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Blood-Flow Restriction Exercise for Knee Replacement

N/A
Waitlist Available
Led By Steven Elmer
Research Sponsored by Michigan Technological University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No previous history of knee injury/surgery (Arm 2)
40-75 years of age
Must not have
Have suffered a heart attack or stroke
Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 10 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if using a B-FREE device to restrict blood flow during exercise is safe and effective in improving quadriceps muscle weakness following a TKR.

Who is the study for?
This trial is for adults aged 40-75 who have had a knee replacement over 6 months ago and haven't had previous knee injuries or surgeries. It's not for those with diabetes, heart conditions, neurological disorders, certain implanted devices, uncontrolled high blood pressure, or smokers.
What is being tested?
The study tests the B-FREE method to see if it helps strengthen thigh muscles after total knee replacement surgery. Participants will use this exercise technique designed to improve muscle strength by restricting blood flow during exercise.
What are the potential side effects?
While specific side effects are not listed, blood-flow restriction exercises may cause discomfort in the limb due to pressure from bands used to restrict blood flow and potential muscle soreness from exercising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had a knee injury or surgery.
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I am between 40 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a heart attack or stroke.
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I have high blood pressure that is not controlled by medication.
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I have diabetes.
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I have a heart or lung condition.
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I have been diagnosed with a neurological disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Muscle size
Change in Muscle strength
Secondary study objectives
Change in Balance
Change in Walking performance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adults with TKR Perform Home Exercise ProgramExperimental Treatment1 Intervention
Participants that have a total knee replacement will complete a home-based exercise program
Group II: Healthy Controls OnlyActive Control1 Intervention
Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls

Find a Location

Who is running the clinical trial?

Michigan Technological UniversityLead Sponsor
5 Previous Clinical Trials
667 Total Patients Enrolled
Blue Cross Blue Shield of Michigan FoundationOTHER
27 Previous Clinical Trials
51,170 Total Patients Enrolled
Steven ElmerPrincipal InvestigatorMichigan Technological University

Media Library

B-FREE (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04018638 — N/A
Knee Injuries Research Study Groups: Healthy Controls Only, Adults with TKR Perform Home Exercise Program
Knee Injuries Clinical Trial 2023: B-FREE Highlights & Side Effects. Trial Name: NCT04018638 — N/A
B-FREE (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04018638 — N/A
~5 spots leftby Dec 2025
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