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Blood-Flow Restriction Exercise Following a Knee Replacement

Primary Purpose

Knee Injuries, Knee Osteoarthritis, Knee Arthritis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
B-FREE
Sponsored by
Michigan Technological University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Michigan Technological University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adults with TKR Perform Home Exercise Program

Healthy Controls Only

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Muscle size
quadriceps muscle thickness
Change in Muscle strength
quadriceps muscle strength

Secondary Outcome Measures

Change in Walking performance
walking distance
Change in Balance
balance assessment

Full Information

First Posted
July 10, 2019
Last Updated
March 13, 2023
Sponsor
Michigan Technological University
Collaborators
Blue Cross Blue Shield of Michigan Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04018638
Brief Title
Blood-Flow Restriction Exercise Following a Knee Replacement
Official Title
B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
July 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Michigan Technological University
Collaborators
Blue Cross Blue Shield of Michigan Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Knee Osteoarthritis, Knee Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults with TKR Perform Home Exercise Program
Arm Type
Experimental
Arm Description
Participants that have a total knee replacement will complete a home-based exercise program
Arm Title
Healthy Controls Only
Arm Type
No Intervention
Arm Description
Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls
Intervention Type
Other
Intervention Name(s)
B-FREE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Muscle size
Description
quadriceps muscle thickness
Time Frame
Change from baseline at 10 weeks
Title
Change in Muscle strength
Description
quadriceps muscle strength
Time Frame
Change from baseline at 10 weeks
Secondary Outcome Measure Information:
Title
Change in Walking performance
Description
walking distance
Time Frame
Change from baseline at 10 weeks
Title
Change in Balance
Description
balance assessment
Time Frame
Change from baseline at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Elmer
Organizational Affiliation
Michigan Technological University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Technological University
City
Houghton
State/Province
Michigan
ZIP/Postal Code
49931
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood-Flow Restriction Exercise Following a Knee Replacement

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