NCT07309068

Brief Summary

Blood Flow Restriction Training (BFR) is a technique applied using a cuff or tourniquet to restrict venous return while maintaining arterial blood flow during exercise. In recent years, BFR has gained increasing attention as an effective method to enhance muscle activity with low-intensity training. This study aims to evaluate the acute effects of BFR training on a relatively underexplored area-balance and proprioception-and to analyze these effects by comparing them with sham and control groups. The study is planned to include healthy individuals aged 18-35 years. Participants will be divided into three groups: BFR, sham, and control. Before and after the exercise protocol, all participants' demographic information and physical activity levels will be recorded. In the next phase, participants will undergo assessments of static and dynamic balance, knee and ankle proprioception measurements, and single-leg hop tests. After completing a single-session exercise protocol, all assessment tests will be repeated for each participant. The collected data will be compared across groups. The expected outcome of the study is that the BFR group, in which arterial occlusion will be applied, will show significant improvements in parameters related to balance and proprioception compared to the other groups. The novelty of this study lies in examining both the effects of BFR on balance and proprioception and their acute-level manifestations. Currently, studies investigating the effects of BFR on balance and proprioception are limited. Our study aims not only to contribute to the diversity of literature on balance exercise applications but also, if the acute effects of BFR are confirmed, to provide a new perspective on the application of this exercise method in physiotherapy, rehabilitation, and sports sciences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 20, 2026

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 20, 2025

Last Update Submit

February 18, 2026

Conditions

Keywords

blood flow restrictionproprioceptiondynamic balance

Outcome Measures

Primary Outcomes (2)

  • Balance Assessments - Performanze Balance System

    Within the scope of this study, a Performanz electronic monitoring device, designed to analyze lower extremity muscle groups that influence human balance, will be used. The device operates based on a method that analyzes muscle contraction patterns by tracking the center of balance. Using this system, static single-leg balance will be assessed for both lower extremities under eyes-open conditions. During the test, participants will stand on the platform for 30 seconds, first on the right foot and then on the left foot, with the knee slightly flexed and the arms crossed over the trunk. Measurements will be repeated three times, and the device will provide the average of the three trials. The device operates in an integrated manner with a computer-based software system that enables the objective assessment of balance. Through this software, researchers will be able to monitor the measurements in real time using an Android-based tablet or a laptop computer. Balance performan

    pre-invention and immediatelety after invention

  • Dynamic Balance Assessments - Y Balance Test

    The Y Balance Test (YBT) will be administered in this study as a valid and reliable measurement method for the assessment of dynamic balance. Measurements will be conducted using a Y Balance Test platform. The YBT aims to assess the participant's ability to maintain balance on one leg while reaching as far as possible in three directions-anterior, posterolateral, and posteromedial-with the contralateral limb. Following test administration, the composite score will be calculated by normalizing the sum of the maximum reach distances in the three directions to the participant's lower extremity length. The YBT is widely used in the literature as a standardized test protocol with well-established validity and reliability for evaluating dynamic balance capacity (Shaffer, 2013).

    pre-invention and immediatelety after invention

Secondary Outcomes (4)

  • Proprioception - Joint Position Sense

    pre-invention and immediatelety after invention

  • Single Leg Hop Test

    pre-invention and immediatelety after invention

  • Physical Activity Level

    pre-invention and immediatelety after invention

  • Rating of Perceived Exertion

    pre-invention and immediatelety after invention

Study Arms (3)

Control group

OTHER
Other: Proprioceptive Exercise Training

Sham Group

SHAM COMPARATOR
Other: sham BFROther: Proprioceptive Exercise Training

BFR Group

EXPERIMENTAL
Other: BFROther: Proprioceptive Exercise Training

Interventions

BFROTHER

In this group, participants will have cuffs placed proximally on the limb to induce blood flow restriction, and individualized pressure will be applied. Participants will perform the prescribed exercises under blood flow restriction conditions. For the blood flow restriction application, an Occlusion Cuff device will be used. Following the warm-up protocol, cuffs will be placed bilaterally on the most proximal portion of the thigh in both the BFR and sham groups. The cuff tightness will be adjusted to allow the insertion of two fingers between the cuff and the skin at both the upper and lower edges. In the sham group, the cuffs will not be inflated to restrict blood flow, while in the BFR group, the pressure will be set at 80% of the individual's arterial occlusion pressure (AOP). AOP will be determined in the supine position using an Occlusion Cuff Doppler ultrasound device (8 MHz) applied to the posterior tibial artery.

BFR Group

Participants in the sham BFR group will wear cuffs placed proximally on both thighs. However, no pressure will be applied to restrict blood flow. The cuffs will remain in place throughout the exercise session to simulate the sensation of blood flow restriction without inducing actual occlusion. Participants will perform the same exercise protocol as the BFR group under these conditions.

Sham Group

All participants will perform the same exercise protocol. The protocol was designed based on studies in the literature examining the effects of proprioception training. The program consists of various balance and proprioceptive exercises performed on a BOSU balance platform. The purpose of the exercises is to improve participants' static and dynamic balance, stimulate the sensorimotor system, and enhance lower extremity stability. The exercise protocol includes the following sequence: participants will perform squats on the BOSU (10 repetitions), double-leg stance on the BOSU (60 seconds), double-leg ball toss and catch on the BOSU (60 seconds), single-leg stance on the BOSU (60 seconds), and single-leg ball toss and catch on the BOSU (60 seconds). This is followed by double-leg jumps on the BOSU (10 repetitions), single-leg jumps on the BOSU (10 repetitions), and double-leg jumps with 90° trunk rotation on the BOSU (10 repetitions). In the final part, participants will perform double

BFR GroupControl groupSham Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be male or female between 18 and 35 years of age.
  • Have a physical activity level defined as an energy expenditure of at least 600 MET-minutes per week, according to the International Physical Activity -Questionnaire - Short Form (IPAQ-SF).
  • Have normal knee joint range of motion (flexion: 0-135°; hyperextension: 0-10°).
  • Have normal ankle joint range of motion (dorsiflexion: 0-20°; plantarflexion: 0-45°).

You may not qualify if:

  • History of low back or lower extremity injury within the past 6 months.
  • History of neurological or vestibular disorders.
  • History of lower extremity surgery.
  • Risk factors for deep vein thrombosis.
  • Presence of at least one contraindication preventing participation in exercises involving blood flow restriction (e.g., smoking, previous venous thromboembolism, peripheral vascular disease risk such as ankle-brachial index \<0.9, coronary heart disease, hypertension, hemophilia, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Related Publications (20)

  • Wong V, Spitz RW, Song JS, Yamada Y, Kataoka R, Hammert WB, Kang A, Seffrin A, Bell ZW, Loenneke JP. Blood flow restriction augments the cross-education effect of isometric handgrip training. Eur J Appl Physiol. 2024 May;124(5):1575-1585. doi: 10.1007/s00421-023-05386-y. Epub 2024 Jan 2.

  • Takarada Y, Nakamura Y, Aruga S, Onda T, Miyazaki S, Ishii N. Rapid increase in plasma growth hormone after low-intensity resistance exercise with vascular occlusion. J Appl Physiol (1985). 2000 Jan;88(1):61-5. doi: 10.1152/jappl.2000.88.1.61.

  • Pope ZK, Willardson JM, Schoenfeld BJ. Exercise and blood flow restriction. J Strength Cond Res. 2013 Oct;27(10):2914-26. doi: 10.1519/JSC.0b013e3182874721.

  • Pearson SJ, Hussain SR. A review on the mechanisms of blood-flow restriction resistance training-induced muscle hypertrophy. Sports Med. 2015 Feb;45(2):187-200. doi: 10.1007/s40279-014-0264-9.

  • Pavlou K, Korakakis V, Whiteley R, Karagiannis C, Ploutarchou G, Savva C. The effects of upper body blood flow restriction training on muscles located proximal to the applied occlusive pressure: A systematic review with meta-analysis. PLoS One. 2023 Mar 23;18(3):e0283309. doi: 10.1371/journal.pone.0283309. eCollection 2023.

  • Neto GR, Novaes JS, Dias I, Brown A, Vianna J, Cirilo-Sousa MS. Effects of resistance training with blood flow restriction on haemodynamics: a systematic review. Clin Physiol Funct Imaging. 2017 Nov;37(6):567-574. doi: 10.1111/cpf.12368. Epub 2016 Apr 20.

  • Loenneke JP, Wilson GJ, Wilson JM. A mechanistic approach to blood flow occlusion. Int J Sports Med. 2010 Jan;31(1):1-4. doi: 10.1055/s-0029-1239499. Epub 2009 Nov 2.

  • Lippi L, Turco A, Folli A, Vicelli F, Curci C, Ammendolia A, de Sire A, Invernizzi M. Effects of blood flow restriction on spine postural control using a robotic platform: A pilot randomized cross-over study. J Back Musculoskelet Rehabil. 2023;36(6):1447-1459. doi: 10.3233/BMR-230063.

  • Laurin J, Pertici V, Dousset E, Marqueste T, Decherchi P. Group III and IV muscle afferents: role on central motor drive and clinical implications. Neuroscience. 2015 Apr 2;290:543-51. doi: 10.1016/j.neuroscience.2015.01.065. Epub 2015 Feb 7.

  • Labata-Lezaun N, Llurda-Almuzara L, Lopez-de-Celis C, Rodriguez-Sanz J, Gonzalez-Rueda V, Hidalgo-Garcia C, Muniz-Pardos B, Perez-Bellmunt A. Effectiveness of Protein Supplementation Combined with Resistance Training on Muscle Strength and Physical Performance in Elderly: A Systematic Review and Meta-Analysis. Nutrients. 2020 Aug 27;12(9):2607. doi: 10.3390/nu12092607.

  • Korkmaz Dayican D, Ulker Eksi B, Yigit S, Utku Umut G, Ozyurek B, Yilmaz HE, Akinci B. Immediate Effects of High-Intensity Blood Flow Restriction Training on Muscle Performance and Muscle Soreness. Res Q Exerc Sport. 2025 Mar;96(1):213-222. doi: 10.1080/02701367.2024.2389902. Epub 2024 Aug 26.

  • Hwang PS, Willoughby DS. Mechanisms Behind Blood Flow-Restricted Training and its Effect Toward Muscle Growth. J Strength Cond Res. 2019 Jul;33 Suppl 1:S167-S179. doi: 10.1519/JSC.0000000000002384.

  • Henry M, Baudry S. Age-related changes in leg proprioception: implications for postural control. J Neurophysiol. 2019 Aug 1;122(2):525-538. doi: 10.1152/jn.00067.2019. Epub 2019 Jun 5.

  • Hadadi M, Haghighat F, Sobhani S. Can fibular reposition taping improve balance performance in individuals with chronic ankle instability? A randomized controlled trial. Musculoskelet Sci Pract. 2020 Apr;46:102128. doi: 10.1016/j.msksp.2020.102128. Epub 2020 Feb 4.

  • Goble DJ. Proprioceptive acuity assessment via joint position matching: from basic science to general practice. Phys Ther. 2010 Aug;90(8):1176-84. doi: 10.2522/ptj.20090399. Epub 2010 Jun 3.

  • Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.

  • Freitas EDS, Karabulut M, Bemben MG. The Evolution of Blood Flow Restricted Exercise. Front Physiol. 2021 Dec 2;12:747759. doi: 10.3389/fphys.2021.747759. eCollection 2021.

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  • Cho C, Lee S. The Effects of Blood Flow Restriction Aerobic Exercise on Body Composition, Muscle Strength, Blood Biomarkers, and Cardiovascular Function: A Narrative Review. Int J Mol Sci. 2024 Aug 27;25(17):9274. doi: 10.3390/ijms25179274.

  • Bennett H, Slattery F. Effects of Blood Flow Restriction Training on Aerobic Capacity and Performance: A Systematic Review. J Strength Cond Res. 2019 Feb;33(2):572-583. doi: 10.1519/JSC.0000000000002963.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant professor

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 30, 2025

Study Start

November 1, 2025

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

February 20, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
18.02.2026 - 18.02.2027

Locations