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Blood Flow Restriction Concussion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695042
Recruitment Status : Suspended (Covid-19)
First Posted : October 3, 2018
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Concussion Post Syndrome Other: Blood Flow Restriction Training with Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Utilization of Blood Flow Restriction Training in Post Concussion Recovery
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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Arm Intervention/treatment
Experimental: BFR THEN without BFR
Will perform exercises with BFR at the first visit and without BFR at the second visit
Other: Blood Flow Restriction Training with Exercise
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

Experimental: Without BFR THEN with BFR
Will perform exercises without BFR at the first visit and with BFR at the second visit
Other: Blood Flow Restriction Training with Exercise
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in Global Function Rating [ Time Frame: Baseline and 8 weeks ]
    The subject will be asked to report his/her function rating on a scale of 0-100%

  2. Change in Heart Rate Variability [ Time Frame: 1 week, 3 weeks, 6 weeks, 8 weeks ]
    Heart Rate Variability will be compared, over time, to the baseline variability measured at the initial evaluation

  3. Change in Presence of Orthostatic Tachycardia [ Time Frame: Baseline, 1 week, 2 weeks ]
    Orthostatic Tachycardia will be recorded as either present or absent

  4. Change in Presence of Orthostatic Symptoms (Headache) [ Time Frame: Baseline, 1 week, 2 weeks ]
    Symptom of headache onset during a orthostatic position change will be recorded as present or not present

  5. Change in Presence of Orthostatic Symptoms (dizziness/light headedness) [ Time Frame: Baseline, 1 week, 2 weeks ]
    Symptom of dizziness/light headedness onset during a orthostatic position change will be recorded as present or absent



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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695042


Locations
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United States, North Carolina
Duke Sports Science Institute
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Laura Pietrosimone Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03695042    
Other Study ID Numbers: Pro00100185
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Post-Concussion Syndrome
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating