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

Primary Purpose

Brain Concussion, Pediatric, Mild Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sub symptom aerobic exercise
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Aged 10 - 18 years to ensure a pediatric sample of participants.
  3. A persistent postconcussion symptom risk score ≥ 9 to ensure all participants are in the high risk of persistent postconcussion symptom category.
  4. A Post-Concussion Symptom Inventory score > 9 to ensure participants have not recovered by the time they enroll in the study.
  5. Access to an internet connection (via computer or smart phone) so that physical activity and exercise can be tracked via heart rate monitor.

Exclusion Criteria:

  1. Concurrent lower extremity injury so that exercise testing results are not confounded by other injury.
  2. Aerobic exercise contraindication so that participants are able to complete the exercise testing protocol.
  3. 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.
  4. 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.

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Pediatric 25
A brief generalized quality of life questionnaire. We will calculate the sub-scale scores for the domains of Mobility, Depressive Symptoms, Anxiety, Peer Relationships, and Pain Interference. Each sub-scale is calculated as a sum of 4 questions, rated from 0-4. Thus, each subscale is from 0-16, where a 16 indicates a greater presence of the domain being measured.
Change from Baseline in Tampa Scale of Kinesiophobia
A brief questionnaire about fear of movement and injury related to returning to sport. The subject answers 18 questions rated from 1 (strongly disagree) to 4 (strongly agree). There is a total sum score ranging form 18-72, where a higher score represents more fear of movement.
Change from Baseline in Physical activity level
In order to assess the effect of physical activity level on recovery, we will provide participants with heart-rate activity monitors.
Change from Baseline in Dual-task walking speed
Measure of the the average walking speed of subjects during dual-task conditions (m/s).

Full Information

First Posted
December 10, 2019
Last Updated
May 2, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04199247
Brief Title
Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury
Official Title
Initiation of an Early Exercise Program to Improve Symptoms and Psychosocial Function After Pediatric Mild Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
November 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The long-term research goal of the proposed study is to develop individualized sub-symptom exercise prescriptions for youth who sustain mild traumatic brain injury that can help to alleviate mild traumatic brain injury symptoms, reduce the risk of persistent post-concussion symptoms, and improve psychosocial outcomes. The overall objectives of this application are to prospectively (1) determine if a prescribed exercise program initiated within the first week of mild traumatic brain injury can reduce the risk of developing persistent post-concussion symptoms and (2) examine the effects of an exercise program on psychosocial, sleep, and pain outcomes when initiated within 7 days of injury and continued for two months. The investigators will address these objectives by testing the central hypotheses that those assigned to an exercise intervention will have lower risk of developing persistent post-concussion symptoms and will report lower anxiety, depression, and pain interference ratings, higher peer relationship ratings, and better sleep quality ratings compared to usual care. In order to achieve this, the investigators will use a block stratified randomized intervention design. Block stratified randomization procedures will be conducted according to standard procedures so that sample numbers are equally assigned to each group, selected due to the relatively small sample size of the proposed study. Participants will be identified, enrolled, and assessed within 5 days of mild traumatic brain injury, randomized to an exercise intervention or usual care group 3-7 days after mild traumatic brain injury, and follow-up with in person assessments at approximately one and two months post-injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Pediatric, Mild Traumatic Brain Injury, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will continue with their return to play progression based upon the advice given to them at their initial post-injury evaluation.
Intervention Type
Behavioral
Intervention Name(s)
Sub symptom aerobic exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Post Concussion Symptom Inventory
Description
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.
Time Frame
Baseline (within 1 week of injury), Month 1, Month 2
Secondary Outcome Measure Information:
Title
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Pediatric 25
Description
A brief generalized quality of life questionnaire. We will calculate the sub-scale scores for the domains of Mobility, Depressive Symptoms, Anxiety, Peer Relationships, and Pain Interference. Each sub-scale is calculated as a sum of 4 questions, rated from 0-4. Thus, each subscale is from 0-16, where a 16 indicates a greater presence of the domain being measured.
Time Frame
Baseline (within 1 week of injury), Month 1, Month 2
Title
Change from Baseline in Tampa Scale of Kinesiophobia
Description
A brief questionnaire about fear of movement and injury related to returning to sport. The subject answers 18 questions rated from 1 (strongly disagree) to 4 (strongly agree). There is a total sum score ranging form 18-72, where a higher score represents more fear of movement.
Time Frame
Baseline (within 1 week of injury), Month 1, Month 2
Title
Change from Baseline in Physical activity level
Description
In order to assess the effect of physical activity level on recovery, we will provide participants with heart-rate activity monitors.
Time Frame
Baseline (within 1 week of injury), Month 1, Month 2
Title
Change from Baseline in Dual-task walking speed
Description
Measure of the the average walking speed of subjects during dual-task conditions (m/s).
Time Frame
Baseline (within 1 week of injury), Month 1, Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Howell, PhD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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