Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention

Participants who train at The Micheli Center for Sports Injury Prevention, will undergo testing of muscular strength, range of motion, flexibility, aerobic capacity and muscular endurance. They will complete training with a certified trainer and injury prevention specialist until their specific goals are meet. Upon completion of training, they will fill out an injury questionnaire every three months for five to ten years.

Study Overview

• Status: Completed
• Conditions: Exercise Training

• Study Type: Observational
• Enrollment (Actual): 633

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • The Micheli Center for Sports Injury Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and females age 6 and over.

Description

Inclusion Criteria:

• Males, Females, age 6 and over

Exclusion Criteria:

• younger than 6 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
ACL Return to Play; A specific training program, with emphasis on hamstring strengthening. There will also be a specificity on pivoting and jumping safely.
Gait Retraining; Will receive training that is specific to running. Drills will help enforce a more efficient running form, as well as strengthening important muscle groups such as the hip abductors and adductors.
Private Training; Participants will receive a broad training program, targeting all major muscle groups. The goal is to increase muscle strength, mobility and aerobic capacity to reduce the risk of injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injury	For purposes of our study, an injury is one that: occurred as a result of participation in sport AND; required medical attention by a team athletic trainer or a physician AND; resulted in restriction of the student-athlete's participation for one or more days beyond the day of injury OR; resulted in any fracture, concussion, or dental injury regardless of whether or not it resulted in restriction of the student-athlete's participation	After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training Habits	Surveys will answer if participants continue with their new training habits	After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.
Muscular Strength	This will be measured by hand held dynamometer pre and post training intervention. Will testing major muscles such as the quadriceps, hamstrings, biceps, triceps.	Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
Aerobic Capacity	This will be estimated by the step test, done pre and post training.	Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
Anaerobic Capacity	This will be measured by a series of tests such as the vertical jump test and shuttle run. These measures will be tested pre and post training.	Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
Range of Motion	This will be measured by goniometer at different joints such as the knee and ankle pre and post training.	Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2016
• Primary Completion (Actual): December 29, 2021
• Study Completion (Actual): December 29, 2021

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Prevention; Injury
• Other Study ID Numbers: P00023758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No