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

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

Study Locations

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.

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

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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