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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis; Knee Injuries; Knee Arthritis
• Intervention / Treatment: Other: B-FREE

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Director, Human Research Protections; Phone Number: 906-487-2902; Email: irb@mtu.edu

Study Locations

• United States
  • Michigan
    • Houghton, Michigan, United States, 49931
      • Michigan Technological University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
No Intervention: Healthy Controls Only; Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Michigan Technological University
• Collaborators: Blue Cross Blue Shield of Michigan Foundation
• Investigators: Principal Investigator: Steven Elmer, Michigan Technological University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Anticipated): December 25, 2023
• Study Completion (Anticipated): July 25, 2024

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Knee Injuries
• Other Study ID Numbers: MichiganTU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No