Athlete; ItchNCT05623657
Comparison of the Efficiency of Game-Based Exercise Program and Trunk Stabilization Exercise Training in Adolescent Playing Archery
A study testing Trunk Stabilization Exercise Training Group and Game Based Exercise Program Group in people with Athlete; Itch, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Athlete; Itch
- What is being tested?
- Trunk Stabilization Exercise Training Group and Game Based Exercise Program Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2022to 2 Mar 2023
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Archers who have been practicing archery for at least 1 year
- Roller or Olympic archers
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Athlete; Itch
- Being tested
- Trunk Stabilization Exercise Training Group, Game Based Exercise Program Group
- Keywords
- Archery, trunk, balance, exergame, core stability
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk Stabilization Exercise Training GroupOther
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.
Game Based Exercise Program GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Trunk Stabilization Exercise Training Group | Experimental | Not described Receives: Other: Trunk Stabilization Exercise Training Group |
| Game Based Exercise Program Group | Experimental | Not described Receives: Other: Game Based Exercise Program Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Endurance Tests
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.
Measured: Change from baseline to 8 weeks
Star Excursion Balance Test (SEBT) :
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.
Measured: Change from baseline to 8 weeks
Reaction Time Evaluation:
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.
Measured: Change from baseline to 8 weeks
Secondary outcomes (1)
Shooting Performance Evaluation:
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.
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start30 May 2022
- Primary completion30 Dec 2022
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athlete; ItchStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Arman, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623657
- Sponsor's protocol ID
- 00001
- Status last verified
- Jun 2023
- First submitted
- 12 Nov 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game-Based Exercise Program and Trunk Stabilization Exercise Training in Adolescent Playing Archery
- ClinicalTrials.gov ID
- NCT05623657
- Acronym / sponsor ID
- 00001
- Conditions
- Athlete; Itch
- Keywords
- Archery, trunk, balance, exergame, core stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trunk Stabilization Exercise Training Group | Experimental | Other: Trunk Stabilization Exercise Training Group |
| Game Based Exercise Program Group | Experimental | Other: Game Based Exercise Program Group |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Archers who have been practicing archery for at least 1 year
- Roller or Olympic archers
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trunk Stabilization Exercise Training GroupThe 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. | Other | Trunk Stabilization Exercise Training Group |
| Game Based Exercise Program GroupAt 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. | Other | Game Based Exercise Program Group |
Primary outcome
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.
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.
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.
1 secondary outcome
Shooting Performance Evaluation:
Time frame: Change from baseline to 8 weeks
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 7 Jun 2023.
- Individual participant dataSharing planned: No
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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?
A study testing Trunk Stabilization Exercise Training Group and Game Based Exercise Program Group in people with Athlete; Itch, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 7 Jun 2023. 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 Turkey (Türkiye). 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?
Core Endurance Tests (time frame: Change from baseline to 8 weeks). The study lists 3 primary outcomes in all. 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 7 Jun 2023.