- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05110729
Quality of Life and Life Satisfaction in Pediatric and Adolescent Gymnasts Through Injury
April 1, 2024 updated by: University of Colorado, Denver
This study aims to assess the quality and life and life satisfaction of pediatric and adolescent gymnasts throughout their musculoskeletal injury recovery.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
1218
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Casey Little, BS
- Phone Number: 7207770109
- Email: casey.little@childrenscolorado.org
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80045
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Emily Sweeney, MD
- Email: Emily.Sweeney@childrenscolorado.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from Children's Hospital Colorado Sports medicine and Orthopedic outpatient clinics.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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(
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame: 1 day Initial Visit
|
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)
Time Frame: At follow up visit, up to 3 months post initial visit
|
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)
Time Frame: 1 day (At clearance visit to return to sport)
|
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)
Time Frame: 6-months post initial visit
|
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)
Time Frame: 12-months post initial visit
|
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)
Time Frame: Assessed at 1 day initial visit
|
Questionnaire designed to assess patient fear of movement.
|
Assessed at 1 day initial visit
|
|
Tampa Scale for Kinesiophobia-11 (TSK-11)
Time Frame: At follow up visit, up to 3 months post initial visit
|
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)
Time Frame: 1 day (At clearance visit to return to sport)
|
Questionnaire designed to assess patient fear of movement.
|
1 day (At clearance visit to return to sport)
|
|
Tampa Scale for Kinesiophobia-11 (TSK-11)
Time Frame: 6-months post initial visit
|
Questionnaire designed to assess patient fear of movement.
|
6-months post initial visit
|
|
Tampa Scale for Kinesiophobia-11 (TSK-11)
Time Frame: 12-months post initial visit
|
Questionnaire designed to assess patient fear of movement.
|
12-months post initial visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Injury location and type questionnaire
Time Frame: 1 day Initial visit
|
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.
|
1 day Initial visit
|
|
Level of Specialization
Time Frame: 1 day (At clearance visit to return to sport)
|
Questionnaire designed to identify an athlete's level of sport specialization.
|
1 day (At clearance visit to return to sport)
|
|
Level of Specialization
Time Frame: 6-months post initial visit
|
Questionnaire designed to identify an athlete's level of sport specialization.
|
6-months post initial visit
|
|
Level of Specialization
Time Frame: 12-months post initial visit
|
Questionnaire designed to identify an athlete's level of sport specialization.
|
12-months post initial visit
|
|
Injury History
Time Frame: Assessed at the patient's 1 day initial visit.
|
Patient-reported history of previous musculoskeletal injuries.
|
Assessed at the patient's 1 day initial visit.
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Assessed at initial 1 day visit
|
Questionnaire used to determine the participant's quality of sleep.
|
Assessed at initial 1 day visit
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At follow up visit, up to 3 months post initial visit
|
Questionnaire used to determine the participant's quality of sleep.
|
At follow up visit, up to 3 months post initial visit
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 1 day (At clearance visit to return to sport)
|
Questionnaire used to determine the participant's quality of sleep.
|
1 day (At clearance visit to return to sport)
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 6-months post initial visit
|
Questionnaire used to determine the participant's quality of sleep.
|
6-months post initial visit
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 12-months post initial visit
|
Questionnaire used to determine the participant's quality of sleep.
|
12-months post initial visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emily Sweeney, MD, Children's Hospital Colorado
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Curr Psychiatry Rep. 2020 Oct 2;22(12):64.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2021
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
October 22, 2021
First Submitted That Met QC Criteria
November 5, 2021
First Posted (Actual)
November 8, 2021
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-4271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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