NCT05868304

Brief Summary

The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2023

Longer than P75 for not_applicable healthy

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

Study Start

First participant enrolled

February 8, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed
Last Updated

November 25, 2025

Status Verified

February 1, 2023

Enrollment Period

2.6 years

First QC Date

March 1, 2023

Last Update Submit

November 20, 2025

Conditions

Healthy

Keywords

Blood Flow Restriction (BFR)Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

  • The change in Force plate measures from baseline to 16 weeks

    Force (N)

    Measured at 4, 6, 8, 12, and 16 weeks.

  • The change in Force plate measures from baseline to 16 weeks

    Power (W)

    Measured at 4,6,8,12 and 16 weeks.

  • The change in Force plate measures from baseline to 16 weeks

    Velocity M/Se

    Measured at 4,6,8,12 and 16 weeks.

  • the changes in Force plate measures from baseline to 16 weeks

    Relative strength index (RSI)

    Measured at 4,6,8,12 and 16 weeks.

  • the change in Force plate measures from baseline to 16 weeks

    Displacement

    Measured at 4,6,8,12 and 16 weeks.

  • the changes in Force Frame measures from baseline to 16 weeks

    Force (N)

    Measured at 4,6,8,12 and 16 weeks.

  • the changes in Force Frame measures from baseline to 16 weeks

    power (W)

    Measured at 4,6,8,12 and 16 weeks.

  • the changes in Force Frame measure from baseline to 16 weeks

    Velocity M/sec

    Measured at 4,6,8,12 and 16 weeks.

Study Arms (2)

Group 1 - Standard strengthening group (no BFR)

ACTIVE COMPARATOR

Participants will warm up on a stationary bike for 5 minutes The program will consist of the following exercises using a 30,15,15,15 rep scheme: Banded squats Step ups (8 inch) Romanian dead lifts (RDL)

Other: Stanard strengthening program.

Group 2 - Low-load BFR group

EXPERIMENTAL

Participants will warm up on a stationary bike for 5 minutes BFR will be applied to non-dominant limb (dominant limb is determined as the preferred leg for kicking a ball) The program will consist of the following exercises using a 30,15,15,15 rep scheme: Banded squats Step ups (8 inch) Romanian dead lifts (RDL)

Device: BFROther: Stanard strengthening program.

Interventions

BFRDEVICE

Exercises may involve warm up on a stationary bike for 5 minutes, application of a BFR cuff (a cuff that often uses air to inflate around a limb) on the selected extremity, and exercise sets (e.g. banded squats, step ups, Romanian dead lifts). We will record metrics on an iPad. Testing will be done with ForceDecks and ForceFrames (system for measuring muscle strength and imbalance).

Group 2 - Low-load BFR group
Stanard strengthening program.OTHER

The exercise program will be completed 3 times per week Participants will warm up on a stationary bike for 5 minutes The program will consist of the following exercises using a 30,15,15,15 rep scheme: Banded squats Step ups (8 inch) Romanian dead lifts (RDL)

Group 1 - Standard strengthening group (no BFR)Group 2 - Low-load BFR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers without history of knee pathology requiring physical therapy or surgery
  • Individuals between 18 and 40 years old

You may not qualify if:

  • History of venous thromboembolism or other hematologic disorder Pregnant
  • Coronary artery disease, peripheral arterial disease, or hypertension (\> 140/90 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedar Sinai Kerlan jobe orthopedic institute

Los Angeles, California, 90035, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2023

First Posted

May 22, 2023

Study Start

February 8, 2023

Primary Completion

September 25, 2025

Study Completion

September 25, 2025

Last Updated

November 25, 2025

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)