Clinical trial NCT05951036: Effect of Blood Flow Restriction Training to Muscle Strength, Dynamic Stability, and ACL Injury Prevention
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Subjects
Sports Level 1
Keywords: blood flow restriction training
sham blood flow restriction training
BFR
Eccentric training
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle strength
timeFrame: 8 weeks
measure: Dynamic stability I
timeFrame: 8 weeks
measure: Dynamic stability II
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar
state: Bali
Study officials:
References: