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

4 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if Blood Flow Restriction (BFR) training can help patients aged 14-30 with symptoms after a concussion exercise more effectively. BFR uses a cuff to limit blood flow, making light exercises feel more intense. This could help these patients gain the benefits of exercise without worsening their symptoms. Blood Flow Restriction (BFR) training has been used to increase strength and muscle mass in various populations, including those with chronic conditions like multiple sclerosis and Parkinson's disease.

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 data supports the effectiveness of the treatment Blood Flow Restriction Training with Exercise for Post-Concussion Syndrome?

Blood Flow Restriction Training (BFR) has shown benefits in improving muscle strength, size, and aerobic performance in various populations, including those with neurological disorders and musculoskeletal issues. While specific data for post-concussion syndrome is limited, these findings suggest potential benefits for improving physical function and rehabilitation outcomes. ^{1 2 3 4 5}

Is Blood Flow Restriction Training generally safe for humans?

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 were reported. This suggests that BFR training is generally safe for humans. ^{6 7 8 9 10}

How does Blood Flow Restriction Training with Exercise differ from other treatments for post-concussion syndrome?

Blood Flow Restriction Training (BFR) is unique because it involves performing low-intensity exercises while restricting blood flow to the muscles using a cuff, which can lead to strength gains and improved performance with less exertion compared to traditional high-intensity exercise. This approach is novel for post-concussion syndrome as it may offer rehabilitation benefits without the need for high physical stress, which is important for individuals recovering from concussions. ^{3 11 12 13 14}

Research Team

Laura Pietrosimone

Principal Investigator

Duke University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Blood Flow Restriction in Neurological Disorders: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Blood Flow Restriction Training on Blood Perfusion and Work Ability of Muscles in Elite Para-alpine Skiers. [2023]

4. Denmark pubmed.ncbi.nlm.nih.gov

Unilateral bicep curl hemodynamics: Low-pressure continuous vs high-pressure intermittent blood flow restriction. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Blood Flow Restriction Training on Aerobic Capacity and Performance: A Systematic Review. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise is Medicine for Concussion. [2019]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Use of Supervised Exercise During Recovery Following Sports-Related Concussion. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of Interval-Training Exercise on People Who Have Had Persistent Post-Concussive Symptoms for Less Than One Year: A Pilot Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. [2022]

11. United States 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. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Comparison of blood flow restriction devices and their effect on quadriceps muscle activation. [2021]

13. England pubmed.ncbi.nlm.nih.gov

The role of blood flow restriction training for applied practitioners: A questionnaire-based survey. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

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