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Blood-Flow Restriction Exercise Following a Knee Replacement

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ClinicalTrials.gov Identifier: NCT04018638
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Steve Elmer, Michigan Technological University

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).

Condition or disease Intervention/treatment Phase
Knee Injuries Knee Osteoarthritis Knee Arthritis Other: B-FREE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : June 25, 2020
Estimated Study Completion Date : June 25, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in Muscle size [ Time Frame: Change from baseline at 10 weeks ]
    quadriceps muscle thickness

  2. Change in Muscle strength [ Time Frame: Change from baseline at 10 weeks ]
    quadriceps muscle strength


Secondary Outcome Measures :
  1. Change in Walking performance [ Time Frame: Change from baseline at 10 weeks ]
    walking distance

  2. Change in Balance [ Time Frame: Change from baseline at 10 weeks ]
    balance assessment



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018638


Contacts
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Contact: Christina Lehmann 9064871295 cmlehmann@mtu.edu

Locations
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United States, Michigan
Michigan Technological University Recruiting
Houghton, Michigan, United States, 49931
Contact: Steven Elmer    906-487-2324    sjelmer@mtu.edu   
Sponsors and Collaborators
Michigan Technological University
Blue Cross Blue Shield of Michigan Foundation
Investigators
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Principal Investigator: Steven Elmer Michigan Technological University

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Responsible Party: Steve Elmer, Principal Investigator, Michigan Technological University
ClinicalTrials.gov Identifier: NCT04018638     History of Changes
Other Study ID Numbers: MichiganTU
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Knee Injuries
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Leg Injuries
Wounds and Injuries