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Clinical Trials/NCT05951036
NCT05951036
Completed
Not Applicable

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

Udayana University1 site in 1 country60 target enrollmentJuly 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Subjects
Sponsor
Udayana University
Enrollment
60
Locations
1
Primary Endpoint
Dynamic stability I
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2023
End Date
November 30, 2024
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Udayana University
Responsible Party
Principal Investigator
Principal Investigator

I Putu Gde Surya Adhitya

Principal Investigator

Udayana University

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.

Outcomes

Primary Outcomes

Dynamic stability I

Time Frame: 8 weeks

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

Muscle strength

Time Frame: 8 weeks

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

Dynamic stability II

Time Frame: 8 weeks

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

Study Sites (1)

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