Comparison of the Efficiency of Game-Based Exercise Program and Trunk Stabilization Exercise Training in Adolescent Playing Archery

June 5, 2023 updated by: Nilay Arman, Istanbul University - Cerrahpasa (IUC)

Game-Based Exercise Program and Trunk Stabilization Exercise Training in Adolescent Playing Archery

The aim of our study is to investigate the effects of a game-based exercise (Exergame) program and trunk stabilization exercise training on shooting performance, reaction time, trunk muscle endurance and balance in adolescents playing archery. While the importance of the effect of trunk stabilization on shooting performance is mentioned in individuals practicing archery, it is emphasized that trunk stabilization training increases sportive performance and protects against injuries in individuals interested in sports for the upper extremity. However, no study is found that directly compared game-based exercise programs and trunk stabilization exercise training in adolescents who play archery. Therefore, two different training programs will be given to the adolescents playing archery at the Archers Foundation Sports Club in Istanbul, and Shooting performance, reaction time, trunk muscle endurance, and balance levels will be evaluated before and after the training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • İstanbul University-Cerrahpaşa

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Archers who have been practicing archery for at least 1 year
  • Roller or Olympic archers

Exclusion Criteria:

  • Archers with a history of musculoskeletal injuries causing physical limitation in the last 6 months.
  • Archers who did not volunteer to participate in the study.
  • Archers with any visual and hearing disabilities.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trunk Stabilization Exercise Training Group
Other: Trunk Stabilization Exercise Training Group
The adolescents in this group who are involved in archery sports will be given 40 minutes of exercise training 2 days a week for 8 weeks. Exercise training will be applied as 5-10 minutes warm-up, 15-30 minutes trunk stabilization exercises, 5-10 minutes cooling down, and stretching exercises. The number of repetitions and difficulty levels of the exercises will gradually increase in the 3rd and 6th weeks.
Experimental: Game Based Exercise Program Group
Other: Game Based Exercise Program Group
At least 4 different games selected from Xbox 360 Kinect® games will be applied to adolescents practicing archery sports in this group for a total of 40 minutes with the physiotherapist. The games will be selected from games that include movement patterns similar to the exercises of the trunk stabilization exercise group. Game-based exercise training is planned to be performed twice a week for a total of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Core Endurance Tests
Time Frame: Change from baseline to 8 weeks
McGill's tests will be used to examine participants' core endurance. These tests consist of four positions: the trunk anterior flexor test, the right and left lateral plank, and the trunk posterior extensor test. Participants will perform one practice trial that will last a few seconds to confirm position and then one actual test trial will be recorded per position where the maximum time (seconds) participants could hold a static position was measured. The same investigator visually will determine the end of all tests.
Change from baseline to 8 weeks
Star Excursion Balance Test (SEBT) :
Time Frame: Change from baseline to 8 weeks
The test requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals. The participant performing the test must maintain their balance on one leg while using the other leg to reach as far as possible in 8 different directions. The participant (standing on his/her left leg for example) must reach in 8 different positions, once in each of the following directions: anterior, anteromedial, medial, posteromedial, posterior, posterolateral, lateral and anterolateral. The anterior, posteromedial and posterolateral directions appear to be important to identify individuals with chronic ankle instability and athletes at greater risk of lower extremity injury.
Change from baseline to 8 weeks
Reaction Time Evaluation:
Time Frame: Change from baseline to 8 weeks

It plans to use the free platform game (Reaction Time) available in the Android app. Test The test is performed using a tablet in a quiet and lighted room, the tablet will be placed on the desktop with a stabilizing stand.Athletes participating in the study will be asked to sit in a chair so that they are comfortable on the table.Test protocols after a verbal explanation, the athletes will be given one trial before the reaction time measurement. Stimuli given 5 times at fixed and random intervals, the average of the 5 trials results in the reaction time in milliseconds.

The participant is asked to touch the middle of the tablet screen with his finger when the blue color appears.When the green color appears, the screen continues to be touched, and when the green color appears, the screen is quickly stopped being touched. All athletes have a dominant and The non-dominant side uses the hands, index fingers.
Change from baseline to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Shooting Performance Evaluation:
Time Frame: Change from baseline to 8 weeks
Outdoor Shooting Performance: A total of 72 arrows, 2 x 36 arrows, will be shot at the distances specified by the International Archery Federation. The series were shot as 6 arrows each. A total of 360 points will be calculated. The higher the score, the better the performance of the athlete. Each athlete used his/her own bow and arrow, and the athlete must complete the shots within certain time limits.
Change from baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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