Blood-Flow Restriction Exercise for Knee Replacement

Overseen By Director, Human Research Protections

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michigan Technological University

Disqualifiers: Smoking, Diabetes, Heart attack, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new exercise method called blood-flow restriction exercise enhancement (B-FREE) to address muscle weakness in the thigh, often occurring after knee replacement surgery. The goal is to determine if B-FREE can safely and effectively improve strength in the quadriceps muscle, crucial for walking and daily activities. The trial includes participants who had knee replacement surgery over six months ago and experience ongoing weakness, as well as healthy individuals without past knee issues. This study does not include smokers or those with conditions like diabetes or high blood pressure. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance recovery after knee replacement.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have controlled hypertension, it seems you can continue your medication.

What prior data suggests that blood-flow restriction exercise enhancement (B-FREE) is safe for overcoming quadriceps muscle weakness after knee replacement?

Research shows that blood-flow restriction exercise (B-FREE) is generally safe. Studies have found that this exercise can improve muscle strength and recovery. In one study, participants who used blood flow restriction with light exercises reported no major side effects. Another review examined its safety after knee surgeries and found it well-tolerated, particularly for enhancing muscle function.

Overall, B-FREE appears to be a promising method with a good safety record. While no treatment is entirely risk-free, evidence suggests it is safe for those recovering from knee replacements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Blood-Flow Restriction Exercise (B-FREE) for knee replacement recovery because it offers a fresh approach to rehabilitation. Unlike traditional exercises that require heavy weights to build muscle strength, B-FREE allows patients to achieve similar benefits with lighter loads by restricting blood flow. This method potentially reduces the risk of injury and makes it easier for patients to perform exercises at home, enhancing their recovery experience. By making post-surgery exercises more accessible and less intimidating, B-FREE could improve overall outcomes for those recovering from total knee replacements.

What evidence suggests that B-FREE is effective for overcoming quadriceps muscle weakness after knee replacement?

Research has shown that blood-flow restriction exercise (B-FREE) can build muscle strength and size without heavy weights. Studies have found this exercise effective in boosting muscle strength and function after knee surgery. In this trial, participants with a total knee replacement will perform a home-based exercise program incorporating B-FREE to overcome muscle weakness following surgery. Reviews also emphasize the safety and success of B-FREE in aiding recovery. These findings suggest that B-FREE could be a promising way to improve muscle strength after knee surgery. ^{2 3 5 6 7}

Who Is on the Research Team?

Steven Elmer

Principal Investigator

Michigan Technological University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33004382/

protocol for a multicentre randomised controlled trial We intend to examine if low-load blood flow restricted exercise (BFRE) is an effective preoperative method to increase functional capacity, lower limb muscle ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1360859225000154

Exercise with blood flow restriction among adults ... Rehabilitation with blood flow restriction (BFR) produces gains in strength and muscle mass, avoiding the use of heavy loads.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04081493

The Efficacy of Low-load Blood Flow Restricted Resistance ... The primary aim of this study is to investigate the efficacy of 8 weeks of Low-load blood flow restricted exercise (BFRE) compared to receiving standard care ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09071-7

Preoperative blood flow restriction training combined with ... This study is designed to evaluate the effectiveness of integrating short-term preoperative blood flow restriction (BFR) training with ...

5. mdpi.com mdpi.com/1648-9144/61/10/1879

Blood Flow Restriction Training in Knee Arthroplasty This review aimed to systematically evaluate the effectiveness and safety of BFR training in improving muscle strength and functional outcomes following knee ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10199744/

Knee Loading With Blood Flow Restriction Can Enhance ... Evidence indicates that blood flow restriction (BFR) training has significant potential to enhance recovery via implementation of low-load or low-intensity ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6203234/

Blood Flow Restriction Therapy After Knee Surgery Clark B.C., Manini T.M., Hoffman R.L. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults.