NCT05909592

Brief Summary

CrossFit is a modern sport, introduced to the public in 2000 and popular quickly with more than 15,000 affiliates worldwide. Due to the highly demanding nature of the workouts, it is claimed to be a sport with a high prevalence of injuries. Most preliminary retrospective studies had shown that shoulder area is injured most frequently, at about a quarter of all injuries. Therefore, the initial goal of this observational (prospective cohort) study is to learn about the incidence rates of shoulder injuries and potential risk factors in a Greek population of CrossFit participants. Based on these results, this study's ultimate purpose is to create a short warm-up program capable of reducing shoulder injuries and evaluate its effectiveness. The main questions it aims to answer are:

  • Are shoulder injuries as frequent as previous studies have shown to be?
  • Can we blame for these injuries a previous history of musculoskeletal injury or deficits of range of motion, strength, and muscular endurance?
  • Can a short warm up which targets revealed deficiencies be effective in reducing shoulder injuries incidence rates? Participants will be asked to:
  • take part in baseline measurements (personal data, previous musculoskeletal history, shoulder and core range of motion, shoulder and hip muscle strength, shoulder stabilizers endurance, functional assessment sport-specific tests)
  • be monitored for new shoulder injuries or aggravation of old shoulder injuries that will occur during 12 months following baseline measurements. In this case, they must refer it to their coaches to be contacted and assessed by the researcher.
  • be in touch with the researcher throughout the observational study and provide any required data regarding their participation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

May 1, 2023

Last Update Submit

February 2, 2025

Conditions

Keywords

Sports InjuryShoulder InjuriesRisk FactorsInjury PreventionInjury PredictionMachine LearningCrossFit

Outcome Measures

Primary Outcomes (16)

  • BMI

    Weight (kg) and Height (cm) data will be collected to report BMI in kg/m\^2

    Baseline assessment

  • Demographic, general history and shoulder injuries history, activity and experience level

    Participant profile will be formed using an especially designed questionnaire, data will be collected regarding the age, upper limb dominance, months of experience, training volume in hours per week, level of competition, warm up and recovery routines adequacy, details of previous injuries and current situation of shoulder functionality.

    Baseline assessment

  • Core rotation active range of motion

    Right and left core rotation will be measured in degrees utilizing a digital goniometer (HALO digital goniometer, HALO Medical Devices) which has affixed on an aluminum stick. Participant will be holding the stick by hands at the level of scapulas spines and starting rotate his or her core to right and then left direction.

    Baseline assessment

  • Shoulder active range of motion symmetries

    Comparative measurements among shoulders. In an upright position, knees forward and flexed as far as it will be needed in order back and lower back to be attached on the wall, participant will move his/her shoulders toward flexion while maintaining the initial position on the wall. When movement will reach the end point of the available range of motion, the researcher will measure the distances between each wrist and the wall using a measuring tape. The distance may be symmetrical otherwise the shoulder of the upper limb with the bigger distance will be documented as deficient. Same procedure in the same body position will be followed for external and internal rotation of the shoulders but movements will be performed with 90 degrees of shoulder abduction and 90 degrees of elbow flexion.

    Baseline assessment

  • Shoulder stabilizers muscle strength

    Maximal strength of each shoulder external and internal rotators will be measured in kilograms of resistance utilizing a handheld digital dynamometer, K-Force Muscle Controller, via K-Force Pro application reporting (Kinvent, Montpellier, France)

    Baseline assessment

  • Lateral differences in muscle strength between shoulders

    The percentage of lateral differences in maximal strength of internal and external rotation between shoulders will be measured utilizing a handheld digital dynamometer, K-Force Muscle Controller, via K-Force Pro application reporting (Kinvent, Montpellier, France)

    Baseline assessment

  • Hip abductors muscle strength

    Maximal strength of each hip abductors muscles will be measured in kilograms of resistance with the use of a handheld digital dynamometer, K-Force Muscle Controller, via K-Force application reporting (Kinvent, Montpellier, France)

    Baseline assessment

  • Lateral differences in hip abductors strength

    The percentage of lateral differences in maximal strength of abduction between hips will be measured utilizing a handheld digital dynamometer, K-Force Muscle Controller, via K-Force Pro application reporting (Kinvent, Montpellier, France)

    Baseline assessment

  • Muscular endurance of shoulder external rotators

    Using the aforementioned dynamometer application, participants will be asked to do 3 sets of 30 seconds isometric hold at the 60% of the maximal previously produced strength by external rotators muscles (outcome 5). 5 seconds rest between sets will be used. The percentage of the time, on which participants can produce the requested amount of power, will be recorded. This measurement will reflect the endurance capability of this muscle group for each shoulder. Measurement data will be collected using a handheld digital dynamometer, K-Force Muscle Controller, via K-Force Pro application reporting (Kinvent, Montpellier, France).

    Baseline assessment

  • Lateral differences in shoulder external rotators endurance

    The percentage of lateral differences in external rotation isometric hold between right and left side will be exported from K-Force Pro application reporting.

    Baseline assessment

  • Shoulder stability

    Closed Kinetic Chain Upper Extremity Stability test (CKCUES) will be performed to evaluate shoulder stability.

    Baseline assessment

  • CrossFit-specific functional parameters (flexibility, stability, power) using an innovative evaluation tool: CrossFit Functional Assessment Battery for Shoulder (CrossFit FABS)

    Flexibility, stability and power will be evaluated using an innovative assessment tool which was developed especially for the purpose of the present research. CrossFit FABS (Functional Assessment Battery for Shoulder) is a CrossFit-specific, functional evaluation battery in regard to shoulder injury risks. It is composed of 6 tests which resulted from a wider tool through applied pilot research: deep air squat, shoulder mobility, upper frontal kinetic chain flexibility, overhead squat facing wall, windmill with kettlebell and sots press. Each test is scored from 0 to 3, using a 3-point scoring scale with a maximum total score of 18 points.

    Baseline assessment

  • Shoulder injury incidents

    Any new or aggravated pre-existing shoulder injury that will be responsible for at least 1-day training or game loss or training modification to avoid specific high-impact exercises will be recorded. Also, the whole progression of the recovery until return-to-sport will be monitored.

    Up to 12 months

  • Shoulder injury characteristics

    Injury profile will be formed using an especially designed objective and subjective assessment questionnaire, including present injury history, correlation with performed exercise, symptoms, observation abnormalities and special diagnostic tests for shoulder pain (clinical assessment). Exact kind of injury will be determined by the researcher.

    Up to 12 months

  • Disability of injured participants

    A self-reported questionnaire for shoulder, the SDQ (Shoulder Disability Questionnaire), will be filled by injured participants via interview method by the researcher.

    Up to 12 months

  • Pain intensity of injured participants

    VAS pain scale will be used to determine shoulder pain intensity in injured participants.

    Up to 12 months

Secondary Outcomes (2)

  • Shoulder injury risk factors

    After study completion, 2nd year

  • Predictive modeling for shoulder injury incidence in CrossFit

    After study completion, 2nd year

Study Arms (1)

Healthy CrossFit participants and athletes

No intervention. The group will be monitored for incidence data of shoulder injuries (new or aggravated pre-existing)

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

150 (anticipated) healthy individuals who participate in CrossFit. They are training in Crossfit affiliated boxes located at 4 different towns in Greece.

You may qualify if:

  • Healthy adults CrossFit participants of any level of experience
  • Novices who have already completed the trial workouts

You may not qualify if:

  • Injured CrossFit participants who have not yet returned to ordinary training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Patras

Patras, Peloponnese, 26504, Greece

Location

Related Publications (7)

  • Bullock GS, Mylott J, Hughes T, Nicholson KF, Riley RD, Collins GS. Just How Confident Can We Be in Predicting Sports Injuries? A Systematic Review of the Methodological Conduct and Performance of Existing Musculoskeletal Injury Prediction Models in Sport. Sports Med. 2022 Oct;52(10):2469-2482. doi: 10.1007/s40279-022-01698-9. Epub 2022 Jun 11.

    PMID: 35689749BACKGROUND
  • Schwank A, Blazey P, Asker M, Moller M, Hagglund M, Gard S, Skazalski C, Haugsbo Andersson S, Horsley I, Whiteley R, Cools AM, Bizzini M, Ardern CL. 2022 Bern Consensus Statement on Shoulder Injury Prevention, Rehabilitation, and Return to Sport for Athletes at All Participation Levels. J Orthop Sports Phys Ther. 2022 Jan;52(1):11-28. doi: 10.2519/jospt.2022.10952.

    PMID: 34972489BACKGROUND
  • Asker M, Brooke HL, Walden M, Tranaeus U, Johansson F, Skillgate E, Holm LW. Risk factors for, and prevention of, shoulder injuries in overhead sports: a systematic review with best-evidence synthesis. Br J Sports Med. 2018 Oct;52(20):1312-1319. doi: 10.1136/bjsports-2017-098254. Epub 2018 Mar 26.

    PMID: 29581141BACKGROUND
  • Angel Rodriguez M, Garcia-Calleja P, Terrados N, Crespo I, Del Valle M, Olmedillas H. Injury in CrossFit(R): A Systematic Review of Epidemiology and Risk Factors. Phys Sportsmed. 2022 Feb;50(1):3-10. doi: 10.1080/00913847.2020.1864675. Epub 2021 Jan 7.

    PMID: 33322981BACKGROUND
  • Silva ER, Maffulli N, Migliorini F, Santos GM, de Menezes FS, Okubo R. Function, strength, and muscle activation of the shoulder complex in Crossfit practitioners with and without pain: a cross-sectional observational study. J Orthop Surg Res. 2022 Jan 15;17(1):24. doi: 10.1186/s13018-022-02915-x.

    PMID: 35033136BACKGROUND
  • Torres-Banduc MA, Jerez-Mayorga D, Moran J, Keogh JWL, Ramirez-Campillo R. Isokinetic force-power profile of the shoulder joint in males participating in CrossFit training and competing at different levels. PeerJ. 2021 Sep 17;9:e11643. doi: 10.7717/peerj.11643. eCollection 2021.

    PMID: 34616590BACKGROUND
  • Montalvo AM, Shaefer H, Rodriguez B, Li T, Epnere K, Myer GD. Retrospective Injury Epidemiology and Risk Factors for Injury in CrossFit. J Sports Sci Med. 2017 Mar 1;16(1):53-59. eCollection 2017 Mar.

    PMID: 28344451BACKGROUND

MeSH Terms

Conditions

Athletic InjuriesShoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2023

First Posted

June 18, 2023

Study Start

September 24, 2022

Primary Completion

February 12, 2023

Study Completion

February 12, 2024

Last Updated

February 5, 2025

Record last verified: 2025-01

Locations