Blood-Flow Restriction Exercise for Knee Replacement

Overseen By Director, Human Research Protections

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michigan Technological University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Steven Elmer

Principal Investigator

Michigan Technological University

Eligibility Criteria

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.

Inclusion Criteria

I have never had a knee injury or surgery.

I had knee replacement surgery on one knee more than 6 months ago.

I am between 40 and 75 years old.

Exclusion Criteria

You smoke cigarettes.

Have any implanted devices such as but not limited to a pacemaker or pain pump

I have had a heart attack or stroke.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform blood-flow restriction exercise enhancement (B-FREE) at home 3 times per week for 10 weeks

10 weeks

Home-based program

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• B-FREE

Trial Overview 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.

Participant Groups

Group I: Adults with TKR Perform Home Exercise Program Experimental Treatment 1 Intervention

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

Group II: Healthy Controls Only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Michigan Technological University

Lead Sponsor

Trials

6

Recruited

700+

Blue Cross Blue Shield of Michigan Foundation

Collaborator

Trials

28

Recruited

51,200+