Blood-Flow Restriction Exercise Following a Knee Replacement

B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04018638

Enrollment

Registered

2019-07-12

Start date

2019-06-25

Completion date

2027-12-25

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthritis, Knee Injuries, Knee Osteoarthritis

Brief 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).

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.

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in Muscle size	Change from baseline at 10 weeks	quadriceps muscle thickness
Change in Muscle strength	Change from baseline at 10 weeks	quadriceps muscle strength

Secondary

Measure	Time frame	Description
Change in Walking performance	Change from baseline at 10 weeks	walking distance
Change in Balance	Change from baseline at 10 weeks	balance assessment

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSteven Elmer

Michigan Technological University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026