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Exercise for Adolescents Following Sport-Related Concussion: A Randomized Control Trial

Primary Purpose

Sport-related Concussion, Concussion, Mild Traumatic Brain Injury (MTBI)

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active Rehabilitation Program
Treatment-as-usual (TAU)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sport-related Concussion focused on measuring active rehabilitation, exercise, concussion

Eligibility Criteria

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

Adolescents referred to G. F. Strong Rehabilitation Centre (GFS) for atypical recovery preventing them from entering standard return to activities protocols will be recruited on a voluntary basis to participate in this study.

Eligibility criteria for study entry are as follows:

  1. sustained an injury in sports,
  2. are 4 weeks post injury,
  3. report 2+ persistent post-concussion symptoms with no significant improvement over the past week,
  4. are between the ages of 14 and 18,
  5. have no developmental, congenital, or cognitive diagnoses,
  6. have no active mental health disorders,
  7. are able to attend at GFS,
  8. speak English as their dominant language,
  9. have no prior moderate or severe TBI,
  10. have no concussion in the 6 months before the present injury, and
  11. medical clearance by the study physician.

Sites / Locations

  • GF Strong Rehabilitation CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment-as-usual (TAU)

Behavioral:Active Rehabilitation Program

Arm Description

The TAU program will be implemented after the initial assessment. It will consist of 2 components: An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms A school consultation to provide teacher education, recommend accommodations, and facilitate return to school

The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below: Sub-maximal aerobic training for up to 15 minutes Light coordination and sport-specific exercises for up to 10 minutes Visualization and imagery techniques Home program. A physiotherapist will supervise the rehabilitation.

Outcomes

Primary Outcome Measures

Symptom Report
The Post-Concussion Scale consists of 22 subjectively-experienced symptoms (e.g., headache, dizziness, concentration problems, and fogginess). A total score is derived from this 22-item scale. Athletes report symptoms based on the severity of each symptom that day, allowing tracking of symptoms over very short intervals
Symptom Report

Secondary Outcome Measures

Mood
The Beck Depression Inventory for Youth-Second Edition is a 20-item depression screening test designed for children and adolescents.
Energy level
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used to monitor fatigue in the study participants, another commonly reported complaint after a MTBI. The PedsQL was designed to measure fatigue in pediatric patients; it includes a General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items).
Balance Testing
The Balance Error Scoring System (BESS) is a commonly used measure of static balance and postural stability. The test is rapid, relatively easy-to-administer, and inexpensive. A combination of three stances (narrow double leg stance; single leg stance; and tandem stance) and footing surfaces (firm surface/floor or medium density foam) are used for the test. Each stance is held, with hands on hips and eyes closed, for 20 seconds. "Error" points are given for specific behaviors, including opening eyes, lifting hands off hips, or stepping, stumbling, or falling. Safety Issue: Falls and fall-related injuries. Testing will be supervised by a registered physiotherapist.
Neurocognitive Testing
ImPACT is a computerized neuropsychological test battery that consists of six individual test modules that measure multiple aspects of cognitive functioning including attention, memory, working memory, visual scanning, reaction time, and processing speed. The test takes 20-25 minutes. Four composite (i.e., summary) scores are tabulated based upon these individual test scores: Verbal Memory, Visual Memory, Reaction Time, and Processing Speed.
Return to School and Sport
Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals.
Mood
The Beck Depression Inventory for Youth-Second Edition will be used
Energy level
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used
Balance Testing
The Balance Error Scoring System (BESS) will be used
Neurocognitive Testing
ImPACT will be used.
Return to School and Sport
Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals.

Full Information

First Posted
December 10, 2013
Last Updated
April 7, 2015
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02031068
Brief Title
Exercise for Adolescents Following Sport-Related Concussion: A Randomized Control Trial
Official Title
Active Rehabilitation for Slow to Recover Adolescents Following Sport-Related Concussion: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

5. Study Description

Brief Summary
To test the safety and feasibility of a new treatment for adolescents who are slow to recover from a sport-related concussion, the investigators are conducting a randomised controlled trial comparing treatment as usual with an active rehabilitation program that involves sub-symptom threshold cardiac exertion, sport-specific coordination activities, and positive visualisation techniques.
Detailed Description
Most adolescents recover within the first month following a sport-related concussion. However, some do not. Little is known about how to best facilitate recovery when symptoms do not resolve spontaneously and swiftly. Although active rehabilitation has been recently suggested as a promising means of promoting recovery, current literature does not provide adequate evidence for safe adaptation into clinical practice. Objective: The purpose of this project is to evaluate an active rehabilitation protocol for adolescents who are slow to recover following sport-related concussion. Primary aims: to confirm the tolerability and safety of the active rehabilitation protocol as compared to treatment as usual controls. Secondary aims: 1) to document the impact of active rehabilitation on post-concussion symptoms and return to activity; 2) to explore the intervention effects on quality of life, mood, energy level, balance, cognitive functioning, and return to pre-injury activities. Study design: A parallel group open label randomized comparison trial of 30 adolescents who are slow to recover following sport-related concussion. After initial screening and assessment, both groups will receive treatment as usual. Participants in the experimental group will also participate in sub-symptom threshold exercise, sport-specific coordination practice, and positive visualisation daily. Outcome measures: The investigators will monitor for adverse events and assess post-concussion symptoms throughout the study as a primary marker of recovery. The investigators will also report secondary outcomes such as quality of life, mood, energy level, balance and cognitive functioning. Finally the investigators will record rates of return to school (full time, part time) and rates of return to sport (regular pre-injury vs. modified level). As a result, clinicians will be able to follow a new rehabilitation protocol in a safe and meaningful way. Lastly, research findings will be disseminated in the form of a publication, at conferences, and via in-services. Hypotheses: 1a. The drop-out rate will be comparable in the groups receiving treatment-as-usual (TAU) only versus TAU plus active rehabilitation. 1b. Adverse events occurring outside of the clinic will be comparable in the groups receiving TAU only versus TAU plus active rehabilitation. 1c. For the group receiving active rehabilitation, symptom exacerbations in the in-clinic exercise sessions will resolve within 30 minutes. 2. Participants receiving active rehabilitation will report greater improvement of post-concussion symptoms (primary outcome) at follow-up. 3. Participants receiving active rehabilitation will report higher quality of life, fewer depressive symptoms, and higher energy levels; demonstrate better balance and neuropsychological performance at follow-up; and return to their pre-injury activities at higher rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sport-related Concussion, Concussion, Mild Traumatic Brain Injury (MTBI)
Keywords
active rehabilitation, exercise, concussion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment-as-usual (TAU)
Arm Type
Active Comparator
Arm Description
The TAU program will be implemented after the initial assessment. It will consist of 2 components: An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms A school consultation to provide teacher education, recommend accommodations, and facilitate return to school
Arm Title
Behavioral:Active Rehabilitation Program
Arm Type
Experimental
Arm Description
The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below: Sub-maximal aerobic training for up to 15 minutes Light coordination and sport-specific exercises for up to 10 minutes Visualization and imagery techniques Home program. A physiotherapist will supervise the rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Active Rehabilitation Program
Intervention Description
The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below: Sub-maximal aerobic training for up to 15 minutes Light coordination and sport-specific exercises for up to 10 minutes Visualization and imagery techniques Home program A physiotherapist will supervise the rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-usual (TAU)
Intervention Description
The TAU program will be implemented after the initial assessment. It will consist of 2 components: An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms A school consultation to provide teacher education, recommend accommodations, and facilitate return to school
Primary Outcome Measure Information:
Title
Symptom Report
Description
The Post-Concussion Scale consists of 22 subjectively-experienced symptoms (e.g., headache, dizziness, concentration problems, and fogginess). A total score is derived from this 22-item scale. Athletes report symptoms based on the severity of each symptom that day, allowing tracking of symptoms over very short intervals
Time Frame
Baseline
Title
Symptom Report
Time Frame
At 8 weeks (end-of-treatment)
Secondary Outcome Measure Information:
Title
Mood
Description
The Beck Depression Inventory for Youth-Second Edition is a 20-item depression screening test designed for children and adolescents.
Time Frame
Baseline
Title
Energy level
Description
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used to monitor fatigue in the study participants, another commonly reported complaint after a MTBI. The PedsQL was designed to measure fatigue in pediatric patients; it includes a General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items).
Time Frame
Baseline
Title
Balance Testing
Description
The Balance Error Scoring System (BESS) is a commonly used measure of static balance and postural stability. The test is rapid, relatively easy-to-administer, and inexpensive. A combination of three stances (narrow double leg stance; single leg stance; and tandem stance) and footing surfaces (firm surface/floor or medium density foam) are used for the test. Each stance is held, with hands on hips and eyes closed, for 20 seconds. "Error" points are given for specific behaviors, including opening eyes, lifting hands off hips, or stepping, stumbling, or falling. Safety Issue: Falls and fall-related injuries. Testing will be supervised by a registered physiotherapist.
Time Frame
Baseline
Title
Neurocognitive Testing
Description
ImPACT is a computerized neuropsychological test battery that consists of six individual test modules that measure multiple aspects of cognitive functioning including attention, memory, working memory, visual scanning, reaction time, and processing speed. The test takes 20-25 minutes. Four composite (i.e., summary) scores are tabulated based upon these individual test scores: Verbal Memory, Visual Memory, Reaction Time, and Processing Speed.
Time Frame
Baseline
Title
Return to School and Sport
Description
Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals.
Time Frame
Baseline
Title
Mood
Description
The Beck Depression Inventory for Youth-Second Edition will be used
Time Frame
At 8 weeks (end-of-treatment)
Title
Energy level
Description
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used
Time Frame
At 8 weeks (end-of-treatment)
Title
Balance Testing
Description
The Balance Error Scoring System (BESS) will be used
Time Frame
At 8 weeks (end-of-treatment)
Title
Neurocognitive Testing
Description
ImPACT will be used.
Time Frame
At 8 weeks (end-of-treatment)
Title
Return to School and Sport
Description
Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals.
Time Frame
At 8 weeks (end-of-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adolescents referred to G. F. Strong Rehabilitation Centre (GFS) for atypical recovery preventing them from entering standard return to activities protocols will be recruited on a voluntary basis to participate in this study. Eligibility criteria for study entry are as follows: sustained an injury in sports, are 4 weeks post injury, report 2+ persistent post-concussion symptoms with no significant improvement over the past week, are between the ages of 14 and 18, have no developmental, congenital, or cognitive diagnoses, have no active mental health disorders, are able to attend at GFS, speak English as their dominant language, have no prior moderate or severe TBI, have no concussion in the 6 months before the present injury, and medical clearance by the study physician.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Chan, MPT
Phone
(604) 734-1313
Email
Catherine.chan2@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Chan, Physiotherapy
Organizational Affiliation
GF Strong Rehab Centre - Vancouver Coastal Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grant Iverson, Ph.D
Organizational Affiliation
University of British Columbia, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
GF Strong Rehabilitation Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Chan, MPT
Phone
(604) 734-1313
Email
Catherine.chan2@vch.ca
First Name & Middle Initial & Last Name & Degree
Catherine Chan, MPT

12. IPD Sharing Statement

Citations:
PubMed Identifier
28989074
Citation
Chan C, Iverson GL, Purtzki J, Wong K, Kwan V, Gagnon I, Silverberg ND. Safety of Active Rehabilitation for Persistent Symptoms After Pediatric Sport-Related Concussion: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):242-249. doi: 10.1016/j.apmr.2017.09.108. Epub 2017 Oct 5.
Results Reference
derived

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Exercise for Adolescents Following Sport-Related Concussion: A Randomized Control Trial

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