Early Sub-threshold Exercise Treatment for Concussion

NCT03569709 | Withdrawn DMC

• 1 other identifier: 1 R01 NS106260-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Each year millions of Americans suffer concussions as a result of accidents in sports, at work or through military service. Adolescents take the longest to recover from the effects of concussion yet no therapy exists to help speed their recovery. This project aims to see if a program of early guided aerobic exercise can safely speed recovery from concussion in adolescents and investigates some reasons for why this type of therapy could be effective.

Conditions

Concussion, Mild

Outcome Measures

Primary Outcomes (1)

• Time to recovery

  Time to baseline level of symptoms on Post Concussion Symptom Inventory (PCSI) for 2 days in a row

  up to 2 days

Secondary Outcomes (3)

• Autonomic function

  Within one week of injury and at 1 month after injury

• Delayed recovery

  1 and 4 months after concussion

• Cerebral Blood Flow (CBF)

  Within one week of injury and at 1 month after injury

Study Arms (3)

Aerobic Exercise

ACTIVE COMPARATOR

Sub-threshold aerobic exercise.

Behavioral: Aerobic Exercise

Stretching

PLACEBO COMPARATOR

Stretching program that will not raise heart rate.

Behavioral: Stretching

Rest

PLACEBO COMPARATOR

Relative rest. Avoid all structured exercise.

Behavioral: Rest

Interventions

Aerobic Exercise BEHAVIORAL

Progressive sub-threshold aerobic exercise

Aerobic Exercise

Rest BEHAVIORAL

No structured exercise.

Rest

Stretching BEHAVIORAL

Gentle progressive upper and lower extremity stretching program

Stretching

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years; any race, ethnicity, or sex.
• Concussion sustained 2-7 days prior to first clinical visit.
• Symptom score (new symptoms) \>3 on the Post-Concussion Symptom Inventory Scale.
• Glasgow Coma Scale (GCS) of 13-15 (if available in medical record), an alteration in mental status, loss of consciousness (if present) of less than 30 minutes, and post-traumatic amnesia (if present) limited to \<24 hours.
• Low risk for cardiac disease and willing to exercise.
• Medications, except for βeta- and calcium-blockers, are acceptable.

You may not qualify if:

• GCS score \<13 at time of injury.
• Lesion on CT/MRI (via review of emergency department records) and/or focal neurologic deficit consistent with an intracerebral lesion (e.g., unilateral weakness, dilated pupil).
• Inability to exercise because of orthopedic injury, significant vestibular dysfunction, visual abnormality, or increased cardiac risk.
• Neurosurgical intervention, general anesthesia and previously diagnosed neurological or psychiatric diseases.
• Additional head injury after study enrollment.
• Active substance abuse/dependence.
• Non-fluency in English.
• βeta- and calcium blocker use.
• Autism, metal braces or other metal that would interfere with ASL.
• Unwilling to exercise.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Children's Hospital of Philadelphia: collaborator
• Harvard University: collaborator
• The Mind Research Network: collaborator

MeSH Terms

Conditions

Brain Concussion

Interventions

Exercise; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 26, 2018
• Study Start: June 15, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share