Exercise TrainingNCT02999139
Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention
An observational study of Exercise Training, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise Training
- How many people
- 633 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2016to 29 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Male and females age 6 and over.
Who may be able to join
- Males, Females, age 6 and over
Who cannot join
- younger than 6 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
The Micheli Center for Sports Injury Prevention
Waltham, Massachusetts, 02453
About this study
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.
- Conditions
- Exercise Training
- Keywords
- Injury, Prevention
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (5)
Training Habits
Surveys will answer if participants continue with their new training habits
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start13 Oct 2016
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daisuke Sugimoto, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999139
- Sponsor's protocol ID
- P00023758
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2016
- Last updated
- 5 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention
- ClinicalTrials.gov ID
- NCT02999139
- Acronym / sponsor ID
- P00023758
- Conditions
- Exercise Training
- Keywords
- Injury, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and females age 6 and over.
Key inclusion criteria (1 listed)
- Males, Females, age 6 and over
Key exclusion criteria (1 listed)
- younger than 6 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Injury
Time frame: 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.
For purposes of our study, an injury is one that: 1. occurred as a result of participation in sport AND 2. required medical attention by a team athletic trainer or a physician AND 3. resulted in restriction of the student-athlete's participation for one or more days beyond the day of injury OR 4. resulted in any fracture, concussion, or dental injury regardless of whether or not it resulted in restriction of the student-athlete's participation
5 secondary outcomes
Training Habits
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Training, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.