Concussion Post SyndromeNCT03695042
Blood Flow Restriction Concussion
A study testing Blood Flow Restriction Training with Exercise in people with Concussion Post Syndrome, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Concussion Post Syndrome
- What is being tested?
- Blood Flow Restriction Training with Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Sports Science Institute
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Concussion Post Syndrome
- Being tested
- Blood Flow Restriction Training with Exercise
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Training with ExerciseOther
The addition of BFR training to an exercise program prescribed for a patient participating in physical therapy for concussion treatment. BFR training partially occludes blood flow to extremities during exercise. This allows one to exercise at lower loads and still gain benefits similar to exercise at higher loads
| Study group | Role | What they receive |
|---|---|---|
| BFR THEN without BFR | Experimental | Will perform exercises with BFR at the first visit and without BFR at the second visit Receives: Other: Blood Flow Restriction Training with Exercise |
| Without BFR THEN with BFR | Experimental | Will perform exercises without BFR at the first visit and with BFR at the second visit Receives: Other: Blood Flow Restriction Training with Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post Concussion Symptom Score
The Post Concussion Symptoms Score is a self-reported measurement of symptoms associated with concussion with items ranked from 0 (no symptoms) to 6 (severe symptoms)
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Change in Global Function Rating
The subject will be asked to report his/her function rating on a scale of 0-100%
Measured: Baseline and 8 weeks
Change in Heart Rate Variability
Heart Rate Variability will be compared, over time, to the baseline variability measured at the initial evaluation
Measured: 1 week, 3 weeks, 6 weeks, 8 weeks
Change in Presence of Orthostatic Tachycardia
Orthostatic Tachycardia will be recorded as either present or absent
Measured: Baseline, 1 week, 2 weeks
Change in Presence of Orthostatic Symptoms (Headache)
Symptom of headache onset during a orthostatic position change will be recorded as present or not present
Measured: Baseline, 1 week, 2 weeks
Change in Presence of Orthostatic Symptoms (dizziness/light headedness)
Symptom of dizziness/light headedness onset during a orthostatic position change will be recorded as present or absent
Measured: Baseline, 1 week, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start15 Jan 2019
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Why it stopped: Difficulty enrolling target population within target timeframe
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion Post SyndromeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Pietrosimone, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695042
- Sponsor's protocol ID
- Pro00100185
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2018
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Blood Flow Restriction Training in Post Concussion Recovery
- ClinicalTrials.gov ID
- NCT03695042
- Acronym / sponsor ID
- Pro00100185
- Conditions
- Concussion Post Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling target population within target timeframe
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR THEN without BFR | Experimental | Other: Blood Flow Restriction Training with ExerciseWill perform exercises with BFR at the first visit and without BFR at the second visit |
| Without BFR THEN with BFR | Experimental | Other: Blood Flow Restriction Training with ExerciseWill perform exercises without BFR at the first visit and with BFR at the second visit |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction Training with ExerciseThe addition of BFR training to an exercise program prescribed for a patient participating in physical therapy for concussion treatment. BFR training partially occludes blood flow to extremities during exercise. This allows one to exercise at lower loads and still gain benefits similar to exercise at higher loads | Other | BFR THEN without BFR, Without BFR THEN with BFR |
Primary outcome
Change in Post Concussion Symptom Score
Time frame: Baseline and 8 weeks
The Post Concussion Symptoms Score is a self-reported measurement of symptoms associated with concussion with items ranked from 0 (no symptoms) to 6 (severe symptoms)
5 secondary outcomes
Change in Global Function Rating
Time frame: Baseline and 8 weeks
Change in Heart Rate Variability
Time frame: 1 week, 3 weeks, 6 weeks, 8 weeks
Change in Presence of Orthostatic Tachycardia
Time frame: Baseline, 1 week, 2 weeks
Change in Presence of Orthostatic Symptoms (Headache)
Time frame: Baseline, 1 week, 2 weeks
Change in Presence of Orthostatic Symptoms (dizziness/light headedness)
Time frame: Baseline, 1 week, 2 weeks
Results and safety
The study was stopped early (reason given: Difficulty enrolling target population within target timeframe). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Concussion Post Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Pietrosimone principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training with Exercise in people with Concussion Post Syndrome, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty enrolling target population within target timeframe). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post Concussion Symptom Score (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.