Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury

NCT04199247 | Completed

• 1 other identifier: 17-2020
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the central hypotheses according to the following Specific Aims: Aim 1. Determine if an individually prescribed exercise program initiated within the first week of mild traumatic brain injury can reduce the risk of developing persistent post-concussion symptoms relative to usual care. The investigators hypothesize that the exercise group will have a lower risk of developing persistent post-concussion symptoms than the usual care group. Aim 2. Examine the effect of a two-month exercise program on psycho-social, pain interference, and sleep outcomes following mild traumatic brain injury. The investigators hypothesize the exercise group will report lower anxiety, depression, and pain interference ratings, and higher peer relationship and sleep quality ratings two months of exercise following mild traumatic brain injury compared to usual care.

Conditions

Brain Concussion; Pediatric; Mild Traumatic Brain Injury; Psychological

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Post Concussion Symptom Inventory

  Overall symptom severity, rated as a sum score from 0-122. A higher score indicates more severe symptoms, while a 0 indicates that the patient is not experiencing symptoms.

  Baseline (within 1 week of injury), Month 1, Month 2

Secondary Outcomes (4)

• Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Pediatric 25

  Baseline (within 1 week of injury), Month 1, Month 2

• Change from Baseline in Tampa Scale of Kinesiophobia

  Baseline (within 1 week of injury), Month 1, Month 2

• Change from Baseline in Physical activity level

  Baseline (within 1 week of injury), Month 1, Month 2

• Change from Baseline in Dual-task walking speed

  Baseline (within 1 week of injury), Month 1, Month 2

Study Arms (2)

Exercise

EXPERIMENTAL

Within 1 week of injury, participants will be randomized to either a sub symptom threshold exercise program (intervention group) or usual care (recommendation from their doctor). Those in the intervention group will participate in an exercise program 5x/week, 20-30 minutes/session, for 2 months.

Behavioral: Sub symptom aerobic exercise

Usual Care

NO INTERVENTION

Participants will continue with their return to play progression based upon the advice given to them at their initial post-injury evaluation.

Interventions

Sub symptom aerobic exercise BEHAVIORAL

Participants will meet with a member of the research team to undergo a bike-based exercise test at the initial test. Heart rate will be obtained at the completion of the test, and intervention participants will be asked to complete exercise at 80% of that level, 5x/week for 20-30 minutes/session over the next two months.

Exercise

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Concussion or mTBI diagnosis by a board-certified Sports Medicine physician, pediatric Emergency Medicine physician, general pediatrician physician, or advanced practice provider under the direction of a physician. This will be defined in a similar manner according to available guidelines: a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment
• Aged 10 - 18 years to ensure a pediatric sample of participants.
• A persistent postconcussion symptom risk score ≥ 9 to ensure all participants are in the high risk of persistent postconcussion symptom category.
• A Post-Concussion Symptom Inventory score \> 9 to ensure participants have not recovered by the time they enroll in the study.
• Access to an internet connection (via computer or smart phone) so that physical activity and exercise can be tracked via heart rate monitor.

You may not qualify if:

• Concurrent lower extremity injury so that exercise testing results are not confounded by other injury.
• Aerobic exercise contraindication so that participants are able to complete the exercise testing protocol.
• Diagnosed mild traumatic brain injury by a healthcare provider within 6 months of qualifying injury to ensure that residual effects of prior mild traumatic brain injury do not bias the results of our investigation.
• Mild traumatic brain injury that results in positive findings on neuroimaging, or extra-axial or intraparenchymal bleeds to avoid potential injuries that are more severe than mild traumatic brain injury.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Brain Concussion

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

Study Officials

• David R Howell, PhD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Within 1 week of injury, participants will be randomized to either a sub symptom threshold exercise program (intervention group) or usual care (recommendation from their doctor). Those in the intervention group will participate in an exercise program 5x/week, 20-30 minutes/session, for 2 months.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: February 20, 2020
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)