Clinical trial NCT04841876: Sports-related Concussion: Physiological, Biomechanical and Cognitive Methodology
Official title: Sports-related Concussion: Physiological, Biomechanical and Cognitive Methodology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Concussion (Diagnosis)
Keywords: Blood-based biomarkers
Motor control
Cognitive function Skill
Biomechanics
Sport-related concussion
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be the professional rugby-7s players at the Hong Kong Sports Institute (Sha Tin, N.T. Hong Kong, China).

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.

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.

Primary outcomes:
measure: Change in blood indicator
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches, and 24-, 48-, and 72-hours post-match
measure: Change in biomechanical performance: Throwing task
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches
measure: Change in biomechanical performance: mBESS
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches
measure: Change in biomechanical performance: Tandem Gait
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches.
measure: Change in biomechanical performance: Finger-to-nose
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches.
measure: Change in cognitive-motor performance: Purdue Pegboard
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches.
measure: Change in cognitive-motor performance: Tapping Task
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches.
measure: Change in cognitive-motor performance: Stroop word test
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches.
measure: Change in cognitive-motor performance: Reaction time
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches.
measure: Change in cognitive-motor performance: Working memory
timeFrame: Data will be collected at pre-match, and after each of 3 consecutive matches.
Secondary outcomes:
measure: Demographics and anthropometrics
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Baptist University
name: Julien S. Baker, Ph.D., D.Sc.
role: PRINCIPAL_INVESTIGATOR
References: