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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
40-75 years of age
No previous history of knee injury/surgery (Arm 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 10 weeks
Awards & highlights
No Placebo-Only Group

Study 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.Check my eligibility
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.See study design
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 am between 40 and 75 years old.
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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.
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I had knee replacement surgery on one side more than 6 months ago.
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I have never had a knee injury or surgery.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Muscle size
Change in Muscle strength
Secondary outcome measures
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?

Blue Cross Blue Shield of Michigan FoundationOTHER
26 Previous Clinical Trials
51,108 Total Patients Enrolled
1 Trials studying Osteoarthritis
40 Patients Enrolled for Osteoarthritis
Michigan Technological UniversityLead Sponsor
5 Previous Clinical Trials
667 Total Patients Enrolled
Steven ElmerPrincipal InvestigatorMichigan Technological University

Media Library

B-FREE (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04018638 — N/A
Osteoarthritis Research Study Groups: Healthy Controls Only, Adults with TKR Perform Home Exercise Program
Osteoarthritis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to enroll in this research trial?

"According to the clinicaltrials.gov website, this clinical trial is actively seeking out participants. It was first advertised on June 25th 2019 and most recently updated August 30th 2021."

Answered by AI

How many participants are being enrolled in this experiment?

"Indeed, according to the information hosted on clinicaltrials.gov, this clinical trial is presently recruiting participants; it was first posted on June 25th 2019 and last edited in August 2021. The study requires 30 volunteers from a single location."

Answered by AI

Am I eligible to participate in this medical experiment?

"This clinical trial is welcoming 30 volunteers aged between 40 and 75 who have suffered a knee injury. The selection criteria also requires that they are older than forty, had their total knee arthroplasty (TKA) over six months ago (Arm 1), with no prior surgical or medical history related to the knee joint (Arm 2)."

Answered by AI

Does this research study accommodate people aged 85 and older?

"The age range for enrolment in this trial is 40 to 75 years old, as stipulated by the prerequisites."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~5 spots leftby Feb 2025