quality of sleep the night after intervention protocol, electromyographic analysis of the rectus femoris, vastus medialis oblique and vastus lateralis at the time of shooting, as well as postural control when the shot off.
It is intended to establish the best way of recovery of late quadriceps muscle pain and contribute to the clinical practice of active recovery or rest in young soccer players.
Read the detailed description
The size and power of the sample was raised with use of sample size calculation, the Power and Sample Size program with a 95% confidence interval, alpha level of 5% and power of 80%, considering the mean and standard deviation of data DOMS study the Effects of Cold Water Immersion after Rugby Training on muscle Power and Biochemical Markers. Thus, the sample was set at 48 volunteers, 12 distributed to each of the four groups.
Participate in the study 28 soccer players, aged between 16 and 21 years, male, with training at least 5 times a week, no complaints of musculoskeletal pain or history of muscle injuries in the past six months, hired a same club with the same demand for training and competitions.
Exclusion criteria will be observed vascular problems, allergy to cold, surgery of the lower limbs in the past six months, athletes in viral states (such as colds or flu).
These will be randomized into four groups: cold water immersion (N = 7) immersion in water at room temperature (n = 7), active recovery (n = 7) and control (N = 7).
- Being tested
- Cold water immersion, with 10 degrees, for 10 minutes, immersion in water at room temperature, active recovery - running, rest in the chair
- Keywords
- football, cryotherapy, balance, electromyography
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold water immersion, with 10 degrees, for 10 minutesOther
cold water immersion
immersion in water at room temperatureOther
immersion in water at room temperature
active recovery - runningOther
active recovery
rest in the chairOther
rest in the chair
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Cold water immersion, with 10 degrees, for 10 minutes Receives: Other: Cold water immersion, with 10 degrees, for 10 minutes |
| Group 2 | Other | immersion in water at room temperature Receives: Other: immersion in water at room temperature |
| Group 3 | Other | active recovery - running Receives: Other: active recovery - running |
| Group 4 | Other | rest in the chair Receives: Other: rest in the chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual pain scale
Demirhan et al. (2015) showed reduced muscle pain with the application of cold water immersion in elite wrestlers. Visual analogue range, ranging from 0 to 10, where 0 is no pain and 10 is maximum pain.
Measured: change of pain within 72 hours
Secondary outcomes (3)
balance by force platform
Tano et al. (2015) did not establish differences in postural control after cryoimmune, but the results remain inconsistent.
Measured: before the intervention and 24, 48 and 72 hours, by force platform
muscle recruitment by electromyography
In a study carried out by Peter et al. (2015), CWI had no effects on the muscular response of physically active subjects. However, the assessment was performed immediately after the intervention, different from our study, which analyzed the effects of CWI immersion 72 hours after a DOMS-inducing protocol.
Measured: before the intervention and 24, 48 and 72 hours, by electromyography
Sleep measured by Visual Analog Scale
Robey et al. (2013) and Minet et al. (2015) found no effect of recovery methods on sleep quality of athletes. However, the relationship between sleep and performance has become a topic of great interest due to the growth of scientific evidence confirming the link between sleep and cognitive processes and metabolic functions in non-athletes. Spiegel's scale ranges from 1 to 5, where 5 means that he slept very well and 1 did not do well at all.
Measured: before the intervention and 24, 48 and 72 hours, by questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion30 Dec 2016
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Macedo, Universidade Estadual de Londrina
- Investigators
- Christiane Macedo, doctor, Principal investigator, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806609
- Sponsor's protocol ID
- COLD WATER IMMERSION
- Status last verified
- Dec 2017
- First submitted
- 4 May 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bleakley C, McDonough S, Gardner E, Baxter GD, Hopkins JT, Davison GW. Cold-water immersion (cryotherapy) for preventing and treating muscle soreness after exercise. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008262. doi: 10.1002/14651858.CD008262.pub2.
PubMed 22336838Buchheit M, Peiffer JJ, Abbiss CR, Laursen PB. Effect of cold water immersion on postexercise parasympathetic reactivation. Am J Physiol Heart Circ Physiol. 2009 Feb;296(2):H421-7. doi: 10.1152/ajpheart.01017.2008. Epub 2008 Dec 12.
PubMed 19074671
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Pain in Late Cold Water Immersion, Muscular Recruitment, Postural Control Dynamic and Sleep Quality in Soccer Athletes: Randomized Study and Blind
- ClinicalTrials.gov ID
- NCT02806609
- Acronym / sponsor ID
- COLD WATER IMMERSION
- Keywords
- football, cryotherapy, balance, electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 1 Jun 2016
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 20 Jun 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.
Objective: To evaluate the effect of cold water immersion in elayed onset muscle soreness, muscle recruitment, dynamic postural control and quality of sleep in young soccer players.
Methods: The sample will consist of 28 soccer players between 18 and 21 years of the same football club and with the same routine practices and games. At first athletes will respond to the IC and will be submitted to the test of a repetition maximum. After three days the athletes will analysis of muscle recruitment by electromyography and dynamic posture control through the force platform both during the time of shooting, moreover, will respond to scale the quality of sleep the previous night and one on pain, then they are instructed to perform a fatigue protocol for the quadriceps and then will be randomized to one of four intervention groups: cold water immersion, submersion in water at room temperature, or active recovery control. The same APPRAISAL be remade into three new moments, 24, 48 and 72 hours after the fatigue test.
Hypothesis: The variables will be considered: Pain intensity in the quadriceps muscle, quality of sleep the night after intervention protocol, electromyographic analysis of the rectus femoris, vastus medialis oblique and vastus lateralis at the time of shooting, as well as postural control when the shot off.
It is intended to establish the best way of recovery of late quadriceps muscle pain and contribute to the clinical practice of active recovery or rest in young soccer players.
Detailed description
The size and power of the sample was raised with use of sample size calculation, the Power and Sample Size program with a 95% confidence interval, alpha level of 5% and power of 80%, considering the mean and standard deviation of data DOMS study the Effects of Cold Water Immersion after Rugby Training on muscle Power and Biochemical Markers. Thus, the sample was set at 48 volunteers, 12 distributed to each of the four groups.
Participate in the study 28 soccer players, aged between 16 and 21 years, male, with training at least 5 times a week, no complaints of musculoskeletal pain or history of muscle injuries in the past six months, hired a same club with the same demand for training and competitions.
Exclusion criteria will be observed vascular problems, allergy to cold, surgery of the lower limbs in the past six months, athletes in viral states (such as colds or flu).
These will be randomized into four groups: cold water immersion (N = 7) immersion in water at room temperature (n = 7), active recovery (n = 7) and control (N = 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Cold water immersion, with 10 degrees, for 10 minutesCold water immersion, with 10 degrees, for 10 minutes |
| Group 2 | Other | Other: immersion in water at room temperatureimmersion in water at room temperature |
| Group 3 | Other | Other: active recovery - runningactive recovery - running |
| Group 4 | Other | Other: rest in the chairrest in the chair |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Soccer players
- Aged between 16 and 21 years
- Male
- Train at least 5 times a week
- No complaints of musculoskeletal pain or history of muscle injuries in the past six months
Key exclusion criteria (3 listed)
- Allergy to cold
- Surgery of the lower limbs in the past six months
- Athletes in viral states (such as colds or flu)
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, with 10 degrees, for 10 minutescold water immersion | Other | Group 1 |
| immersion in water at room temperatureimmersion in water at room temperature | Other | Group 2 |
| active recovery - runningactive recovery | Other | Group 3 |
| rest in the chairrest in the chair | Other | Group 4 |
Primary outcome
visual pain scale
Time frame: change of pain within 72 hours
Demirhan et al. (2015) showed reduced muscle pain with the application of cold water immersion in elite wrestlers. Visual analogue range, ranging from 0 to 10, where 0 is no pain and 10 is maximum pain.
3 secondary outcomes
balance by force platform
Time frame: before the intervention and 24, 48 and 72 hours, by force platform
muscle recruitment by electromyography
Time frame: before the intervention and 24, 48 and 72 hours, by electromyography
Sleep measured by Visual Analog Scale
Time frame: before the intervention and 24, 48 and 72 hours, by questionnaire
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 19 Dec 2017.
- Background: PubMed 22336838Bleakley C, McDonough S, Gardner E, Baxter GD, Hopkins JT, Davison GW. Cold-water immersion (cryotherapy) for preventing and treating muscle soreness after exercise. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008262. doi: 10.1002/14651858.CD008262.pub2.
- Background: PubMed 19074671Buchheit M, Peiffer JJ, Abbiss CR, Laursen PB. Effect of cold water immersion on postexercise parasympathetic reactivation. Am J Physiol Heart Circ Physiol. 2009 Feb;296(2):H421-7. doi: 10.1152/ajpheart.01017.2008. Epub 2008 Dec 12.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Christiane Macedo, doctor principal investigator
Universidade Estadual de Londrina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold water immersion, with 10 degrees, for 10 minutes, immersion in water at room temperature and active recovery - running in people with Pain and Sleep, run by Universidade Estadual de Londrina 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 6 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: finished, as of the sponsor's last update on 19 Dec 2017. 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?
visual pain scale (time frame: change of pain within 72 hours). 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 NCT02806609, which also lists 2 linked publications.
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 19 Dec 2017.