SoccerNCT03593733
Comparison Between Photobiomodulation Therapy (PBMT) and a Cold-Water Immersion (CWI) in Recovery Soccer Player: Analysis of Biochemical Markers of Recovery and Muscular Oxidative Stress.
A study testing Photobiomodulation Therapy and Cold Water Immersion in people with Soccer and Fatigue, run by LUCIANA MARIA MALOSA SAMPAIO.
Trial summary
Competitive soccer engages many of the body's systems to a major extent. The musculoskeletal, nervous, immune and metabolic systems are stressed to a point where recovery strategies post-exercise become influential in preparing for the next match. Read more about this study
- Who is it for?
- Ages 16 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Soccer, Fatigue, Oxidative Stress
- What is being tested?
- Photobiomodulation Therapy and Cold Water Immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2019
- 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 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- No soccer playres.
About this study
Competitive soccer engages many of the body's systems to a major extent. The musculoskeletal, nervous, immune and metabolic systems are stressed to a point where recovery strategies post-exercise become influential in preparing for the next match.
Recovery from exercise can be an important factor in performance during repeated bouts of exercise. In a tournament situation, where athletes may compete numerous times over a few days, enhancing recovery may provide a competitive advantage. Recent work has highlighted that the aim of most recovery interventions is to return psychological, physiological, and performance variables to the 'pre-exercise' level or to baseline conditions identified in the absence of fatigue.
Read more
The post-exercise cold water immersion (CWI) through its primary ability to decrease tissue temperature and blood flow, is purported to facilitate recovery by ameliorating hyperthermia and subsequent alterations to the central nervous system (CNS), reducing cardiovascular strain, removing accumulated muscle metabolic by-products, attenuating exercise-induced muscle damage (EIMD) and improving autonomic nervous system function. All these alterations provoke important physiological changes for the recovery of the athlete.
Scientific evidence for other strategies reviewed in their ability to accelerate the return to the initial level of performance is still lacking. These include active recovery, stretching, compression garments, massage and electrical stimulation. While this does not mean that these strategies do not aid the recovery process, the protocols implemented up until now do not significantly accelerate the return to initial levels of performance in comparison with a control condition.
Among these new strategies, Photobimodulation therapy - PBMT using low-level laser therapy (LLLT) and light-emitting diode therapy (LEDT) has been the focus of important research insights science in recent years. The PBMT has been used to increase muscle performance and reduces muscle fatigue signals. The mechanism proposed for the use of PBMT in sports and exercise is the increase in cytochrome c-oxidase in skeletal muscle fibers that lead to upregulation of mitochondrial activity, which increases ATP production promoting more energy for the muscle and decreases oxidative stress and reactive oxygen species production.
Considering that the consented CWI is already used with good results in soccer athletes, however it has some drawbacks such as the time of application and the inconvenience caused by the application of cold and the new possibilities presented in the literature of the use of PBMT we propose to carry out this study. To address these issues, the present study aims to investigate and analyze biological markers on oxidative stress and muscle damage in soccer athletes after a match submitted to recovery strategies through CWI and PBMT
Read the detailed description
In elite soccer, players are frequently required to play consecutive matches interspersed by 3 days and complete physical performance recovery may not be achieved. Incomplete recovery might result in underperformance and injury. During congested schedules, recovery strategies are therefore required to alleviate post-match fatigue, regain performance faster and reduce the risk of injury. Recovery from exercise can be an important factor in performance during repeated bouts of exercise.
The strenuous exercise induces muscle cell structural damage, which results in increased plasma concentrations of muscle enzymes such as CK and LDH. The efflux of CK and LDH proteins from muscle may be attributed to increased permeability of the plasma membrane or intramuscular vasculature (or both). Thus, a reduction in these markers has been proposed as an indicator of recovery after strenuous exercise that induces muscle damage.
- Conditions
- Soccer, Fatigue, Oxidative Stress, Recovery, Cold Water Immersion, Photobiomodulation Therapy
- Being tested
- Photobiomodulation Therapy, Cold Water Immersion
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyOther
Also called Cold Water Immersion
Photobiomodulation Therapy
Cold Water ImmersionOther
Cold Water Immersion
| Study group | Role | What they receive |
|---|---|---|
| Cold Water Immersion | Experimental | Cold Water Immersion Receives: Other: Cold Water Immersion |
| Photobiomodulation Therapy | Experimental | Photobiomodulation Therapy Receives: Other: Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of Creatine Kinase (CK) activity
Sample of Blood
Measured: Baseline; immediatily soccer match and 48 hours after.
Serum levels Thiobarbituric acid reactive substances -TBARS
Sample of Blood
Measured: Baseline; immediatily soccer match and 48 hours after.
Serum levels Superoxide Dismutase -SOD
Sample of Blood
Measured: Baseline; immediatily soccer match and 48 hours after.
Serum levels Catalase - CAT
Sample of Blood
Measured: Baseline; immediatily soccer match and 48 hours after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study startJan 2017
- Primary completionAug 2017
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SoccerStudies 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
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- LUCIANA MARIA MALOSA SAMPAIO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho
- Investigators
- Paulo de Tarso Camillo de Carvalho, Professor, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593733
- Sponsor's protocol ID
- PBTM CWI
- Status last verified
- May 2024
- First submitted
- 25 Jun 2018
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Versey NG, Halson SL, Dawson BT. Water immersion recovery for athletes: effect on exercise performance and practical recommendations. Sports Med. 2013 Nov;43(11):1101-30. doi: 10.1007/s40279-013-0063-8.
PubMed 23743793Ihsan M, Watson G, Abbiss CR. What are the Physiological Mechanisms for Post-Exercise Cold Water Immersion in the Recovery from Prolonged Endurance and Intermittent Exercise? Sports Med. 2016 Aug;46(8):1095-109. doi: 10.1007/s40279-016-0483-3.
PubMed 26888646Nedelec M, McCall A, Carling C, Legall F, Berthoin S, Dupont G. Recovery in soccer : part ii-recovery strategies. Sports Med. 2013 Jan;43(1):9-22. doi: 10.1007/s40279-012-0002-0.
PubMed 23315753Vanin AA, Verhagen E, Barboza SD, Costa LOP, Leal-Junior ECP. Photobiomodulation therapy for the improvement of muscular performance and reduction of muscular fatigue associated with exercise in healthy people: a systematic review and meta-analysis. Lasers Med Sci. 2018 Jan;33(1):181-214. doi: 10.1007/s10103-017-2368-6. Epub 2017 Oct 31.
PubMed 29090398de Oliveira AR, Vanin AA, Tomazoni SS, Miranda EF, Albuquerque-Pontes GM, De Marchi T, Dos Santos Grandinetti V, de Paiva PRV, Imperatori TBG, de Carvalho PTC, Bjordal JM, Leal-Junior ECP. Pre-Exercise Infrared Photobiomodulation Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans: What Is the Optimal Power Output? Photomed Laser Surg. 2017 Nov;35(11):595-603. doi: 10.1089/pho.2017.4343.
PubMed 29099680De Marchi T, Schmitt VM, Machado GP, de Sene JS, de Col CD, Tairova O, Salvador M, Leal-Junior EC. Does photobiomodulation therapy is better than cryotherapy in muscle recovery after a high-intensity exercise? A randomized, double-blind, placebo-controlled clinical trial. Lasers Med Sci. 2017 Feb;32(2):429-437. doi: 10.1007/s10103-016-2139-9. Epub 2017 Jan 5.
PubMed 28054262Reilly T, Ekblom B. The use of recovery methods post-exercise. J Sports Sci. 2005 Jun;23(6):619-27. doi: 10.1080/02640410400021302.
PubMed 16195010Nedelec M, McCall A, Carling C, Legall F, Berthoin S, Dupont G. Recovery in soccer: part I - post-match fatigue and time course of recovery. Sports Med. 2012 Dec 1;42(12):997-1015. doi: 10.2165/11635270-000000000-00000.
PubMed 23046224Wilcock IM, Cronin JB, Hing WA. Physiological response to water immersion: a method for sport recovery? Sports Med. 2006;36(9):747-65. doi: 10.2165/00007256-200636090-00003.
PubMed 16937951Murray A, Cardinale M. Cold applications for recovery in adolescent athletes: a systematic review and meta analysis. Extrem Physiol Med. 2015 Oct 12;4:17. doi: 10.1186/s13728-015-0035-8. eCollection 2015.
PubMed 26464795
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Photobiomodulation Therapy (PBMT) and a Cold-Water Immersion (CWI) in Recovery Soccer Player: Analysis of Biochemical Markers of Recovery and Muscular Oxidative Stress.
- ClinicalTrials.gov ID
- NCT03593733
- Acronym / sponsor ID
- PBTM CWI
- Conditions
- Soccer, Fatigue, Oxidative Stress, Recovery, Cold Water Immersion, Photobiomodulation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- LUCIANA MARIA MALOSA SAMPAIOUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 20 Jul 2018 (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.
Competitive soccer engages many of the body's systems to a major extent. The musculoskeletal, nervous, immune and metabolic systems are stressed to a point where recovery strategies post-exercise become influential in preparing for the next match.
Recovery from exercise can be an important factor in performance during repeated bouts of exercise. In a tournament situation, where athletes may compete numerous times over a few days, enhancing recovery may provide a competitive advantage. Recent work has highlighted that the aim of most recovery interventions is to return psychological, physiological, and performance variables to the 'pre-exercise' level or to baseline conditions identified in the absence of fatigue.
The post-exercise cold water immersion (CWI) through its primary ability to decrease tissue temperature and blood flow, is purported to facilitate recovery by ameliorating hyperthermia and subsequent alterations to the central nervous system (CNS), reducing cardiovascular strain, removing accumulated muscle metabolic by-products, attenuating exercise-induced muscle damage (EIMD) and improving autonomic nervous system function. All these alterations provoke important physiological changes for the recovery of the athlete.
Scientific evidence for other strategies reviewed in their ability to accelerate the return to the initial level of performance is still lacking. These include active recovery, stretching, compression garments, massage and electrical stimulation. While this does not mean that these strategies do not aid the recovery process, the protocols implemented up until now do not significantly accelerate the return to initial levels of performance in comparison with a control condition.
Among these new strategies, Photobimodulation therapy - PBMT using low-level laser therapy (LLLT) and light-emitting diode therapy (LEDT) has been the focus of important research insights science in recent years. The PBMT has been used to increase muscle performance and reduces muscle fatigue signals. The mechanism proposed for the use of PBMT in sports and exercise is the increase in cytochrome c-oxidase in skeletal muscle fibers that lead to upregulation of mitochondrial activity, which increases ATP production promoting more energy for the muscle and decreases oxidative stress and reactive oxygen species production.
Considering that the consented CWI is already used with good results in soccer athletes, however it has some drawbacks such as the time of application and the inconvenience caused by the application of cold and the new possibilities presented in the literature of the use of PBMT we propose to carry out this study. To address these issues, the present study aims to investigate and analyze biological markers on oxidative stress and muscle damage in soccer athletes after a match submitted to recovery strategies through CWI and PBMT
Detailed description
In elite soccer, players are frequently required to play consecutive matches interspersed by 3 days and complete physical performance recovery may not be achieved. Incomplete recovery might result in underperformance and injury. During congested schedules, recovery strategies are therefore required to alleviate post-match fatigue, regain performance faster and reduce the risk of injury. Recovery from exercise can be an important factor in performance during repeated bouts of exercise.
The strenuous exercise induces muscle cell structural damage, which results in increased plasma concentrations of muscle enzymes such as CK and LDH. The efflux of CK and LDH proteins from muscle may be attributed to increased permeability of the plasma membrane or intramuscular vasculature (or both). Thus, a reduction in these markers has been proposed as an indicator of recovery after strenuous exercise that induces muscle damage.
Study design
- Primary purpose
- Treatment
- 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 ImmersionCold Water Immersion |
| Photobiomodulation Therapy | Experimental | Other: Photobiomodulation TherapyPhotobiomodulation Therapy |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- No soccer playres.
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 |
|---|---|---|
| Photobiomodulation TherapyAlso: Cold Water ImmersionPhotobiomodulation Therapy | Other | Photobiomodulation Therapy |
| Cold Water ImmersionCold Water Immersion | Other | Cold Water Immersion |
Primary outcome
Serum levels of Creatine Kinase (CK) activity
Time frame: Baseline; immediatily soccer match and 48 hours after.
Sample of Blood
Serum levels Thiobarbituric acid reactive substances -TBARS
Time frame: Baseline; immediatily soccer match and 48 hours after.
Sample of Blood
Serum levels Superoxide Dismutase -SOD
Time frame: Baseline; immediatily soccer match and 48 hours after.
Sample of Blood
Serum levels Catalase - CAT
Time frame: Baseline; immediatily soccer match and 48 hours after.
Sample of Blood
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 7 May 2024.
- Background: PubMed 23743793Versey NG, Halson SL, Dawson BT. Water immersion recovery for athletes: effect on exercise performance and practical recommendations. Sports Med. 2013 Nov;43(11):1101-30. doi: 10.1007/s40279-013-0063-8.
- Background: PubMed 26888646Ihsan M, Watson G, Abbiss CR. What are the Physiological Mechanisms for Post-Exercise Cold Water Immersion in the Recovery from Prolonged Endurance and Intermittent Exercise? Sports Med. 2016 Aug;46(8):1095-109. doi: 10.1007/s40279-016-0483-3.
- Background: PubMed 23315753Nedelec M, McCall A, Carling C, Legall F, Berthoin S, Dupont G. Recovery in soccer : part ii-recovery strategies. Sports Med. 2013 Jan;43(1):9-22. doi: 10.1007/s40279-012-0002-0.
- Background: PubMed 29090398Vanin AA, Verhagen E, Barboza SD, Costa LOP, Leal-Junior ECP. Photobiomodulation therapy for the improvement of muscular performance and reduction of muscular fatigue associated with exercise in healthy people: a systematic review and meta-analysis. Lasers Med Sci. 2018 Jan;33(1):181-214. doi: 10.1007/s10103-017-2368-6. Epub 2017 Oct 31.
- Background: PubMed 29099680de Oliveira AR, Vanin AA, Tomazoni SS, Miranda EF, Albuquerque-Pontes GM, De Marchi T, Dos Santos Grandinetti V, de Paiva PRV, Imperatori TBG, de Carvalho PTC, Bjordal JM, Leal-Junior ECP. Pre-Exercise Infrared Photobiomodulation Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans: What Is the Optimal Power Output? Photomed Laser Surg. 2017 Nov;35(11):595-603. doi: 10.1089/pho.2017.4343.
- Background: PubMed 28054262De Marchi T, Schmitt VM, Machado GP, de Sene JS, de Col CD, Tairova O, Salvador M, Leal-Junior EC. Does photobiomodulation therapy is better than cryotherapy in muscle recovery after a high-intensity exercise? A randomized, double-blind, placebo-controlled clinical trial. Lasers Med Sci. 2017 Feb;32(2):429-437. doi: 10.1007/s10103-016-2139-9. Epub 2017 Jan 5.
- Results publication: PubMed 16195010Reilly T, Ekblom B. The use of recovery methods post-exercise. J Sports Sci. 2005 Jun;23(6):619-27. doi: 10.1080/02640410400021302.
- Results publication: PubMed 23046224Nedelec M, McCall A, Carling C, Legall F, Berthoin S, Dupont G. Recovery in soccer: part I - post-match fatigue and time course of recovery. Sports Med. 2012 Dec 1;42(12):997-1015. doi: 10.2165/11635270-000000000-00000.
- Results publication: PubMed 16937951Wilcock IM, Cronin JB, Hing WA. Physiological response to water immersion: a method for sport recovery? Sports Med. 2006;36(9):747-65. doi: 10.2165/00007256-200636090-00003.
- Results publication: PubMed 26464795Murray A, Cardinale M. Cold applications for recovery in adolescent athletes: a systematic review and meta analysis. Extrem Physiol Med. 2015 Oct 12;4:17. doi: 10.1186/s13728-015-0035-8. eCollection 2015.
- Individual participant dataSharing planned: Undecided
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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.
Paulo de Tarso Camillo de Carvalho, Professor principal investigator
University of Nove de Julho
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation Therapy and Cold Water Immersion in people with Soccer and Fatigue, run by LUCIANA MARIA MALOSA SAMPAIO.
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 0 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 7 May 2024. 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?
Serum levels of Creatine Kinase (CK) activity (time frame: Baseline; immediatily soccer match and 48 hours after.). The study lists 4 primary outcomes in all. 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 NCT03593733, which also lists 10 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 7 May 2024.