Sport InjuriesNCT07733648
FIFA 11+ in Young Female Volleyball Players
A study testing FIFA 11 in people with Sport Injuries, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of an 8-week FIFA 11+ exercise program on wellness, rating of perceived exertion (RPE), dynamic balance, and single-leg functional performance in young female volleyball players, as well as to examine the relationships among these variables. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sport Injuries
- What is being tested?
- FIFA 11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female volleyball players aged 14-18 years
- Regular participation in volleyball training for at least 1 year
- Participation in training sessions at least 2 days per week
- No history of a serious lower-extremity injury within the previous 6 months
- Willingness to participate in the study and provision of written informed consent; for participants under 18 years of age, written parental or legal guardian consent will also be obtained
Who cannot join
- History of an injury requiring surgery within the previous 6 months
- Presence of acute pain or injury that prevents safe completion of the physical performance tests
- Presence of a neurological disorder or systemic disease that may affect balance or physical performance
- Inability to participate regularly in the FIFA 11+ exercise program
- Development of an injury during the study period that prevents participation in the exercise program for more than 2 consecutive weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of the FIFA 11+ Exercise Program on Injury Incidence, Fear of Reinjury, and Physical Performance in Young Female Volleyball Players
This study aims to investigate the effects of an 8-week FIFA 11+ exercise program on wellness, rating of perceived exertion (RPE), dynamic balance, and single-leg functional performance in young female volleyball players, as well as to examine the relationships among these variables. The study will also evaluate the program's effects on injury incidence and fear of reinjury.
The study is original in applying the FIFA 11+, a well-established injury prevention program, to volleyball and evaluating its effects together with training-load parameters through a multidimensional approach. It is expected to contribute to the literature by proposing a comprehensive model for monitoring athletic performance and injury risk in young female volleyball players.
- Conditions
- Sport Injuries
- Being tested
- FIFA 11
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIFA 11Other
Participants will undergo an 8-week non-intervention control period followed by a 2-week washout period and an 8-week FIFA 11+ exercise program in addition to regular volleyball training. The program consists of structured running, strength, balance, plyometric, and agility exercises. Wellness, rating of perceived exertion, dynamic balance, single-leg functional performance, injury incidence, and fear of reinjury will be assessed before and after the relevant study periods.
| Study group | Role | What they receive |
|---|---|---|
| FIFA 11+ Exercise Program | Experimental | Participants will undergo an 8-week non-intervention control period followed by a 2-week washout period and an 8-week FIFA 11+ exercise program in addition to regular volleyball training. The program consists of structured running, strength, balance, plyometric, and agility exercises. Wellness, rating of perceived exertion, dynamic balance, single-leg functional performance, injury incidence, and fear of reinjury will be assessed before and after the relevant study periods. Receives: Other: FIFA 11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury Incidence
All sports-related injuries occurring during the 8-week pre-intervention control period and the 8-week FIFA 11+ exercise intervention period will be prospectively recorded. Injury incidence will be calculated as the number of new injuries occurring during each study period. The anatomical location, type, severity, mechanism, and time-loss associated with each injury will also be documented.
Measured: During the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period
Re-Injury Anxiety Inventory Scores
Re-injury anxiety will be assessed using the Re-Injury Anxiety Inventory (RIAI). The inventory consists of two subscales: anxiety related to the rehabilitation process (RIAI-R) and anxiety related to returning to sport or competition (RIAI-RE). Each item is scored on a 4-point scale ranging from 0 ("Not at all") to 3 ("Very much").
The RIAI-R subscale includes 13 items, with total scores ranging from 0 to 39. The RIAI-RE subscale includes 15 items, with total scores ranging from 0 to 45. Higher scores indicate greater anxiety about sustaining another injury during rehabilitation or returning to sport. Subscale scores will be calculated separately according to the established scoring procedure, including reverse scoring of the relevant items.
Measured: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention
Daily Wellness Score
Athletes' daily wellness status will be assessed using a wellness questionnaire based on the Hooper Index. The questionnaire evaluates five parameters: sleep quality, fatigue, muscle soreness, stress, and mood. Each parameter will be self-rated on a scale from 1 to 10. Individual parameter scores and the total wellness score will be recorded to monitor athletes' daily physical and psychological status. Higher scores will be interpreted according to the direction of the scoring system specified in the study protocol.
Measured: Daily throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period
Single-Leg Hop for Distance Test
Lower-extremity functional performance will be assessed using the Single-Leg Hop for Distance Test. The athlete will stand on the test limb and perform a maximal forward hop, aiming to cover the greatest possible distance while landing on the same limb and maintaining balance.
The distance from the starting line to the point of heel contact at landing will be measured in centimeters. Three valid trials will be performed for each limb, and the longest distance will be recorded. A trial will be considered invalid if the athlete loses balance, touches the ground with the opposite foot, or takes an additional step after landing. Higher values indicate better functional performance.
Measured: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention
Vertical Jump Height
Lower-extremity explosive power will be assessed using the Vertical Jump Test. First, the athlete's maximal standing reach height will be measured while standing upright and reaching overhead with the dominant hand. The athlete will then perform a maximal vertical jump from a standardized starting position with knee flexion and touch the highest possible point.
Vertical jump height will be calculated as the difference between the maximal jump reach height and the standing reach height. Three valid trials will be performed, with adequate rest between trials, and the highest jump height will be recorded in centimeters. Higher values indicate greater lower-extremity explosive power.
Measured: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention
Secondary outcomes (3)
Session Rating of Perceived Exertion and Internal Training Load
Perceived exertion will be assessed after each training session using the Borg Category-Ratio 10 (CR-10) Scale. Athletes will rate their overall perceived exertion on a scale from 0 to 10, where 0 indicates "no exertion" and 10 indicates "maximal exertion." The session rating of perceived exertion (session-RPE) method will be used to calculate internal training load by multiplying the athlete's RPE score by the duration of the training session in minutes. Higher values indicate greater internal training load.
Measured: After each training session throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period
Training Session Duration
Training session duration will be recorded as the total time, in minutes, during which athletes actively participate in the main training component. Warm-up and cool-down periods will not be included. In addition, the total duration of moderate- and high-intensity activities performed during each session will be recorded separately as "fitness/aerobic minutes" to provide a more detailed estimate of the athletes' aerobic training exposure and internal workload.
Measured: Recorded during each training session throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period
Y-Balance Test Composite and Directional Reach Scores
Dynamic balance will be assessed using the Y-Balance Test. While standing on the test limb, the athlete will reach as far as possible with the opposite limb in the anterior, posteromedial, and posterolateral directions. The hands will remain on the hips, and the stance foot must remain stationary throughout the test.
Three valid trials will be performed in each direction, and the maximum reach distance will be recorded in centimeters. Reach distances will be normalized to limb length when appropriate. A trial will be considered invalid if the athlete loses balance, moves the stance foot, places weight through the reaching foot, or fails to return to the starting position under control.
Directional reach scores and the composite score will be calculated separately. Higher scores indicate better dynamic balance performance.
Measured: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport InjuriesStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733648
- Sponsor's protocol ID
- 2026-07/288
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the FIFA 11+ Exercise Program on Injury Incidence, Fear of Reinjury, and Physical Performance in Young Female Volleyball Players
- ClinicalTrials.gov ID
- NCT07733648
- Acronym / sponsor ID
- 2026-07/288
- Conditions
- Sport Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
This study aims to investigate the effects of an 8-week FIFA 11+ exercise program on wellness, rating of perceived exertion (RPE), dynamic balance, and single-leg functional performance in young female volleyball players, as well as to examine the relationships among these variables. The study will also evaluate the program's effects on injury incidence and fear of reinjury.
The study is original in applying the FIFA 11+, a well-established injury prevention program, to volleyball and evaluating its effects together with training-load parameters through a multidimensional approach. It is expected to contribute to the literature by proposing a comprehensive model for monitoring athletic performance and injury risk in young female volleyball players.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIFA 11+ Exercise Program | Experimental | Other: FIFA 11Participants will undergo an 8-week non-intervention control period followed by a 2-week washout period and an 8-week FIFA 11+ exercise program in addition to regular volleyball training. The program consists of structured running, strength, balance, plyometric, and agility exercises. Wellness, rating of perceived exertion, dynamic balance, single-leg functional performance, injury incidence, and fear of reinjury will be assessed before and after the relevant study periods. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female volleyball players aged 14-18 years
- Regular participation in volleyball training for at least 1 year
- Participation in training sessions at least 2 days per week
- No history of a serious lower-extremity injury within the previous 6 months
- Willingness to participate in the study and provision of written informed consent; for participants under 18 years of age, written parental or legal guardian consent will also be obtained
Key exclusion criteria (5 listed)
- History of an injury requiring surgery within the previous 6 months
- Presence of acute pain or injury that prevents safe completion of the physical performance tests
- Presence of a neurological disorder or systemic disease that may affect balance or physical performance
- Inability to participate regularly in the FIFA 11+ exercise program
- Development of an injury during the study period that prevents participation in the exercise program for more than 2 consecutive weeks
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 |
|---|---|---|
| FIFA 11Participants will undergo an 8-week non-intervention control period followed by a 2-week washout period and an 8-week FIFA 11+ exercise program in addition to regular volleyball training. The program consists of structured running, strength, balance, plyometric, and agility exercises. Wellness, rating of perceived exertion, dynamic balance, single-leg functional performance, injury incidence, and fear of reinjury will be assessed before and after the relevant study periods. | Other | FIFA 11+ Exercise Program |
Primary outcome
Injury Incidence
Time frame: During the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period
All sports-related injuries occurring during the 8-week pre-intervention control period and the 8-week FIFA 11+ exercise intervention period will be prospectively recorded. Injury incidence will be calculated as the number of new injuries occurring during each study period. The anatomical location, type, severity, mechanism, and time-loss associated with each injury will also be documented.
Re-Injury Anxiety Inventory Scores
Time frame: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention
Re-injury anxiety will be assessed using the Re-Injury Anxiety Inventory (RIAI). The inventory consists of two subscales: anxiety related to the rehabilitation process (RIAI-R) and anxiety related to returning to sport or competition (RIAI-RE). Each item is scored on a 4-point scale ranging from 0 ("Not at all") to 3 ("Very much"). The RIAI-R subscale includes 13 items, with total scores ranging from 0 to 39. The RIAI-RE subscale includes 15 items, with total scores ranging from 0 to 45. Higher scores indicate greater anxiety about sustaining another injury during rehabilitation or returning to sport. Subscale scores will be calculated separately according to the established scoring procedure, including reverse scoring of the relevant items.
Daily Wellness Score
Time frame: Daily throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period
Athletes' daily wellness status will be assessed using a wellness questionnaire based on the Hooper Index. The questionnaire evaluates five parameters: sleep quality, fatigue, muscle soreness, stress, and mood. Each parameter will be self-rated on a scale from 1 to 10. Individual parameter scores and the total wellness score will be recorded to monitor athletes' daily physical and psychological status. Higher scores will be interpreted according to the direction of the scoring system specified in the study protocol.
Single-Leg Hop for Distance Test
Time frame: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention
Lower-extremity functional performance will be assessed using the Single-Leg Hop for Distance Test. The athlete will stand on the test limb and perform a maximal forward hop, aiming to cover the greatest possible distance while landing on the same limb and maintaining balance. The distance from the starting line to the point of heel contact at landing will be measured in centimeters. Three valid trials will be performed for each limb, and the longest distance will be recorded. A trial will be considered invalid if the athlete loses balance, touches the ground with the opposite foot, or takes an additional step after landing. Higher values indicate better functional performance.
Vertical Jump Height
Time frame: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention
Lower-extremity explosive power will be assessed using the Vertical Jump Test. First, the athlete's maximal standing reach height will be measured while standing upright and reaching overhead with the dominant hand. The athlete will then perform a maximal vertical jump from a standardized starting position with knee flexion and touch the highest possible point. Vertical jump height will be calculated as the difference between the maximal jump reach height and the standing reach height. Three valid trials will be performed, with adequate rest between trials, and the highest jump height will be recorded in centimeters. Higher values indicate greater lower-extremity explosive power.
3 secondary outcomes
Session Rating of Perceived Exertion and Internal Training Load
Time frame: After each training session throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period
Training Session Duration
Time frame: Recorded during each training session throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period
Y-Balance Test Composite and Directional Reach Scores
Time frame: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIFA 11 in people with Sport Injuries, run by Acibadem University 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuray ALACA (05324251290, nuray.alaca@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury Incidence (time frame: During the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period). The study lists 5 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 29 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.