BFR Rope Training in Male Volleyball Players (8wBFR_rope)

December 26, 2025 updated by: Neslihan AKÇAY, Karabuk University

The Effects of Blood Flow Restriction Rope Training on Athletic Performance, Muscle Strength, and Hypertrophy in Male Volleyball Players

The study will be conducted during the preparatory period of the volleyball players and will span eight weeks. Throughout this period, athletes will continue their regular volleyball training four days per week, while the experimental group (n = 10) will perform rope training with blood flow restriction (BFR) twice per week, and the control group (n = 10) will perform the same rope training without BFR. Assessments will be carried out at the beginning of the 8-week period (pre-test) and at the end of the intervention (post-test). For both groups, all exercises will target the upper-extremity muscle groups. During the study, participants will be instructed to avoid consuming any medications, engaging in additional strenuous physical activities, and using any techniques or ergogenic aids that might influence the results. In both testing sessions, a standardized warm-up protocol will be implemented, consisting of a 5-minute treadmill run at 9 km/h on a Sprint Runner device (Hoggan Health Industries, Draper, UT), followed by 3 minutes of light full-body stretching. This warm-up procedure will be applied consistently across both groups to ensure standardization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to investigate the effects of blood flow restriction (BFR) rope training on athletic performance, muscle strength, and muscle hypertrophy in male volleyball players through an eight-week intervention. Conducted during the athletes' preparatory period, the study requires participants to perform rope-training sessions four days per week in addition to their regular volleyball training. On the first day, all athletes will undergo anthropometric measurements, and a familiarization session will be conducted to minimize potential learning effects. Participants will then be randomly assigned to either a BFR rope-training experimental group (BFR) or a control group (CON) performing standard rope training. Both groups will follow a progressive training protocol consisting of three sets and five exercises, while the BFR group will train under a cuff pressure set at 60% of limb occlusion pressure (LOP). Throughout the training sessions, heart rate, rating of perceived exertion (RPE), perceived discomfort (PD), OMNI-RES exercise difficulty, and PACES exercise enjoyment scores will be recorded. Pre- and post-intervention assessments will include ultrasound measurements of muscle thickness and cross-sectional area, one-repetition maximum (1RM) tests for biceps and triceps, upper-body strength tests (push-ups, sit-ups, and squats), shoulder strength using a Lafayette device, handgrip strength, aerobic endurance via the Yo-Yo IR1 test, anaerobic performance via the Wingate test, and volleyball serve speed measurements. All exercises will target upper-extremity muscle groups, and participants will be instructed to refrain from using any medications, ergogenic aids, or additional strenuous exercise that could influence outcomes. During both pre- and post-testing sessions, all athletes will complete a standardized warm-up protocol consisting of a 5-minute treadmill run at 9 km/h followed by 3 minutes of light full-body stretching. This comprehensive design aims to provide valuable insights into how BFR-based rope training influences performance adaptations in volleyball athletes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Neslihan Akçay, Doctorate

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Karabük, Turkey, Turkey (Türkiye), 78200
        • Karabuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being healthy
  • Male volleyball athletes
  • Willing to maintain the intervention for all sessions

Exclusion Criteria:

  • Being under 18 years old
  • Having a chronic disease
  • Contraindications for exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Blood Pressure
Determination of Blood Pressure
Other: Blood Pressure
A digital Omron device (model M2; Ankara, Turkey) will be used to measure participants' resting blood pressure. Prior to exercise, systolic, diastolic, and heart rate values will be recorded, and individuals outside the 140/90 mmHg range will be excluded. Participants will remain seated for 10 minutes, after which three measurements will be taken from the dominant arm with at least 1 minute between readings. Resting blood pressure will be calculated as the average of these three values, following American Heart Association guidelines (Pickering et al., 2005).
Experimental: Muscle Strength
Determination of Muscle Strength
Other: Muscle Strength
Dominant and non-dominant shoulder internal and external rotation strength will be assessed using a Lafayette digital handheld dynamometer. This portable device provides peak force, time to peak force, total test duration, and average force in kilograms, Newtons, and pounds. Participants will receive verbal instructions and complete a familiarization trial before testing. The "make test" technique will be used, in which the examiner stabilizes the device while the participant applies maximal isometric force. All measurements will be taken twice by the same trainer. Prior to testing, a 10-minute warm-up including upper-extremity and shoulder rotation movements will be performed. Participants will then lie supine on a flat surface, and dominant and non-dominant internal and external rotation strength will be measured and recorded (Kesilmiş & Manolya, 2020).
Other: Serve Speed
Determination of Serve Speed
Other: Serve Speed
The serve speed test will be conducted in the Hasan Doğan Sports Sciences Gymnasium at Karabük University using official balls (FIVB Beach Championship VLS300 MIKASA). Athletes will begin with a 15-minute warm-up consisting of joint mobility exercises (e.g., knee flexion/extension, shoulder rotation, ankle dorsiflexion), followed by technical movements such as ball-free jumping and running to enhance coordination. Each player will then perform ten practice serves. A total of 196 power-kick serves (28 per participant) will be recorded without opposition. After each isometric exercise, participants will execute four maximal-intensity serves, and ball speed will be determined from these attempts. Athletes will be encouraged to strike the ball with maximum force. A radar device will be positioned 8 m behind the service line and 3 m above the ground to capture serve velocity at a height consistent with ball-hand contact (Buscà et al., 2012). Serve speed will be measured using a standard ra
Other: Blood Flow Restriction (BFR)
Blood Flow Restriction Protocol
Other: Blood Flow Restriction
The arterial occlusion pressures (AOP) of the athletes randomized to the experimental group will be automatically determined using a digital LED-display BFR device (Fit Cuffs BFR, Denmark). Optimal cuff width, occlusion pressure, and exercise procedures have been previously described in the literature (Loenneke et al., 2015; Scott et al., 2015). A 4-inch-wide tourniquet will be applied to the upper arm of the participant's dominant limb. During the exercise, the AOP will be maintained at 60% using the Fit Cuffs BFR Unit (Denmark), and consistent pressure will be applied to the limb throughout the full range of motion. All participants will use the same cuff model, and 60% AOP will be administered with an FDA/CE-approved automatic Smart Cuffs Pro device (Elite, USA), applied to the proximal region of the arm.
Other: Rating of Perceived Exertion (RPE)
Determination of Perceived Exertion
Other: Rating of Perceived Exertion
After each training session, RPE will be collected using the 6-20 Borg Scale at the end of the session, where 6 indicates "no exertion" and 20 indicates "maximal exertion" (Foster et al., 2021).
Other: Battle Rope Training
Battle Rope Training Protocol
Other: Battle Rope Training
Based on prior literature recommending battle ropes measuring 12-15 m in length, 3-5 cm in diameter, and 9-16 kg in weight (Pustina et al., 2017; Tessitore et al., 2006; Ziy et al., 2009), this study will use a 12-m, 3.8-cm diameter, 12-kg rope. Participants will perform wave-style rope exercises in a standing position with feet shoulder-width apart and the trunk flexed forward at approximately 30-45°. The rope will be anchored at its midpoint to a stable object, and participants will grip the ends (5 m ± 5 cm each) and execute bilateral oscillations. The protocol will include three sets of five exercises, with progressive durations across the 8-week period: 15 seconds in Weeks 1-2, 20 seconds in Weeks 3-5, and 25 seconds in Weeks 6-8. Rest intervals between sets will remain consistent at 45 seconds throughout the training program.
Other: Arm Circumference
Arm Circumference Measurement
Other: Arm Circumference
Before the training session and without performing any physical activity, arm circumference will be measured using a 300-cm non-elastic measuring tape. Measurements will be taken at a 90° elbow angle from the midpoint of the upper arm, over the biceps muscle (Otman, 2003).
Other: Skeletal Muscle Endurance
Skeletal Muscle Endurance Tests (Sit-Up, Push-Up, and Pull-Up)
Other: Skeletal Muscle Endurance
Upper-body and trunk muscular endurance will be assessed using standardized ACSM protocols. Upper-body endurance will be measured with the ACSM push-up test: men will perform standard push-ups, while women will complete kneeling push-ups. The test will stop at volitional fatigue or after two consecutive form errors (chin to mat and full elbow extension). Trunk endurance will be evaluated using the cadence-based YMCA bent-knee sit-up test, performed at one repetition every 2 seconds until volitional fatigue. A valid sit-up requires elbows touching the knees and returning to the starting position in cadence. Upper-body pulling endurance will be tested with a pronated-grip pull-up test. Repetitions must include the chin rising above the bar and full controlled elbow extension. The test ends at volitional fatigue or after repeated form errors. All endurance tests (push-up, sit-up, pull-up) will be performed to volitional fatigue with 2-3 minutes of rest between tests, and the same test
Other: Anaerobic Power
Anaerobic Power Assessment
Other: Anaerobic Power
The Wingate Anaerobic Power Test (WAnT) is a widely used 30-second cycling test designed to measure short-term, high-intensity power output and anaerobic energy system capacity (Reiser et al., 2002). Conducted on a Monark 894E ergometer, the test uses a resistance load adjusted to each participant's body mass (Jaafar et al., 2014). Before testing, participants will complete a 4-5 minute warm-up at 60-70 W and 60-70 rpm, including 2-3 short sprints, followed by 3-5 minutes of passive rest. Saddle and handlebar settings will be adjusted so the knee reaches full extension at the lowest pedal position, and feet will be secured with clips. Participants will accelerate to maximal speed without resistance; once they reach 150 rpm, the programmed resistance load will automatically engage. They will then pedal maximally for 30 seconds against this resistance while receiving verbal encouragement (Ozkan, 2007).
Other: Bench Press 1RM Test
Bench Press 1RM Test Measurement
Other: Bench Press 1RM Test
Participants will begin with a 5-minute treadmill warm-up at 9 km/h followed by three minutes of light stretching (do Carmo et al., 2021). A specific warm-up will then be performed: 5 reps at 50% of estimated 1RM, followed by 1-2 sets of 2-3 reps at 60-80%. After warm-up, participants will perform single-rep attempts with gradually increasing loads to determine their 1RM, resting 3-5 minutes between trials. Up to five attempts will be used to identify the true 1RM (Schoenfeld et al., 2016).
Other: Triceps Push-Down 1RM Test
Triceps Push-Down 1RM Test Measurement
Other: Triceps Push-Down 1RM Test
Participants will stand in front of the triceps push-down machine, gripping the bar with a shoulder-width pronated grip. Throughout the exercise, the arms will be kept close to the torso, with the trunk slightly leaned forward, ensuring that the hands do not touch the body during full elbow extension. Participants will push the bar downward until reaching full elbow extension, then return to the starting position in a controlled manner; this will count as one repetition. The maximum load that each participant can successfully lift for one full repetition will be recorded as their 1RM (Hussain et al., 2020).
Other: Hand Grip Strength Test
Hand Grip Strength Test Measurement
Other: Hand Grip Strength Test
A calibrated hand grip dynamometer (Takei 5101, Tokyo, Japan) will be used to evaluate maximal hand grip strength. Participants will be instructed to grasp the dynamometer with their hand while exerting maximal isometric force, maintaining extended elbows and a neutral wrist position at the lateral side of the body. The testing protocol will include two trials with a 60-second rest interval between them. The highest value obtained will be recorded as the maximal force output. Throughout the test, participants will be strongly encouraged to exert maximal effort (Lopes-Silva et al., 2022).
Other: Yo-Yo IR1 Test
Yo-Yo IR1 Test Measurement
Other: Yo-Yo IR1 Test
The Yo-Yo Intermittent Recovery Level 1 (Yo-Yo IR1) test will be used to assess intermittent endurance capacity (Krustrup et al., 2003). Participants will complete 20 m shuttle runs at progressively increasing speeds, with 10 seconds of active recovery (light jogging over 2 m × 5 m) between runs. The test will stop when the participant can no longer maintain the required pace or fails to reach the line on time for two consecutive shuttles. Performance will be scored by the total distance (number of completed shuttles). A familiarization trial will be conducted before testing. The Yo-Yo IR1 demonstrates high reliability (ICC = 0.94; CV = 3.6%) (Krustrup et al., 2003).
Other: Ultrasound (US)
Ultrasound (US) Measurements
Other: Ultrasound (US)
Muscle thickness and cross-sectional area (CSA) will be measured 48-72 hours after the final training session, with no prior physical activity. A blinded physician will conduct all assessments using standardized anatomical points for the biceps brachii, triceps brachii, brachialis, anterior deltoid, upper trapezius, and rectus abdominis. Measurements will be taken in the axial plane with a light, 90° probe contact. A Toshiba Aplio 500 ultrasound device (10 MHz linear probe) will be used. CSA will be calculated by tracing the inner muscle border, and muscle thickness will be measured between superficial and deep aponeuroses. Two radiology specialists will evaluate the results jointly (Kubo et al., 2011).
Other: Perceived Discomfort Level
Determination of Perceived Discomfort Level
Other: Perceived Discomfort Level
Perceived Discomfort Level (PDL) will be assessed using a scale ranging from 0 ("no discomfort") to 10 ("maximum discomfort") (Borg, 1998). The PDL will be evaluated twice: once for overall body discomfort and once specifically for arm discomfort.
Other: Exercise Enjoyment
Exercise Enjoyment Assessment
Other: Exercise Enjoyment
Exercise enjoyment will be measured using the shortened 8-item version of the Physical Activity Enjoyment Scale (PACES), originally developed by Kendzierski and DeCarlo (1991) and later adapted by Raedeke (2007). This single-factor scale evaluates the level of enjoyment experienced during exercise. Each item is rated on a 7-point Likert scale ranging from 1 ("do not enjoy at all") to 7 ("enjoy very much"), with 4 representing a neutral midpoint. Higher scores indicate greater enjoyment derived from the physical activity (Soylu et al., 2023).
Other: Perceived Exertion Level (OMNI-RES)
Perceived Exertion Level Assessment
Other: Perceived Exertion Level (OMNI-RES)
The OMNI-RES resistance exercise scale will be used to assess participants' perceived exertion levels. A rating will be recorded at the end of each set, and the average of all set scores will be calculated and documented at the end of the exercise session. The scale will remain within the participant's visual field throughout the session, and they will be instructed to focus on their sense of effort immediately before each rating. Using standardized definitions and instructions, participants will rate their exertion on a scale ranging from 0 ("extremely easy") to 10 ("extremely hard") (Robertson et al., 2003).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle Thickness (Ultrasound) - Biceps, Triceps, Brachialis, Antrerior Deltoid, Upper Trapezius, Rectus Abdominis
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in muscle thickness (mm) from baseline to 8-week follow-up as measured by diagnostic ultrasound.
From baseline assessment to 8-week follow-up assessment
Muscle Cross-Sectional Area (CSA) - Biceps, Triceps, Brachialis, Antrerior Deltoid, Upper Trapezius, Rectus Abdominis
Time Frame: From baseline assessment to 8-week follow-up assessment.
Change in muscle CSA (cm²) for specified muscles combined or reported individually from baseline to 8-week follow-up as measured by diagnostic ultrasound.
From baseline assessment to 8-week follow-up assessment.
1-Repetition Maximum (1RM) - Bench Press and Triceps Push-Down
Time Frame: From baseline assessment to 8-week follow-up assessment.
Change in bench Press and triceps push-down 1RM (kg) from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment.
Shoulder Internal/External Rotation Strength
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in peak isometric rotation force (kg) for dominant and non-dominant shoulders (measured by handheld dynamometer, make test) from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment
Hand Grip Strength
Time Frame: From baseline assessment to 8-week follow-up assessment.
Change in maximal handgrip strength (kg) from baseline to 8-week follow-up measured with a calibrated dynamometer
From baseline assessment to 8-week follow-up assessment.
Upper-Body Muscular Endurance - Push-Up, Sit-Up, Pull-Up
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in number of repetitions to volitional fatigue for push-up, sit-up, and pull-up tests from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment
Serve Speed
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in maximum volleyball serve speed (km/h) from baseline to 8-week follow-up measured by radar.
From baseline assessment to 8-week follow-up assessment
Aerobic Intermittent Endurance - Yo-Yo IR1
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in Yo-Yo IR1 performance (VO2max) from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment
Anaerobic Power - Wingate Test
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in peak power and mean power (W and W·kg-¹) derived from the 30-s Wingate test from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment
Perceived Exertion - RPE (Borg 6-20)
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in session RPE (Borg 6-20 score), averaged across training sessions, from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment
Perceived Discomfort (RPD)
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in perceived discomfort scores (0-10 scale) for whole body and arm-specific measures from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment
Exercise Enjoyment (PACES)
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in exercise enjoyment score (8-item PACES, score range 1-7) from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment
OMNI-RES (Resistance Exercise Perceived Exertion)
Time Frame: From baseline assessment to 8-week follow-up assessment
Change in OMNI-RES average score (0-10) across sessions from baseline to 8-week follow-up.
From baseline assessment to 8-week follow-up assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anthropometric Measurements 1
Time Frame: Baseline
Participants' height (cm) will assess by using a stadiometer (Holtain Stadiometer, England).
Baseline
Anthropometric Measurements 2
Time Frame: Baseline
Body weight (kg) will asses by Inbody 270 (Biospace, California, USA)
Baseline
Anthropometric Measurements 3
Time Frame: Baseline
Body mass index (BMI) (kg/m2) will asses by Inbody 270 (Biospace, California, USA).
Baseline
Anthropometric Measurements 4
Time Frame: Baseline
Body fat percentage (%) will asses by Inbody 270 (Biospace, California, USA).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karabuk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Neslihan Akçay, Doctorate, Karabuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UKarabuk-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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