Blood-Flow Restriction Exercise Following a Knee Replacement

Michigan Technological University

Status: Active, not recruiting

Conditions: Knee Injuries; Knee Arthritis; Knee Osteoarthritis

Treatments: Other: B-FREE

Study type: Interventional

Funder types: Other

Identifiers

NCT04018638

MichiganTU

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Adults with TKR Perform Home Exercise Program

Experimental group

Description:

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

Treatment:

Other: B-FREE

Healthy Controls Only

No Intervention group

Description:

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