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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951036
• Other study ID #: 1575/UN14.2.2.VII.14/LT/2023
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: Udayana University
• Contact: I Putu Gde Surya Adhitya, PhD
• Phone: +6288975003567
• Email: surya_adhitya[@]unud.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Healthy Subjects

Intervention

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 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.
• 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.

Locations

Country	Name	City	State
Indonesia	Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar	Denpasar	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

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