Effect of Blood Flow Restriction Training to Muscle Strength, Dynamic Stability, and ACL Injury Prevention

Effects of Additional Blood Flow Restriction and Sham Blood Flow Restriction in Eccentric Exercise on Muscle Strength, Dynamic Stability, and Reduce the Risk of ACL Injury

The goal of this randomized clinical trial study is to compare low-load blood flow restriction (LL-BFRt), sham LL-BFRt, and high-load eccentric training (HL-Et) in healthy level 1 sportsman. The main questions it aims to answer are:

1. Does LL-BFR improve muscle strength better than sham LL-BFRt and HL-Et?
2. Does LL-BFR improve dynamic stability better than sham LL-BFRt and HL-Et?
3. Does LL-BFR prevent ACL injury better than sham LL-BFRt and HL-Et?

Participants will be randomized into three intervention groups: LL-BFRt, sham LL-BFRt, and HL-Et. Participants will be asked to do:

• In LL-BFRt, participants will be asked to do LL eccentric training (including double leg squats, split squats, deadlifts, and monster walks) with a 30% of repetition maximum (RM) and 70% of arterial occlusion pressure (AOP).
• In sham LL-BFRt, participants will be asked to do LL eccentric training with a 30% of repetition maximum (RM) and 10% of arterial occlusion pressure (AOP).
• In HL-Et, participants will be asked to do LL eccentric training with a 70% of repetition maximum (RM).

Researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et to see if muscle strength, dynamic stability, and ACL injury prevention improve after the interventions and follow-up.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Sports Level 1
• Intervention / Treatment: Procedure: Low-load Blood Flow Restriction training; Procedure: Sham Low-load Blood Flow Restriction training; Procedure: High-load Eccentric training

Detailed Description

Participants will be asked to do five sets of ten repetitions of each eccentric training, one-minute rest interval for each eccentric training and two mins rest interval between each set.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80232
      • Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being 15-35 years old
• Perform sports level 1 (soccer, basket ball, futsal, combat martial art) at least twice per week.
• Never had an history of ACL injury
• Never had an history of sprain or strain grade III
• Agree to participate until the end of this study period and sign the inform consent

Exclusion Criteria:

• Having hypertension, blood circulation disease, anemia, obesity, diabetes, kidney failure, vena thromboembolic, cancer, and tumor.
• Disabilities or disabled people.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LL-BFRt; 30% of repetition maximum and 70% of arterial occlusion pressure	Procedure: Low-load Blood Flow Restriction training; Physical therapist will apply the BFR cuffs with 70% of arterial occlusion pressure on the both legs of participants. Then, participants will be asked to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 30% of repetition maximum.
Sham Comparator: Sham LL-BFRt; 30% of repetition maximum and 10% of arterial occlusion pressure	Procedure: Sham Low-load Blood Flow Restriction training; Physical therapist will apply the BFR cuffs with 10% of arterial occlusion pressure on the both legs of participants. Then, participants will be asked to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 30% of repetition maximum.
Active Comparator: HL-Et; 70% of repetition maximum	Procedure: High-load Eccentric training; Physical therapist will ask participants to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 70% of repetition maximum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Investigators will measure the quadriceps muscle isometric strength using dynamometer (units: Newton or kilogram).	8 weeks
Dynamic stability I	Investigators will measure the dynamic stability I using Y-balance test (units: centimeter).	8 weeks
Dynamic stability II	Investigators will measure the dynamic stability II using single leg hop test (units: centimeter).	8 weeks

Collaborators and Investigators

• Sponsor: Udayana University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: July 2, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: blood flow restriction training; BFR; Eccentric training; sham blood flow restriction training
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 1575/UN14.2.2.VII.14/LT/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No