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Active, not recruitingNCT04018638Updated Jul 15, 2026

Blood-Flow Restriction Exercise Following a Knee Replacement

An interventional study of B-FREE in Knee Injuries, Knee Osteoarthritis and Knee Arthritis, sponsored by Michigan Technological University. Active, not recruiting at 1 site in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Michigan Technological University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR).

Read the detailed description

This study aims to determine the safety and efficacy of using B-FREE to overcome persistent quadriceps muscle weakness that occurs following a TKR. We hypothesize that B-FREE can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. Specifically, subjects that have a TKR will perform B-FREE at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. Quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. Changes in these variables will be compared to healthy age-matched uninjured controls.

02

Conditions studied

  • Knee Injuries
  • Knee Osteoarthritis
  • Knee Arthritis
03

In context

Knee Injuries

249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

Michigan Technological University is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 40-75 years of age
  • Have had a unilateral TKA > 6 months prior to participation (Arm 1)
  • No previous history of knee injury/surgery (Arm 2)

Exclusion criteria

Exclusion Criteria

  • Are a smoker
  • Have diabetes
  • Have suffered a heart attack or stroke
  • Have any cardiopulmonary disorders (hypertension discussed below)
  • Have been diagnosed with any neurological disorders
  • Have any implanted devices such as but not limited to a pacemaker or pain pump
  • Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Adults with TKR Perform Home Exercise Program

    Participants that have a total knee replacement will complete a home-based exercise program

    Other: B-FREE

  • No intervention
    Healthy Controls Only

    Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls

Interventions

  • OtherB-FREE

    Blood flow-restriction exercise enhancement (B-FREE) will be performed at home 3x/wk for 10 weeks. A blood pressure cuff will be inflated to partially occlude blood to the limb during light weight exercises involving knee extension, body weight squats, and walking.

06

What researchers measure

Primary outcomes

  1. Change in Muscle size

    quadriceps muscle thickness

    Time frame: Change from baseline at 10 weeks

  2. Change in Muscle strength

    quadriceps muscle strength

    Time frame: Change from baseline at 10 weeks

Secondary outcomes

  1. Change in Walking performance

    walking distance

    Time frame: Change from baseline at 10 weeks

  2. Change in Balance

    balance assessment

    Time frame: Change from baseline at 10 weeks

07

Study locations

1 site
  • Michigan Technological University
    Houghton, Michigan 49931, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04018638
Lead sponsor
Michigan Technological University
Collaborators
Blue Cross Blue Shield of Michigan Foundation
Responsible party
Sponsor
First posted
Jul 12, 2019
Start date
Jun 25, 2019
Primary completion
Dec 25, 2027 (estimated)
Completion
Dec 25, 2027 (estimated)
Last update
Jul 15, 2026

Study contacts

Steven Elmer
principal investigator · Michigan Technological University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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