NCT07733648

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    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

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

  • Training Session Duration

    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

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

Study Arms (1)

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.

Other: FIFA 11

Interventions

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.

FIFA 11+ Exercise Program

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Turkey, +90, Turkey (Türkiye)

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations