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

Primary Purpose

Healthy Subjects, Sports Level 1

Status
Not yet recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Low-load Blood Flow Restriction training
Sham Low-load Blood Flow Restriction training
High-load Eccentric training
Sponsored by
Udayana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Subjects focused on measuring blood flow restriction training, sham blood flow restriction training, BFR, Eccentric training

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

LL-BFRt

Sham LL-BFRt

HL-Et

Arm Description

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

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

70% of repetition maximum

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 2, 2023
Last Updated
July 10, 2023
Sponsor
Udayana University
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1. Study Identification

Unique Protocol Identification Number
NCT05951036
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 17, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Udayana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: Does LL-BFR improve muscle strength better than sham LL-BFRt and HL-Et? Does LL-BFR improve dynamic stability better than sham LL-BFRt and HL-Et? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Sports Level 1
Keywords
blood flow restriction training, sham blood flow restriction training, BFR, Eccentric training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LL-BFRt
Arm Type
Experimental
Arm Description
30% of repetition maximum and 70% of arterial occlusion pressure
Arm Title
Sham LL-BFRt
Arm Type
Sham Comparator
Arm Description
30% of repetition maximum and 10% of arterial occlusion pressure
Arm Title
HL-Et
Arm Type
Active Comparator
Arm Description
70% of repetition maximum
Intervention Type
Procedure
Intervention Name(s)
Low-load Blood Flow Restriction training
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Low-load Blood Flow Restriction training
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
High-load Eccentric training
Intervention Description
Physical therapist will ask participants to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 70% of repetition maximum.
Primary Outcome Measure Information:
Title
Muscle strength
Description
Investigators will measure the quadriceps muscle isometric strength using dynamometer (units: Newton or kilogram).
Time Frame
8 weeks
Title
Dynamic stability I
Description
Investigators will measure the dynamic stability I using Y-balance test (units: centimeter).
Time Frame
8 weeks
Title
Dynamic stability II
Description
Investigators will measure the dynamic stability II using single leg hop test (units: centimeter).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I Putu Gde Surya Adhitya, PhD
Phone
+6288975003567
Email
surya_adhitya@unud.ac.id
Facility Information:
Facility Name
Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar
City
Denpasar
State/Province
Bali
ZIP/Postal Code
80232
Country
Indonesia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I Putu Gde Surya Adhitya, PhD
Phone
+6288975003567

12. IPD Sharing Statement

Learn more about this trial

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

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