Blood Flow Restriction Training for Post-Concussion Syndrome

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Neurological deficits, Clot history, Cancer, others

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

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how blood flow restriction (BFR) training can assist individuals with post-concussion syndrome who struggle with physical activity. BFR training uses a special technique to enhance exercise results by restricting blood flow during low-impact exercise, simulating the effects of high-impact training. Researchers aim to reduce concussion symptoms and support a return to normal activities. The trial targets individuals aged 14 to 30 who have experienced concussion symptoms for over four weeks and find that exercise exacerbates their symptoms. Participants will perform exercises with and without BFR to determine the most effective approach. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for post-concussion syndrome.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that blood flow restriction training is safe for post-concussion syndrome patients?

Research has shown that blood flow restriction (BFR) training with exercise is safe for people with post-concussion symptoms. One study found that participants using this method did not experience any negative effects, indicating that BFR training is generally well-tolerated. Additionally, Duke Sports Physical Therapy uses BFR with various patients without issues. Therefore, for those considering joining a trial involving BFR training, current evidence suggests it is a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Blood Flow Restriction (BFR) Training for Post-Concussion Syndrome because it offers a novel approach to rehabilitation. Traditional treatments for post-concussion syndrome often include rest, cognitive therapy, and medication. However, BFR with exercise is different because it involves light exercise while restricting blood flow, which may enhance muscle strength and recovery without the need for intense workouts. This method could potentially accelerate healing and improve outcomes by promoting better circulation and reducing the risk of overexertion. By potentially speeding up recovery, BFR Training could offer a significant advancement in managing post-concussion symptoms.

What evidence suggests that blood flow restriction training is effective for post-concussion syndrome?

Research has shown that blood flow restriction (BFR) training can help individuals with post-concussion syndrome by reducing symptoms and improving brain function. In this trial, participants will experience both approaches: one group will perform exercises with BFR at the first visit and without BFR at the second visit, while the other group will do the reverse. Studies have found that BFR training combined with exercise is safe for those with post-concussion symptoms, with no negative side effects reported. It has enhanced sensorimotor function, which is how well the brain and body work together for movement. Participants using BFR training recovered better than those who exercised without it. Additionally, BFR therapy has increased muscle strength and reduced pain and swelling in other conditions, suggesting it might be beneficial here too. Overall, BFR training appears promising for aiding recovery after a concussion. ^{1 2 3 4 6}

Who Is on the Research Team?

Laura Pietrosimone

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 14-30 with Post-Concussion Syndrome, experiencing symptoms over four weeks and worsened by physical activity. It's not suitable for those with open wounds, clot history, circulation issues, sickle cell anemia, infections near the tourniquet area, cancer or lymph removal.

Inclusion Criteria

I have been diagnosed with Post-Concussion Syndrome.

I am between 14 and 30 years old.

Ability to read, write, and speak the English language

Exclusion Criteria

I do not have open wounds, clots, poor circulation, sickle cell, infections near the tourniquet area, cancer, or have had a lymphectomy.

I have a history of migraines.

I have specific areas of weakness or loss of function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Initial Evaluation

Participants undergo a physical therapy concussion evaluation including orthostatic measurements, cervical screen, and vestibular-oculomotor screen. Initial questionnaires and heart rate variability are assessed.

1 week

1 visit (in-person)

Treatment

Participants perform exercises with and without blood flow restriction (BFR) to assess exercise tolerance and symptom provocation.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in post-concussion symptoms, global function rating, and heart rate variability.

8 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction Training with Exercise

Trial Overview

The study tests if blood flow restriction training combined with low load exercise can help concussion patients who struggle with regular exercises. The goal is to see if this method can produce benefits similar to high load training without worsening concussive symptoms.

How Is the Trial Designed?

Group I: Without BFR THEN with BFR Experimental Treatment 1 Intervention

Will perform exercises without BFR at the first visit and with BFR at the second visit

Group II: BFR THEN without BFR Experimental Treatment 1 Intervention

Will perform exercises with BFR at the first visit and without BFR at the second visit

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Blood flow restriction training (BFRT) can be beneficial for rehabilitation but poses risks such as increased blood pressure and adverse cardiovascular responses, especially in individuals with pre-existing conditions like hypertension and diabetes.

To ensure safety, a risk stratification tool is recommended for clinicians to assess patients' medical histories and identify those who may be at higher risk for complications when undergoing BFRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. Nascimento, DDC., Rolnick, N., Neto, IVS., et al.[2022]

A study of 126 patients with acute sport-related concussions showed that supervised exercise (SE) initiated within 16 days of injury was safe, with no serious adverse events reported.

Early SE was linked to a significantly quicker return to sport, with patients returning in an average of 26.5 days compared to 35.1 days for those who did not undergo early SE, suggesting it may help speed up recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Supervised Exercise During Recovery Following Sports-Related Concussion. Popovich, M., Almeida, A., Freeman, J., et al.[2021]

A study involving 12 patients with post-concussion syndrome showed that subsymptom threshold exercise training is safe and leads to significant improvements in exercise capacity and reduction of PCS symptoms over 2 to 3 weeks.

Participants were able to exercise longer and at higher heart rates without exacerbating symptoms, with athletes recovering faster than nonathletes, indicating that controlled exercise can be an effective treatment for PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Leddy, JJ., Kozlowski, K., Donnelly, JP., et al.[2022]

In a study of 39 female patients with chronic ankle instability, Blood Flow Restriction (BFR) training alone did not improve muscle strength, dynamic balance, or physical function, while combined BFR with rehabilitation and rehabilitation alone showed significant improvements.

Both the BFR+R and R groups demonstrated enhanced muscle strength and dynamic balance, indicating that BFR is more effective when used alongside rehabilitation rather than as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of blood flow restriction as a stand-alone treatment on muscle strength, dynamic balance, and physical function in female patients with chronic ankle instability. Mahmoud, WS., Radwan, NL., Ibrahim, MM., et al.[2023]

High-load resistance exercise (HL) resulted in significantly greater quadriceps muscle activation compared to low-load blood flow restriction training (BFRT) using both regulated and standardized devices, indicating that traditional strength training may be more effective for muscle activation.

Participants reported higher pain and perceived exertion during the regulated BFRT sessions compared to the standardized BFRT and high-load resistance exercise, suggesting that while BFRT can be effective, it may also be associated with greater discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of blood flow restriction devices and their effect on quadriceps muscle activation. Bordessa, JM., Hearn, MC., Reinfeldt, AE., et al.[2021]

The Montreal Virtual Exertion (MOVE) protocol is a safe and feasible graded exertion test for both healthy children and those with subacute concussion, as no adverse events were reported during the study.

Increases in heart rate and perceived exertion were similar between the MOVE protocol and the traditional Buffalo Concussion Treadmill Test, suggesting that MOVE can effectively assess exertion levels without the need for expensive equipment or in-person supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. Teel, E., Alarie, C., Swaine, B., et al.[2023]

Blood flow restriction training, which involves low-intensity exercise while wearing a blood pressure cuff, is proposed to enhance strength gains and improve performance, despite skepticism from physical therapists about its effectiveness.

This training method may also lead to shorter recovery times and reduced pain after exercise, suggesting potential benefits for rehabilitation and performance enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training in Rehabilitation: A Useful Adjunct or Lucy's Latest Trick? Whiteley, R.[2020]

Citations

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ijfmr.com

ijfmr.com/research-paper.php?id=55636

Blood Flow Restriction Training for Post-Concussion ...

Results showed that athletes in the BFR group reported a greater reduction in PCS symptoms, demonstrated improved cognitive performance, and ...

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withpower.com

withpower.com/trial/phase-post-concussion-syndrome-2019-4b1af

Blood Flow Restriction Training for Post-Concussion ...

A study involving Blood Flow Restriction (BFR) training with exercise showed that it was safe for people with post-concussive symptoms, as no adverse events ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9778162/

Effectiveness of Blood Flow Restriction in Neurological ...

Improvements have been found in sensorimotor function, frequency and step length symmetry, perceived exertion, heart rate and gait speed, walking endurance, ...

4.

journals.sagepub.com

journals.sagepub.com/doi/full/10.1089/neu.2019.6915

Effects of Interval-Training Exercise on People Who Have ...

More stable recovery was found in individuals who exercised using BFR and BC than in those who underwent exercise without BFR and BC. Moderate intensity- ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/07853890.2023.2240329

The effectiveness and safety of blood flow restriction ...

BFR therapy effectively relieved pain and swelling, increased muscle strength and wrist function, and had no additional risks for bone healing and VT.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8963452/

A Useful Blood Flow Restriction Training Risk Stratification for ...

Satoh (2011) showed beneficial effects of BFRT on 51 cases with metabolic syndrome, as evidenced in a 10% drop in systolic blood pressure (SBP) and diastolic ...