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

Not Applicable

Recruiting

• Conditions: Healthy Subjects; Sports Level 1
• Interventions: Procedure: High-load Eccentric training; Procedure: Sham Low-load Blood Flow Restriction training; Procedure: Low-load Blood Flow Restriction training

• Registration Number: NCT05951036
• Lead Sponsor: Udayana University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-07-02
• Study First Submitted QC: 2023-07-10
• Study Start: 2023-07-17
• Study First Posted: 2023-07-18
• Primary Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-06
• Last Update Posted: 2024-01-09
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HL-Et	High-load Eccentric training	70% of repetition maximum
Sham LL-BFRt	Sham Low-load Blood Flow Restriction training	30% of repetition maximum and 10% of arterial occlusion pressure
LL-BFRt	Low-load Blood Flow Restriction training	30% of repetition maximum and 70% of arterial occlusion pressure

Primary Outcome Measures

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

Trial Locations

Locations (1)

Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar; 🇮🇩 Denpasar, Bali, Indonesia