NCT05110729

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,218

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress90%
Nov 2021Nov 2026

First Submitted

Initial submission to the registry

October 22, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 12, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

October 22, 2021

Last Update Submit

April 1, 2024

Conditions

Keywords

GymnasticsQuality of Life and Life Satisfaction

Outcome Measures

Primary Outcomes (10)

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

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

    1 day Initial Visit

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

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

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

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

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

    1 day (At clearance visit to return to sport)

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

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

    6-months post initial visit

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

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

    12-months post initial visit

  • Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    Assessed at 1 day initial visit

  • Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

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

  • Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    1 day (At clearance visit to return to sport)

  • Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    6-months post initial visit

  • Tampa Scale for Kinesiophobia-11 (TSK-11)

    Questionnaire designed to assess patient fear of movement.

    12-months post initial visit

Secondary Outcomes (10)

  • Injury location and type questionnaire

    1 day Initial visit

  • Level of Specialization

    1 day (At clearance visit to return to sport)

  • Level of Specialization

    6-months post initial visit

  • Level of Specialization

    12-months post initial visit

  • Injury History

    Assessed at the patient's 1 day initial visit.

  • +5 more secondary outcomes

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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(

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Denver, Colorado, 80045, United States

RECRUITING

Related Publications (15)

  • 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.

    PMID: 30407945BACKGROUND
  • 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.

    PMID: 29740783BACKGROUND
  • 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.

    PMID: 28081205BACKGROUND
  • 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.

    PMID: 20235761BACKGROUND
  • 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.

    PMID: 32954448BACKGROUND
  • 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.

    PMID: 32950218BACKGROUND
  • 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.

    PMID: 26719498BACKGROUND
  • 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.

    PMID: 31427871BACKGROUND
  • 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.

    PMID: 22627649BACKGROUND
  • 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.

    PMID: 19911086BACKGROUND
  • 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.

    PMID: 31429036BACKGROUND
  • 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.

    PMID: 31633420BACKGROUND
  • 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.

    PMID: 28351225BACKGROUND
  • 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.

    PMID: 28441037BACKGROUND
  • 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.

    PMID: 31810972BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Emily Sweeney, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 8, 2021

Study Start

November 12, 2021

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations