- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521215
Evaluation of Injury Risk Factors and Effects of Individualized Exercise Program in Basketball and Volleyball Athletes (IRISPORT)
Evaluation of Injury Risk Factors With Clinical/Functional Tests and Effects of Individualized Exercise Program in University Basketball and Volleyball Athletes: A Non-Randomized Parallel-Group Study
This study aims to identify injury risk factors using a clinical/functional test battery in university basketball and volleyball athletes, to develop individualized exercise prescriptions for athletes scoring below established cut-off values on each test, and to evaluate the effects of an 8-week intervention program on test parameters.
As a secondary aim, all participants will be monitored prospectively over a 6-month season to assess the incidence of injuries and health problems, and to evaluate the contribution of the individualized program to injury-related health outcomes.
The study consists of four phases: (1) baseline cross-sectional assessment (T0), (2) 8-week individualized exercise intervention for athletes below cut-off thresholds, (3) post-intervention reassessment (T1), and (4) 6-month prospective injury surveillance (T2).
Study Overview
Status
Intervention / Treatment
Detailed Description
BACKGROUND:
Musculoskeletal injuries in athletes represent a significant sports medicine and public health problem due to restricted training/competition participation, prolonged rehabilitation, and increased re-injury risk. Epidemiological data indicate that basketball and volleyball athletes carry elevated risk for lower extremity sprains/strains, knee ligament injuries, and overhead-related shoulder pathologies. University athletes are particularly vulnerable given the concurrent demands of intense academic schedules and high training loads.
Clinical/functional tests can systematically identify modifiable risk factors including neuromuscular control, balance, flexibility, and functional strength. The Y-Balance Test (YBT-LQ), Hop-for-Distance Test (Limb Symmetry Index), Active Straight Leg Raise (ASLR), Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), and Glenohumeral Internal Rotation Deficit (GIRD) assessment are employed in this study, each with established reliability and predictive validity.
STUDY DESIGN:
This is a non-randomized, parallel-group interventional study. Athletes scoring below literature-defined cut-off values on any test receive test-specific individualized exercise prescriptions (Intervention Group), while athletes meeting all cut-off thresholds receive no intervention and serve as the observation group. Both groups undergo identical assessment at T0 and T1, and are monitored for injuries through T2.
INTERVENTION:
The 8-week individualized exercise program is prescribed based on each athlete's specific deficits:
- YBT-LQ below cut-off (composite score less than 94% or asymmetry greater than 4 cm): Dynamic balance and proprioception exercises
- Hop Test LSI below 90%: Plyometric control and symmetry exercises
- ASLR below 70 degrees: Hamstring/posterior chain flexibility exercises
- CKCUEST below cut-off (males less than 21, females less than 23 touches): Scapular stability and upper extremity endurance exercises
- GIRD above cut-off (internal rotation deficit greater than 20 degrees or total rotation difference greater than 5 degrees): Posterior shoulder capsule and rotator cuff exercises
Frequency: 3 days/week, 20-30 minutes per session. First 2 weeks supervised, subsequent weeks partially independent. Weekly compliance logged.
INJURY SURVEILLANCE (T2):
All participants are monitored for 6 months using IOC 2020 Consensus Statement methodology. Events are classified by type (injury/illness), onset (acute/overuse), anatomical region, severity (time-loss days), and recurrence status. Participant reports are cross-checked with team staff records where available.
STATISTICAL ANALYSIS:
Descriptive statistics (mean +/- SD, median, frequencies). T0-T1 comparisons: paired t-test or Wilcoxon signed-rank test (only athletes below cut-off for each respective test). Between-branch comparisons: independent t-test / Mann-Whitney U, chi-square / Fisher exact test. Effect sizes (Cohen's d). Injury incidence comparison between intervention and observation groups at T2. Significance level: p less than 0.05.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ali Omer Acar
- Phone Number: +905378262790
- Email: aliomer.acar@acibadem.edu.tr
Study Contact Backup
- Name: Selcuk Marangoz
- Phone Number: +905355775928
- Email: selcuk.marangoz@acibadem.edu.tr
Study Locations
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Istanbul, Turkey (Türkiye)
- Acibadem Mehmet Ali Aydinlar University, Department of Physiotherapy and Rehabilitation
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Contact:
- Ali Omer Acar
- Phone Number: +905378262790
- Email: aliomer.acar@acibadem.edu.tr
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Principal Investigator:
- Ali Omer Acar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Active member of Acibadem University basketball or volleyball team
- Regular training within the past 6 months
- Age 18 years or older
- Willing to participate and provide written informed consent
- Physical and cognitive capacity to complete test protocols
Exclusion Criteria:
- Surgical intervention within the past 6 months
- Acute musculoskeletal injury within the past 2 weeks (acute sprain/strain/contusion etc.) that would preclude testing
- History of vestibular disorder, neurological disease, or systemic condition that may affect balance testing
- Uncontrolled cardiovascular disease/hypertension or other medical condition contraindicating exercise
- Pregnancy or within the first 6 months postpartum (female athletes)
- Refusal to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individualized Exercise Intervention
Athletes scoring below established literature cut-off values on one or more clinical/functional tests at baseline (T0).
Each athlete receives a test-specific individualized exercise prescription targeting their identified deficits.
The program is administered 3 days/week for 8 weeks (20-30 min/session), with supervised sessions in weeks 1-2 and partially independent sessions in weeks 3-8.
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An 8-week individualized exercise program prescribed based on each athlete's baseline test deficits. Components include:
Dosage: 3 sessions/week, 20-30 minutes/session. Progressive overload applied. Weekly compliance monitored. |
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No Intervention: Observation (No Intervention)
Athletes meeting all literature-defined cut-off thresholds on every clinical/functional test at baseline (T0).
These athletes continue their routine training without additional exercise intervention.
They undergo the same T0 and T1 assessments and 6-month injury surveillance as the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Y-Balance Test Lower Quarter (YBT-LQ) Composite Score
Time Frame: Baseline (T0) and 8 weeks (T1)
|
Composite score calculated as [(Anterior + Posteromedial + Posterolateral) / (3 x Leg Length)] x 100.
Assessed bilaterally.
Cut-off: composite score less than 94% or right-left asymmetry greater than 4 cm.
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Baseline (T0) and 8 weeks (T1)
|
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Change in Hop-for-Distance Test Limb Symmetry Index (LSI)
Time Frame: Baseline (T0) and 8 weeks (T1)
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LSI calculated as (Weaker Side / Stronger Side) x 100.
Three trials per limb, best distance recorded.
Cut-off: LSI less than 90%.
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Baseline (T0) and 8 weeks (T1)
|
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Change in Active Straight Leg Raise (ASLR) Hip Flexion Angle
Time Frame: Baseline (T0) and 8 weeks (T1)
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Hip flexion range of motion measured by goniometry in supine position with knee extended.
Two measurements per limb, average recorded.
Cut-off: hip flexion less than 70 degrees.
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Baseline (T0) and 8 weeks (T1)
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Change in Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) Score
Time Frame: Baseline (T0) and 8 weeks (T1)
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Number of hand touches in 15 seconds from push-up position with hands 91 cm apart.
Three trials, best score recorded.
Cut-off: males less than 21 touches, females less than 23 touches.
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Baseline (T0) and 8 weeks (T1)
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Change in Glenohumeral Internal Rotation Deficit (GIRD)
Time Frame: Baseline (T0) and 8 weeks (T1)
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Internal and external rotation measured by goniometry in supine (shoulder 90 degrees abduction, elbow 90 degrees flexion), scapula stabilized.
GIRD = non-dominant IR minus dominant IR.
Cut-off: IR deficit greater than 20 degrees or total rotation difference greater than 5 degrees.
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Baseline (T0) and 8 weeks (T1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Musculoskeletal Injuries and Health Problems
Time Frame: 6 months (T0 through T2)
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Prospective injury surveillance using IOC 2020 Consensus Statement methodology.
Events classified by type (injury/illness), onset (acute/overuse), anatomical region, severity (time-loss: 0, 1-3, 4-7, 8-28, greater than 28 days), and recurrence.
Comparison between intervention and observation groups.
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6 months (T0 through T2)
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Pittsburgh Sleep Quality Index (PSQI) Global Score
Time Frame: Baseline (T0)
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Self-report measure of sleep quality over the past month.
19 items, 7 components, global score 0-21.
Higher scores indicate poorer sleep quality.
Global PSQI greater than 5 indicates clinically significant poor sleep quality.
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Baseline (T0)
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Borg Rating of Perceived Exertion (RPE)
Time Frame: Baseline (T0)
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Perceived exertion level assessed using the Borg RPE Scale (6-20).
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Baseline (T0)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Omer Acar, Acibadem Mehmet Ali Aydinlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACU-FTR-AOA4
- 2026-04/168 (Other Identifier: ATADEK Ethics Committee Approval Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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