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

• Sponsor: Udayana University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05951036
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 16.5
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects; Sports Level 1	Procedure: Low-load Blood Flow Restriction training; Procedure: Sham Low-load Blood Flow Restriction training; Procedure: High-load Eccentric training	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: 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
• Anticipated Study Start Date: Jul 17, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LL-BFRt 30% of repetition maximum and 70% of arterial occlusion pressure	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 Comparator: Sham LL-BFRt 30% of repetition maximum and 10% of arterial occlusion pressure	Procedure: 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.
Active Comparator: HL-Et 70% of repetition maximum	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. Muscle strength [8 weeks]

   Investigators will measure the quadriceps muscle isometric strength using dynamometer (units: Newton or kilogram).

2. Dynamic stability I [8 weeks]

   Investigators will measure the dynamic stability I using Y-balance test (units: centimeter).

3. Dynamic stability II [8 weeks]

   Investigators will measure the dynamic stability II using single leg hop test (units: centimeter).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar	Denpasar	Bali	Indonesia	80232

Sponsors and Collaborators

• Udayana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: I Putu Gde Surya Adhitya, Principal Investigator, Udayana University
• ClinicalTrials.gov Identifier: NCT05951036
• Other Study ID Numbers: 1575/UN14.2.2.VII.14/LT/2023
• First Posted: Jul 18, 2023
• Last Update Posted: Jul 18, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by I Putu Gde Surya Adhitya, Principal Investigator, Udayana University: blood flow restriction training; sham blood flow restriction training; BFR; Eccentric training
• Additional relevant MeSH terms: Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Jul 18, 2023