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Creatine Kinase Levels and Clinical and Functional Parameters in Parajiu-jitsu Athletes

Primary Purpose

Healthy, Deficiency Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
combat fight
Sponsored by
São Paulo State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Healthy

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • withdrawal of participants for personal reasons

Sites / Locations

  • Rayana Loch GomesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group 1 combat fight

group 2 combat fight

Arm Description

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

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

Outcomes

Primary Outcome Measures

creatine kinase
blood collection

Secondary Outcome Measures

perception of recovery
scale
muscle pain
scale

Full Information

First Posted
October 4, 2018
Last Updated
October 5, 2018
Sponsor
São Paulo State University
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1. Study Identification

Unique Protocol Identification Number
NCT03698578
Brief Title
Creatine Kinase Levels and Clinical and Functional Parameters in Parajiu-jitsu Athletes
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
February 20, 2019 (Anticipated)
Study Completion Date
March 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
São Paulo State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Deficiency Diseases

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1 combat fight
Arm Type
Experimental
Arm Description
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
Arm Title
group 2 combat fight
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
combat fight
Intervention Description
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
Primary Outcome Measure Information:
Title
creatine kinase
Description
blood collection
Time Frame
post fight - 72 hours
Secondary Outcome Measure Information:
Title
perception of recovery
Description
scale
Time Frame
post fight - 72 hours
Title
muscle pain
Description
scale
Time Frame
post fight - 72 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: withdrawal of participants for personal reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaqueline Lopes, master
Phone
66999202206
Email
jaqueee-santosss@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aryane Machado, master
Phone
18 981156556
Ext
+ 55
Email
ary_machado@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Michelletti, master
Organizational Affiliation
Paulista State University
Official's Role
Study Chair
Facility Information:
Facility Name
Rayana Loch Gomes
City
Barra do Garças
State/Province
Mount
ZIP/Postal Code
78600-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaqueline Lopes
Phone
66999202206
Email
jaqueee-santosss@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Creatine Kinase Levels and Clinical and Functional Parameters in Parajiu-jitsu Athletes

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