Blood Flow Restriction Concussion
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 14 - 30 |
| Updated: | 2/3/2019 |
| Start Date: | January 15, 2019 |
| End Date: | December 2019 |
The Utilization of Blood Flow Restriction Training in Post Concussion Recovery
The purpose of this study is to examine the effect that blood flow restriction training will
have on patients with concussion who demonstrate an intolerance to physical activity.
Progressive exercise training has been shown to effectively reduce the effects of concussion
and facilitate return to academic and athletic activities. In many cases, exercises
intolerance is present in these patients which hinders progression. In musculoskeletal
conditions, blood flow restriction training, when combined with low load exercise, has been
shown to produce similar gains as high load exercises. If a patient being treated for
concussion can tolerate low load exercise without concussive symptoms, then blood flow
restriction may increase exercise gains by facilitating autonomic responses similar to high
load training. This study will explore this hypothesis in patients between the ages of 14 and
30 who are referred for physical therapy intervention which is the standard of care at Duke
Sports Sciences Concussion Clinic. Blood flow restriction training is also used in multiple
patient populations at Duke Sports Physical Therapy without adverse events.
have on patients with concussion who demonstrate an intolerance to physical activity.
Progressive exercise training has been shown to effectively reduce the effects of concussion
and facilitate return to academic and athletic activities. In many cases, exercises
intolerance is present in these patients which hinders progression. In musculoskeletal
conditions, blood flow restriction training, when combined with low load exercise, has been
shown to produce similar gains as high load exercises. If a patient being treated for
concussion can tolerate low load exercise without concussive symptoms, then blood flow
restriction may increase exercise gains by facilitating autonomic responses similar to high
load training. This study will explore this hypothesis in patients between the ages of 14 and
30 who are referred for physical therapy intervention which is the standard of care at Duke
Sports Sciences Concussion Clinic. Blood flow restriction training is also used in multiple
patient populations at Duke Sports Physical Therapy without adverse events.
This is a prospective randomized proof of concept trial comparing the efficacy of the novel
application of blood flow restriction to improve exercise tolerance in patients with
post-concussion syndrome. Blood flow restriction training is commonly used in combination
with low intensity/load exercise to facilitate exercise tolerance in those that would not
tolerate high intensity/load exercises. While this intervention has been clinically employed
in patients with concussion, research is needed to establish it's efficacy in a meaningful
and prospective way. Subjects in this study will be randomly assigned to one of two groups.
One group will perform exercises with BFR and then without BFR. The other group will perform
the exercises without BFR first and then perform them with BFR. Each subject will undergo a
single physical therapy session in each condition. Subjects meeting study criteria will be
randomly allocated to each group. Because concussion symptoms can change quickly over time,
it will be important to vary the timing of when the blood flow restriction is performed to
better understand if improvement is due to intervention or passage of time. Randomization
will be performed via sealed envelope to ensure even distribution into both groups.
Patients presenting to physical therapy for treatment of concussion symptoms will undergo a
physical therapy concussion evaluation that includes orthostatic measurements, cervical
screen, and vestibular-oculomotor screen. Patients will report a Global Function Rating and
complete a Post-concussion Symptom Score, Neck Disability Index, and Dizziness Handicap
Inventory at initial visit. Heart rate variability will also be assessed at initial visit.
The measurements and questionnaires collected at the initial evaluation are part of the
standard of care at this clinic. Subjects will be recruited after the initial visit and will
have already completed these measurements/questionnaires. It is also standard of care to
continue to administer these questionnaires as symptom status changes throughout the course
of treatment until discharge. At the subsequent visit, subjects will undergo cardiovascular
testing on a stationary bike to identify symptom provocation and exercise tolerance with
aerobic exercise. The above evaluative tools and interventions are standard of practice for
concussion patients being treated by physical therapy at the Duke Sports Concussion Clinic.
Intervention Procedure (BFR):
A blood flow restriction (BFR) cuff is applied to dominant leg and limb occlusion pressure
(LOP) and personalized tourniquet pressure (PTP) at 80% is determined with the patient in
supine.
Using an established BFR protocol of 4 sets of exercises with repetitions of 30-15-15-15, the
patient will perform the exercises of double leg squat and forward lunge under occlusion.
There will be a 30 second break between each set and 1 minute break between exercises.
Then, the physical therapist will move BFR cuff to opposite leg and reassess LOP/PTP 80%. The
patient will repeat squat and forward lunge exercises as above.
The treatment will be discontinued if there is a greater than 3 point change in subjective
symptom report. If the patient reports leg pain/discomfort, the pressure will be decreased by
10%. If still unable to complete the exercise due to leg discomfort, the intervention will be
discontinued.
The following will be recorded:
Heart rate range during each set Maximum heart rate during the recovery period Rate of
Perceived Exertion (RPE) and symptom report will be obtained during each recovery period.
Total time under occlusion upon completion of the round.
Intervention Procedure (No BFR):
Subjects will perform the 4 sets of each exercise with repetitions of 30-15-15-15. There will
be a 30 second break between each set and 1 minute break between exercises.
The exercises will include double leg squat, dominant leg forward lunge, repeat double leg
squat, and non-dominant leg forward lunge
The following will be recorded:
Heart rate range during each set Maximum heart rate during the recovery period Rate of
Perceived Exertion (RPE) and symptom report will be obtained during each recovery period.
application of blood flow restriction to improve exercise tolerance in patients with
post-concussion syndrome. Blood flow restriction training is commonly used in combination
with low intensity/load exercise to facilitate exercise tolerance in those that would not
tolerate high intensity/load exercises. While this intervention has been clinically employed
in patients with concussion, research is needed to establish it's efficacy in a meaningful
and prospective way. Subjects in this study will be randomly assigned to one of two groups.
One group will perform exercises with BFR and then without BFR. The other group will perform
the exercises without BFR first and then perform them with BFR. Each subject will undergo a
single physical therapy session in each condition. Subjects meeting study criteria will be
randomly allocated to each group. Because concussion symptoms can change quickly over time,
it will be important to vary the timing of when the blood flow restriction is performed to
better understand if improvement is due to intervention or passage of time. Randomization
will be performed via sealed envelope to ensure even distribution into both groups.
Patients presenting to physical therapy for treatment of concussion symptoms will undergo a
physical therapy concussion evaluation that includes orthostatic measurements, cervical
screen, and vestibular-oculomotor screen. Patients will report a Global Function Rating and
complete a Post-concussion Symptom Score, Neck Disability Index, and Dizziness Handicap
Inventory at initial visit. Heart rate variability will also be assessed at initial visit.
The measurements and questionnaires collected at the initial evaluation are part of the
standard of care at this clinic. Subjects will be recruited after the initial visit and will
have already completed these measurements/questionnaires. It is also standard of care to
continue to administer these questionnaires as symptom status changes throughout the course
of treatment until discharge. At the subsequent visit, subjects will undergo cardiovascular
testing on a stationary bike to identify symptom provocation and exercise tolerance with
aerobic exercise. The above evaluative tools and interventions are standard of practice for
concussion patients being treated by physical therapy at the Duke Sports Concussion Clinic.
Intervention Procedure (BFR):
A blood flow restriction (BFR) cuff is applied to dominant leg and limb occlusion pressure
(LOP) and personalized tourniquet pressure (PTP) at 80% is determined with the patient in
supine.
Using an established BFR protocol of 4 sets of exercises with repetitions of 30-15-15-15, the
patient will perform the exercises of double leg squat and forward lunge under occlusion.
There will be a 30 second break between each set and 1 minute break between exercises.
Then, the physical therapist will move BFR cuff to opposite leg and reassess LOP/PTP 80%. The
patient will repeat squat and forward lunge exercises as above.
The treatment will be discontinued if there is a greater than 3 point change in subjective
symptom report. If the patient reports leg pain/discomfort, the pressure will be decreased by
10%. If still unable to complete the exercise due to leg discomfort, the intervention will be
discontinued.
The following will be recorded:
Heart rate range during each set Maximum heart rate during the recovery period Rate of
Perceived Exertion (RPE) and symptom report will be obtained during each recovery period.
Total time under occlusion upon completion of the round.
Intervention Procedure (No BFR):
Subjects will perform the 4 sets of each exercise with repetitions of 30-15-15-15. There will
be a 30 second break between each set and 1 minute break between exercises.
The exercises will include double leg squat, dominant leg forward lunge, repeat double leg
squat, and non-dominant leg forward lunge
The following will be recorded:
Heart rate range during each set Maximum heart rate during the recovery period Rate of
Perceived Exertion (RPE) and symptom report will be obtained during each recovery period.
Inclusion Criteria:
Ability to read, write, and speak the English language Diagnosis of Post-Concussion
Syndrome (medical diagnosis of concussion with symptoms lasting greater than four weeks.
Increased symptoms with physical activity Ages 14-30 years old
Exclusion Criteria:
Focal neurological deficits Exclusion criteria for Blood Flow Restriction (open wounds or
fracture, history of clot, impaired circulation or venous compromise, sickle cell anemia,
extremity infection, tumor distal to tourniquet placement, cancer, lymphectomy) Migraine
history Positive image findings on MRI Benign Positional Paroxysmal Vertigo
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