HealthyNCT03698578
Creatine Kinase Levels and Clinical and Functional Parameters in Parajiu-jitsu Athletes
A study testing combat fight in people with Healthy and Deficiency Diseases, run by São Paulo State University at 1 site in Brazil.
Trial summary
Introduction: Evidence indicates that muscle damage caused by exercise can lead to functional, biochemical and clinical damage. Therefore, it is pertinent to perform investigations related to the muscle damage marker, creatine kinase with clinical and functional responses. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Deficiency Diseases
- What is being tested?
- combat fight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2018to 20 Mar 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Jiu-Jitsu paratroopers were included. To be included in the study participants should report absence of anemia, inflammation, diabetes, cardiovascular disease, and musculoskeletal injuries in the six months prior to data collection. In addition, participants were instructed to refrain from anti-inflammatory drugs, analgesics, alcoholic beverages, and tobacco and did not perform any extra exercise during the study.
Who cannot join
- withdrawal of participants for personal reasons
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rayana Loch Gomes
Barra do Garças, Mount, 78600-000
Jaqueline Lopes, 66999202206, jaqueee-santosss@hotmail.com
About this study
Official title: Correlation Between Creatine Kinase Levels and Clinical and Functional Parameters in the Moments Following the Fight in Parajiu-jitsu Athletes: A Controlled Clinical Trial
Introduction: Evidence indicates that muscle damage caused by exercise can lead to functional, biochemical and clinical damage. Therefore, it is pertinent to perform investigations related to the muscle damage marker, creatine kinase with clinical and functional responses. These outcomes encompass an intrinsic potential for understanding the real magnitude of interpretation of classic signals in athletic environments and monitoring of athletes, contributing to specific actions. Objective: To verify the correlation between clinical signs (pain and perception of recovery), functional (muscular strength) and the behavior of CK levels, in the moments following a simulated fight. METHODS: Six male parajiu-jitsu practitioners (34-44 years) were included in the study. The participants attended the collection site 4 times, with a 24-hour interval between sessions, characterizing the following collection moments: baseline, post-exertion, 24, 48 and 72 hours after the simulated fight. Data on pain (visual analogue scale - EVA), perception of recovery (Likert Scale), muscle strength (Dynamometry) and blood samples for CK analysis were collected. All parameters described were measured at all times of collection. For the analysis of the association between behavior of CK levels, clinical and functional variables, the Odds Ratio test and 95% confidence interval were used. For the gross values, the Pearson test was used according to the normality of the data.
Read the detailed description
Participants will be intentionally allocated into two groups, G1 consisting of professional athletes and G2 consisting of amateur athletes. This division was carried out to guarantee homogeneous stratification between participants with level of conditioning and similar training. The anonymity of the participants will be guaranteed. There will be masking of the participants, investigator and evaluator of the results that were blind to the hypotheses and allocation in groups, adopted in the study. All participants regularly attended the same training center and no sports injuries that might compromise athletic performance will be reported during the survey.
- Conditions
- Healthy, Deficiency Diseases
- Being tested
- combat fight
- Medical subject headings
- Deficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combat fightOther
Jiu-jitsu heating with light intensity was used for 5 minutes. The simulated fight protocol occurred in accordance with the rules of the Brazilian Confederation of Sports Jiu-Jitsu, excluding any types of finalization. In these cases, the athletes were separated and oriented to return immediately. Thus, maximum effort was advocated as well as, similar time of activity for all
| Study group | Role | What they receive |
|---|---|---|
| group 1 combat fight | Experimental | Consisting of professional, high-performance paratletas. Intervention: Jiu-jitsu heating with light intensity was used for 5 minutes. The simulated fight protocol occurred in accordance with the rules of the Brazilian Confederation of Sports Jiu-Jitsu, excluding any types of finalization. In these cases, the athletes were separated and oriented to return immediately. Thus, maximum effort was advocated as well as, similar time of activity for all Receives: Other: combat fight |
| group 2 combat fight | Experimental | Constituted by amateur paratroopers. Intervention: Jiu-jitsu heating with light intensity was used for 5 minutes. The simulated fight protocol occurred in accordance with the rules of the Brazilian Confederation of Sports Jiu-Jitsu, excluding any types of finalization. In these cases, the athletes were separated and oriented to return immediately. Thus, maximum effort was advocated as well as, similar time of activity for all Receives: Other: combat fight |
What is being measured
The primary outcome is the main question the study is designed to answer.
creatine kinase
blood collection
Measured: post fight - 72 hours
Secondary outcomes (2)
perception of recovery
scale
Measured: post fight - 72 hours
muscle pain
scale
Measured: post fight - 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start20 Sep 2018
- Primary completion20 Feb 2019 (estimated)
- Study completion20 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaqueline Santos Silva, São Paulo State University
- Investigators
- Jessica Michelletti, master, Study chair, Paulista State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698578
- Sponsor's protocol ID
- SaoPSU_UFMT1
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Creatine Kinase Levels and Clinical and Functional Parameters in the Moments Following the Fight in Parajiu-jitsu Athletes: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03698578
- Acronym / sponsor ID
- SaoPSU_UFMT1
- Conditions
- Healthy, Deficiency Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 20 Feb 2019 (estimated)
- Study completion
- 20 Mar 2019 (estimated)
- First posted
- 9 Oct 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.
Introduction: Evidence indicates that muscle damage caused by exercise can lead to functional, biochemical and clinical damage. Therefore, it is pertinent to perform investigations related to the muscle damage marker, creatine kinase with clinical and functional responses. These outcomes encompass an intrinsic potential for understanding the real magnitude of interpretation of classic signals in athletic environments and monitoring of athletes, contributing to specific actions. Objective: To verify the correlation between clinical signs (pain and perception of recovery), functional (muscular strength) and the behavior of CK levels, in the moments following a simulated fight. METHODS: Six male parajiu-jitsu practitioners (34-44 years) were included in the study. The participants attended the collection site 4 times, with a 24-hour interval between sessions, characterizing the following collection moments: baseline, post-exertion, 24, 48 and 72 hours after the simulated fight. Data on pain (visual analogue scale - EVA), perception of recovery (Likert Scale), muscle strength (Dynamometry) and blood samples for CK analysis were collected. All parameters described were measured at all times of collection. For the analysis of the association between behavior of CK levels, clinical and functional variables, the Odds Ratio test and 95% confidence interval were used. For the gross values, the Pearson test was used according to the normality of the data.
Detailed description
Participants will be intentionally allocated into two groups, G1 consisting of professional athletes and G2 consisting of amateur athletes. This division was carried out to guarantee homogeneous stratification between participants with level of conditioning and similar training. The anonymity of the participants will be guaranteed. There will be masking of the participants, investigator and evaluator of the results that were blind to the hypotheses and allocation in groups, adopted in the study. All participants regularly attended the same training center and no sports injuries that might compromise athletic performance will be reported during the survey.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 combat fight | Experimental | Other: combat fightConsisting of professional, high-performance paratletas. Intervention: Jiu-jitsu heating with light intensity was used for 5 minutes. The simulated fight protocol occurred in accordance with the rules of the Brazilian Confederation of Sports Jiu-Jitsu, excluding any types of finalization. In these cases, the athletes were separated and oriented to return immediately. Thus, maximum effort was advocated as well as, similar time of activity for all |
| group 2 combat fight | Experimental | Other: combat fightConstituted by amateur paratroopers. Intervention: Jiu-jitsu heating with light intensity was used for 5 minutes. The simulated fight protocol occurred in accordance with the rules of the Brazilian Confederation of Sports Jiu-Jitsu, excluding any types of finalization. In these cases, the athletes were separated and oriented to return immediately. Thus, maximum effort was advocated as well as, similar time of activity for all |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Jiu-Jitsu paratroopers were included. To be included in the study participants should report absence of anemia, inflammation, diabetes, cardiovascular disease, and musculoskeletal injuries in the six months prior to data collection. In addition, participants were instructed to refrain from anti-inflammatory drugs, analgesics, alcoholic beverages, and tobacco and did not perform any extra exercise during the study.
Key exclusion criteria (1 listed)
- withdrawal of participants for personal reasons
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 |
|---|---|---|
| combat fightJiu-jitsu heating with light intensity was used for 5 minutes. The simulated fight protocol occurred in accordance with the rules of the Brazilian Confederation of Sports Jiu-Jitsu, excluding any types of finalization. In these cases, the athletes were separated and oriented to return immediately. Thus, maximum effort was advocated as well as, similar time of activity for all | Other | group 1 combat fight, group 2 combat fight |
Primary outcome
creatine kinase
Time frame: post fight - 72 hours
blood collection
2 secondary outcomes
perception of recovery
Time frame: post fight - 72 hours
muscle pain
Time frame: post fight - 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Jessica Michelletti, master study chair
Paulista State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combat fight in people with Healthy and Deficiency Diseases, run by São Paulo State 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 1 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaqueline Lopes, master (66999202206, jaqueee-santosss@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
creatine kinase (time frame: post fight - 72 hours). 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 9 Oct 2018.