NCT05951036

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

July 2, 2023

Last Update Submit

June 27, 2025

Conditions

Keywords

blood flow restriction trainingsham blood flow restriction trainingBFREccentric training

Outcome Measures

Primary Outcomes (3)

  • Muscle strength

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

    8 weeks

  • Dynamic stability I

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

    8 weeks

  • Dynamic stability II

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

    8 weeks

Study Arms (3)

LL-BFRt

EXPERIMENTAL

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

Procedure: Low-load Blood Flow Restriction training

Sham LL-BFRt

SHAM COMPARATOR

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

Procedure: Sham Low-load Blood Flow Restriction training

HL-Et

ACTIVE COMPARATOR

70% of repetition maximum

Procedure: High-load Eccentric training

Interventions

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.

LL-BFRt

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.

Sham LL-BFRt

Physical therapist will ask participants to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 70% of repetition maximum.

HL-Et

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Having hypertension, blood circulation disease, anemia, obesity, diabetes, kidney failure, vena thromboembolic, cancer, and tumor.
  • Disabilities or disabled people.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Denpasar, Bali, 80232, Indonesia

Location

Related Publications (1)

  • Adhitya IPGS, Aryana IGNW, Kurniawati I, Thanaya SAP, Utama MBR. Effect of Low-Load Blood Flow Restriction Training and High-Load Resistance Training on Quadriceps Strength, Dynamic Stability, and Functional Performance. Clin J Sport Med. 2025 Feb 11. doi: 10.1097/JSM.0000000000001330. Online ahead of print.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2023

First Posted

July 18, 2023

Study Start

July 17, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2024

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations