BFR Training on Muscle Morphology

NCT06566950 | Recruiting

• 1 other identifier: 1791/UN14.2.2.VII.14/LT.2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Flow Restriction Training; Eccentric Training; Muscle Morphology; Patellofemoral Pain Syndrome; Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Incidence of patellofemoral pain syndrome

  1 year

• Incidence of anterior cruciate ligament injury

  1 year

Study Arms (3)

Low load-BFRt

EXPERIMENTAL

70% of the arterial occlusion pressure and 30% of the maximum repetition rate

Procedure: Low load-BFRt

Sham Low load-BFRt

SHAM COMPARATOR

10% of the arterial occlusion pressure and 30% of the maximum repetition rate

Procedure: Sham Low load-BFRt

High load-Eccentric training

ACTIVE COMPARATOR

70% of the maximum repetition rate

Procedure: High load-Eccentric training

Interventions

Low load-BFRt PROCEDURE

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.

Low load-BFRt

Sham Low load-BFRt PROCEDURE

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.

Sham Low load-BFRt

High load-Eccentric training PROCEDURE

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.

High load-Eccentric training

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar

Denpasar, Bali, 80232, Indonesia

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

I Putu Gde Surya Adhitya, PhD

CONTACT

+6288975003567; surya_adhitya@unud.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 22, 2024
• Study Start: September 20, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)