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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05110729
Collaborator
(none)
1,218
1
59.6
20.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1218 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Quality of Life and Life Satisfaction in Pediatric and Adolescent Gymnasts Through Injury
    Actual Study Start Date :
    Nov 12, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2026
    Anticipated Study Completion Date :
    Nov 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Patient-Reported Outcomes Measurement Information System (PROMIS) [1 day Initial Visit]

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

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

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

    4. Patient-Reported Outcomes Measurement Information System (PROMIS) [6-months post initial visit]

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

    5. Patient-Reported Outcomes Measurement Information System (PROMIS) [12-months post initial visit]

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

    6. Tampa Scale for Kinesiophobia-11 (TSK-11) [Assessed at 1 day initial visit]

      Questionnaire designed to assess patient fear of movement.

    7. Tampa Scale for Kinesiophobia-11 (TSK-11) [At follow up visit, up to 3 months post initial visit]

      Questionnaire designed to assess patient fear of movement.

    8. Tampa Scale for Kinesiophobia-11 (TSK-11) [1 day (At clearance visit to return to sport)]

      Questionnaire designed to assess patient fear of movement.

    9. Tampa Scale for Kinesiophobia-11 (TSK-11) [6-months post initial visit]

      Questionnaire designed to assess patient fear of movement.

    10. Tampa Scale for Kinesiophobia-11 (TSK-11) [12-months post initial visit]

      Questionnaire designed to assess patient fear of movement.

    Secondary Outcome Measures

    1. Injury location and type questionnaire [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.

    2. Level of Specialization [1 day (At clearance visit to return to sport)]

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

    3. Level of Specialization [6-months post initial visit]

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

    4. Level of Specialization [12-months post initial visit]

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

    5. Injury History [Assessed at the patient's 1 day initial visit.]

      Patient-reported history of previous musculoskeletal injuries.

    6. Pittsburgh Sleep Quality Index (PSQI) [Assessed at initial 1 day visit]

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

    7. Pittsburgh Sleep Quality Index (PSQI) [At follow up visit, up to 3 months post initial visit]

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

    8. Pittsburgh Sleep Quality Index (PSQI) [1 day (At clearance visit to return to sport)]

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

    9. Pittsburgh Sleep Quality Index (PSQI) [6-months post initial visit]

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

    10. Pittsburgh Sleep Quality Index (PSQI) [12-months post initial visit]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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(

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Colorado Denver Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Emily Sweeney, MD, Children's Hospital Colorado

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT05110729
    Other Study ID Numbers:
    • 21-4271
    First Posted:
    Nov 8, 2021
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of Colorado, Denver
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2022