Blood Flow Restriction Concussion

NCT03695042 | Terminated

• 1 other identifier: Pro00100185
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion Post Syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and 8 weeks

Secondary Outcomes (5)

• Change in Global Function Rating

  Baseline and 8 weeks

• Change in Heart Rate Variability

  1 week, 3 weeks, 6 weeks, 8 weeks

• Change in Presence of Orthostatic Tachycardia

  Baseline, 1 week, 2 weeks

• Change in Presence of Orthostatic Symptoms (Headache)

  Baseline, 1 week, 2 weeks

• Change in Presence of Orthostatic Symptoms (dizziness/light headedness)

  Baseline, 1 week, 2 weeks

Study Arms (2)

BFR THEN without BFR

EXPERIMENTAL

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

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

Other: Blood Flow Restriction Training with Exercise

Interventions

Blood Flow Restriction Training with Exercise OTHER

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

BFR THEN without BFR; Without BFR THEN with BFR

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Sports Science Institute

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Blood Flow Restriction Therapy; Exercise

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura Pietrosimone

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 3, 2018
• Study Start: January 15, 2019
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)