Sports-related Concussion: Physiological, Biomechanical and Cognitive Methodology

NCT ID: NCT04841876

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-06-30

Brief Summary

The study aims to investigate the changes in physiological, biomechanical and cognitive performance under a traumatic sport-event (i.e., rugby match).

Detailed Description

Background: Regular participation in moderate-to-vigorous physical activity in contact sports may be related to increases in cerebrovascular injury and head trauma. The diagnosis of head injury is lacking in validated objective measures immediate post event. Diagnostic markers may also be confounded by the exercise type and intensity. Therefore, it deserves further examination on a variety of functional (biomechanical and motor control) performance and blood-based biomarkers to determine how these indicators are affected by contact sport and the incidence of head injury. The study aims to investigate the changes in physiological, biomechanical and cognitive performance under a traumatic sport-event.

Methods: The study will use a two-group randomized controlled trial (RCT) with double-blinded approach, comprising a traumatic sport-event group and a control group. Thirty rugby-7s players will be recruited and randomly assigned to one of the two groups, where the intervention group will play three consecutive rugby matches. Data will be collected pre and post rugby match performance. Particularly, demographic and anthropometric data will be collected at baseline and pre-match. Venous blood, biomechanical data, and cognitive-motor task data will be collected at baseline, pre-match, and after each of 3 consecutive matches. Notational analysis will be performed after each match. Venous blood will be collected 24, 48, and 72 hours after the 3rd match.

Discussion: It is expected to see a reduction in whole-body movement, coordination, and cognitive-motor tasks as the number of games continues through fatigue and/or traumatic events. It is also expected that changes in blood-based biomarker concentrations to correlate with changes in biomechanical and cognitive-motor tasks. The proposed study will yield meaningful, ecologically valid research regarding the occurrence of concussive events, the influence of these on the biological system of the performer, with direct impact on clinicians, scientists, and sport governing bodies. The scope of this study will have implications on health and wellbeing within sporting populations at all levels, genders, and ages. Additionally, the findings will facilitate greater understanding about the human responses to exercise induced trauma.

Conditions

Concussion (Diagnosis)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group-1

Participants who are professional rugby-7s plays will be randomly assigned to one of the two groups. For Group-1, participants will be asked to play three consecutive rugby matches, with 40 min for each match. The total duration will be 2 hours. There is no additional intervention on this group.

rugby matches

Intervention Type: OTHER

standard rugby-7s match

Group 2

Participants who are professional rugby-7s plays will be randomly assigned to one of the two groups. For Group-2, participants will be asked to only watch the rugby matches. They will not received any intervention.

No interventions assigned to this group

Interventions

rugby matches

standard rugby-7s match

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

(1) Participants should be 18 years old or above; (2) no restriction of physical mobility; (3) no uncontrollable mental disorders; and (4) professional rugby-7s player.

Exclusion Criteria

(1) less than 18 years old; (2) have restriction of physical mobility; (3) have uncontrollable mental disorders; and (4) training duration of rugby is less than one year.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

Prof Baker Julien

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julien S. Baker, Ph.D., D.Sc.

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Central Contacts

Julien S. Baker, Ph.D., D.Sc.

Role: CONTACT

jsbaker@hkbu.edu.hk

+852-34118032

Other Identifiers

REC/20-21/0452

Identifier Type: -

Identifier Source: org_study_id