BFR Training on Muscle Morphology

Effectiveness of Blood Flow Restriction Training on Muscle Morphology and Prevention of Patellofemoral Pain Syndrome and Anterior Cruciate Ligament Injury

This randomized clinical trial study compares high-load eccentric training (HL-Et), sham LL-BFRt, and low-load blood flow restriction (LL-BFRt) in sportsmen. The primary inquiries it seeks to address are:

Is LL-BFR superior to HL-Et and sham LL-BFRt in terms of improving muscle morphology? Is LL-BFR a more effective Patellofemoral Pain Syndrome and ACL injury preventive than HL-Et and sham LL-BFRt?

The three intervention groups that will be randomly assigned to participants are LL-BFRt, sham LL-BFRt, and HL-Et. Participants are expected to carry out:

Participants in LL-BFRt will be required to perform LL eccentric training at 30% of their repetition maximum (RM) and 70% of their artery occlusion pressure (AOP). This training will include stairs, single leg squat, and single leg deadlift.

Participants in HL-Et will be required to perform LL eccentric training at 70% of their maximum number of repetitions (RM).

In order to determine whether muscular morphology and the prevention of Patellofemoral Pain Syndrome and ACL injury improve following the interventions and follow-up, researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Patellofemoral Pain Syndrome; Blood Flow Restriction Training; Eccentric Training; Muscle Morphology
• Intervention / Treatment: Procedure: Low load-BFRt; Procedure: Sham Low load-BFRt; Procedure: High load-Eccentric training

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: I Putu Gde Surya Adhitya, PhD; Phone Number: +6288975003567; Email: surya_adhitya@unud.ac.id

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80232
      • Recruiting
      • Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar
      • Contact: I Putu Gde Surya Adhitya, PhD; Phone Number: +6288975003567; Email: surya_adhitya@unud.ac.id

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Being between the ages of 15 and 35
• Play level 1 sports (fight martial arts, basketball, futsal, and soccer) at least twice a week
• Never experienced an Patellofemoral Pain Syndrome or ACL injury before
• Never experienced a grade III sprain or strain
• Consent to participate in the study until its conclusion and provide informed consent.

Exclusion Criteria:

• Having a tumor, cancer, vena thromboembolic disease, obesity, diabetes, hypertension, anemia, and renal failure
• Disabilities or those who are disabled.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low load-BFRt; 70% of the arterial occlusion pressure and 30% of the maximum repetition rate	Procedure: Low load-BFRt; The participants' two legs will be subjected to 70% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as stairs, single leg squat, and single leg deadlift.
Sham Comparator: Sham Low load-BFRt; 10% of the arterial occlusion pressure and 30% of the maximum repetition rate	Procedure: Sham Low load-BFRt; The participants' two legs will be subjected to 10% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as stairs, single leg squat, and single leg deadlift.
Active Comparator: High load-Eccentric training; 70% of the maximum repetition rate	Procedure: High load-Eccentric training; The physical therapist will instruct the participants to complete eccentric exercises at a maximum of 70% repetitions, such as stairs, single leg squat, and single leg deadlift.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle cross-sectional area	Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and peroneus longus muscle.	8 weeks
Vastus medial obliques fiber angle	Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle.	8 weeks
Patella position	Using a musculoskeletal ultrasonography, researchers will determine the patella position.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of patellofemoral pain syndrome	Researchers will determine the incidence of patellofemoral pain syndrome with the physical examination of grind test.	1 year
Incidence of anterior cruciate ligament injury	Researchers will determine the incidence of anterior cruciate ligament injury with the physical examination of Lachman's test.	1 year

Collaborators and Investigators

• Sponsor: Udayana University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): November 20, 2024
• Study Completion (Estimated): November 20, 2025

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

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

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Joint Diseases; Disease; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Syndrome; Patellofemoral Pain Syndrome
• Other Study ID Numbers: 1791/UN14.2.2.VII.14/LT.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No