Blood-Flow Restriction Exercise Following a Knee Replacement

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Knee Injuries, Knee Osteoarthritis, Knee Arthritis

Intervention / Treatment
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* Other: B-FREE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults with TKR Perform Home Exercise Program<br>Participants that have a total knee replacement will complete a home-based exercise program | Other: B-FREE<br>* 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.<br>|
| No Intervention: Healthy Controls Only<br>Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle size | quadriceps muscle thickness | Change from baseline at 10 weeks | 
| Change in Muscle strength | quadriceps muscle strength | Change from baseline at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Walking performance | walking distance | Change from baseline at 10 weeks | 
| Change in Balance | balance assessment | Change from baseline at 10 weeks |