ClinicalTrials.gg
Not yet recruitingNCT07733648Updated Jul 29, 2026

FIFA 11+ in Young Female Volleyball Players

An interventional study of FIFA 11 in Sport Injuries, sponsored by Acibadem University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Acibadem University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
14 Years to 18 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Sport Injuries

Browse trials for

03

In context

Athletic Injuries

258 studies on the registry are indexed under Athletic Injuries; 45 are open to participants now.

This study's planned enrollment of 25 is below the median of 44 across 164 interventional studies indexed under Athletic Injuries.

Browse Athletic Injuries studies →

Lead sponsor

Acibadem University is the lead sponsor of 220 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 ; for participants under 18 years of age, written parental or legal guardian consent will also be obtained

Exclusion criteria

Exclusion Criteria

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    FIFA 11+ Exercise Program

    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.

    Other: FIFA 11

Interventions

  • OtherFIFA 11

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period

  2. 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.

    Time frame: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention

  3. 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.

    Time frame: Daily throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period

  4. 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.

    Time frame: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention

  5. 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.

    Time frame: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention

Secondary outcomes

  1. 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.

    Time frame: After each training session throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period

  2. 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.

    Time frame: Recorded during each training session throughout the 8-week pre-intervention control period and the 8-week FIFA 11+ intervention period

  3. 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.

    Time frame: At the end of the 8-week pre-intervention control period and immediately after the 8-week FIFA 11+ intervention

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Nov 2026, 2 months later.

Of 119 non-industry interventional studies with no phase under Athletic Injuries, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 14. This study's planned 2 months is below that.

Counting every sponsor, half of 121 studies reached it within 5 months; a quarter within 2 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2026
First posted
Jul 29, 2026
StartEst.
Sep 10, 2026
Primary completionEst.
Nov 10, 2026
CompletionEst.
Jan 15, 2027
Last update
Jul 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07733648
Responsible party
Nuray Alaca (Assoc. Prof, Acibadem University) — Principal investigator
First posted
Jul 29, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Nov 10, 2026 (estimated)
Completion
Jan 15, 2027 (estimated)
Last update
Jul 29, 2026

Study contacts

Nuray ALACA
Contact
nuray.alaca@acibadem.edu.tr
05324251290

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion