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Musculoskeletal InjuryNCT05110729

Quality of Life and Life Satisfaction in Pediatric and Adolescent Gymnasts Through Injury

An observational study of Musculoskeletal Injury and Quality of Life, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to assess the quality and life and life satisfaction of pediatric and adolescent gymnasts throughout their musculoskeletal injury recovery. Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Musculoskeletal Injury, Quality of Life
How many people
1,218 participants
Where
1 siteUnited States
Study dates
12 Nov 2021to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Participants will be recruited from Children's Hospital Colorado Sports medicine and Orthopedic outpatient clinics.

Who may be able to join

  • Male and female gymnasts ages 8-18 years old
  • Participating in Excel or Developmental gymnastics programs who present to Children's Hospital Colorado sports medicine or orthopedic clinics with a musculoskeletal injury.

Who cannot join

  • Gymnasts only participating in Colorado Association for Recreational Athletics (CARA) gymnastics, retired gymnasts, and adult or collegiate gymnasts.
  • Vulnerable populations (prisoners, pregnant women, individuals with decreased decision making capacity(

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Casey Little, BS contact

7207770109

casey.little@childrenscolorado.org

United States1 site, 1 recruiting

  • Children's Hospital Colorado

    Denver, Colorado, 80045

    Emily Sweeney, MD, emily.sweeney@childrenscolorado.org

    Recruiting

Other trials in United States

About this study

This study aims to assess the quality and life and life satisfaction of pediatric and adolescent gymnasts throughout their musculoskeletal injury recovery.

Keywords
Gymnastics, Quality of Life and Life Satisfaction
Medical subject headings
Personal Satisfaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-Reported Outcomes Measurement Information System (PROMIS)

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

    Measured: 1 day Initial Visit

  2. Patient-Reported Outcomes Measurement Information System (PROMIS)

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

    Measured: At follow up visit, up to 3 months post initial visit

  3. Patient-Reported Outcomes Measurement Information System (PROMIS)

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

    Measured: 1 day (At clearance visit to return to sport)

  4. Patient-Reported Outcomes Measurement Information System (PROMIS)

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

    Measured: 6-months post initial visit

  5. Patient-Reported Outcomes Measurement Information System (PROMIS)

    A validated questionnaire that quantifies quality of life and life satisfaction in pediatric and adolescent populations.

    Measured: 12-months post initial visit

  6. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    Measured: Assessed at 1 day initial visit

  7. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    Measured: At follow up visit, up to 3 months post initial visit

  8. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    Measured: 1 day (At clearance visit to return to sport)

  9. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    Measured: 6-months post initial visit

  10. Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    Measured: 12-months post initial visit

Secondary outcomes (10)

  1. Injury location and type questionnaire

    Patient-reported details of their musculoskeletal injury, including injury location and type. Also asks for details regarding the participant's pain rating, duration of pain, and the impact the injury has on sport participation.

    Measured: 1 day Initial visit

  2. Level of Specialization

    Questionnaire designed to identify an athlete's level of sport specialization.

    Measured: 1 day (At clearance visit to return to sport)

  3. Level of Specialization

    Questionnaire designed to identify an athlete's level of sport specialization.

    Measured: 6-months post initial visit

  4. Level of Specialization

    Questionnaire designed to identify an athlete's level of sport specialization.

    Measured: 12-months post initial visit

  5. Injury History

    Patient-reported history of previous musculoskeletal injuries.

    Measured: Assessed at the patient's 1 day initial visit.

  6. Pittsburgh Sleep Quality Index (PSQI)

    Questionnaire used to determine the participant's quality of sleep.

    Measured: Assessed at initial 1 day visit

  7. Pittsburgh Sleep Quality Index (PSQI)

    Questionnaire used to determine the participant's quality of sleep.

    Measured: At follow up visit, up to 3 months post initial visit

  8. Pittsburgh Sleep Quality Index (PSQI)

    Questionnaire used to determine the participant's quality of sleep.

    Measured: 1 day (At clearance visit to return to sport)

  9. Pittsburgh Sleep Quality Index (PSQI)

    Questionnaire used to determine the participant's quality of sleep.

    Measured: 6-months post initial visit

  10. Pittsburgh Sleep Quality Index (PSQI)

    Questionnaire used to determine the participant's quality of sleep.

    Measured: 12-months post initial visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2021
  2. Study start12 Nov 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,218 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05110729
Sponsor's protocol ID
21-4271
Status last verified
Apr 2024
First submitted
22 Oct 2021
Last updated
2 Apr 2024
Results posted
No
Individual data sharing
No

Publications

  • Hart E, Meehan WP 3rd, Bae DS, d'Hemecourt P, Stracciolini A. The Young Injured Gymnast: A Literature Review and Discussion. Curr Sports Med Rep. 2018 Nov;17(11):366-375. doi: 10.1249/JSR.0000000000000536.

    PubMed 30407945

  • Beleckas CM, Prather H, Guattery J, Wright M, Kelly M, Calfee RP. Anxiety in the orthopedic patient: using PROMIS to assess mental health. Qual Life Res. 2018 Sep;27(9):2275-2282. doi: 10.1007/s11136-018-1867-7. Epub 2018 May 8.

    PubMed 29740783

  • Lim SW, Shiue YL, Ho CH, Yu SC, Kao PH, Wang JJ, Kuo JR. Anxiety and Depression in Patients with Traumatic Spinal Cord Injury: A Nationwide Population-Based Cohort Study. PLoS One. 2017 Jan 12;12(1):e0169623. doi: 10.1371/journal.pone.0169623. eCollection 2017.

    PubMed 28081205

  • Mainwaring LM, Hutchison M, Bisschop SM, Comper P, Richards DW. Emotional response to sport concussion compared to ACL injury. Brain Inj. 2010;24(4):589-97. doi: 10.3109/02699051003610508.

    PubMed 20235761

  • Xanthopoulos MS, Benton T, Lewis J, Case JA, Master CL. Mental Health in the Young Athlete. Curr Psychiatry Rep. 2020 Sep 21;22(11):63. doi: 10.1007/s11920-020-01185-w.

    PubMed 32954448

  • Mauck B, Kelly D, Sheffer B, Rambo A, Calandruccio JH. Gymnast's Wrist (Distal Radial Physeal Stress Syndrome). Orthop Clin North Am. 2020 Oct;51(4):493-497. doi: 10.1016/j.ocl.2020.06.012. Epub 2020 Aug 13.

    PubMed 32950218

  • Putukian M. The psychological response to injury in student athletes: a narrative review with a focus on mental health. Br J Sports Med. 2016 Feb;50(3):145-8. doi: 10.1136/bjsports-2015-095586. Epub 2015 Dec 30.

    PubMed 26719498

  • Pluhar E, McCracken C, Griffith KL, Christino MA, Sugimoto D, Meehan WP 3rd. Team Sport Athletes May Be Less Likely To Suffer Anxiety or Depression than Individual Sport Athletes. J Sports Sci Med. 2019 Aug 1;18(3):490-496. eCollection 2019 Sep.

    PubMed 31427871

  • McGuine TA, Winterstein A, Carr K, Hetzel S, Scott J. Changes in self-reported knee function and health-related quality of life after knee injury in female athletes. Clin J Sport Med. 2012 Jul;22(4):334-40. doi: 10.1097/JSM.0b013e318257a40b.

    PubMed 22627649

  • Valovich McLeod TC, Bay RC, Parsons JT, Sauers EL, Snyder AR. Recent injury and health-related quality of life in adolescent athletes. J Athl Train. 2009 Nov-Dec;44(6):603-10. doi: 10.4085/1062-6050-44.6.603.

    PubMed 19911086

  • Filbay S, Pandya T, Thomas B, McKay C, Adams J, Arden N. Quality of Life and Life Satisfaction in Former Athletes: A Systematic Review and Meta-Analysis. Sports Med. 2019 Nov;49(11):1723-1738. doi: 10.1007/s40279-019-01163-0.

    PubMed 31429036

  • Jayanthi NA, Post EG, Laury TC, Fabricant PD. Health Consequences of Youth Sport Specialization. J Athl Train. 2019 Oct;54(10):1040-1049. doi: 10.4085/1062-6050-380-18.

    PubMed 31633420

  • Pasulka J, Jayanthi N, McCann A, Dugas LR, LaBella C. Specialization patterns across various youth sports and relationship to injury risk. Phys Sportsmed. 2017 Sep;45(3):344-352. doi: 10.1080/00913847.2017.1313077. Epub 2017 Apr 10.

    PubMed 28351225

  • Li H, Moreland JJ, Peek-Asa C, Yang J. Preseason Anxiety and Depressive Symptoms and Prospective Injury Risk in Collegiate Athletes. Am J Sports Med. 2017 Jul;45(9):2148-2155. doi: 10.1177/0363546517702847. Epub 2017 Apr 25.

    PubMed 28441037

  • Chang C, Putukian M, Aerni G, Diamond A, Hong G, Ingram Y, Reardon CL, Wolanin A. Mental health issues and psychological factors in athletes: detection, management, effect on performance and prevention: American Medical Society for Sports Medicine Position Statement-Executive Summary. Br J Sports Med. 2020 Feb;54(4):216-220. doi: 10.1136/bjsports-2019-101583. Epub 2019 Dec 6.

    PubMed 31810972

Questions about this trial

What is this clinical trial studying?

An observational study of Musculoskeletal Injury and Quality of Life, run by University of Colorado, Denver at 1 site in United States.

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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Apr 2024. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Casey Little, BS (7207770109, casey.little@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-Reported Outcomes Measurement Information System (PROMIS) (time frame: 1 day Initial Visit). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05110729, which also lists 15 linked publications.

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 2 Apr 2024.

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