Back to resultsBlood-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
About this trial
This is an interventional treatment trial for Knee Injuries
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
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
NCT ID
NCT04018638
First Posted
July 10, 2019
Last Updated
March 13, 2023
Sponsor
Michigan Technological University
Collaborators
Blue Cross Blue Shield of Michigan Foundation
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
Learn more about this trial
Blood-Flow Restriction Exercise Following a Knee Replacement
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