Post-Concussion Aerobic Exercise

December 12, 2023 updated by: University Health Network, Toronto

The Effects of Early Prescribed Aerobic Exercise on Recovery and Post-concussive Symptoms in Adults

This study is looking at the specific role of an exercise prescription on recovery from concussion symptoms in the general population.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

435 people will participate in this study.

A physician will review a participant's medical history to determine if physical activity is appropriate for them. They will then be randomly assigned to 1 of 3 study groups:

  1. Monitoring- participants will be given a heart rate monitor to wear on their wrist for the duration of the study (until "recovered", or until 8 weeks post-concussion, whatever comes first).
  2. Monitoring + Treadmill Testing- in addition to wearing the heart rate monitor, they will undergo a treadmill test at each appointment.
  3. Monitoring + Treadmill Testing + Specific Exercise Prescription- in addition to wearing the heart rate monitor, and treadmill test, they will receive an exercise prescription based on the results of the treadmill test.

The randomization is by chance. Participants have a 40/20/40% respective chance of being assigned to the study groups above. This means that out of every 5 people: 2 people will be assigned to the group 1, 1 will be assigned to the group 2, and 2 will be assigned to the group 3. Both participants and the study doctor will be aware which group participants are in.

Regardless of the group assigned, participants will receive an exercise prescription form at each appointment, as per usual care. The prescription will be based on the physician's judgement. If a participant is in group 3, their prescription will also take into account the results of the treadmill test.

Recovery will be determined using a 3-step approach:

  1. Self-reported symptoms,
  2. Clinic physician's opinion,
  3. Treadmill test results (if applicable).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2A2
        • Toronto Rehabilitation Institute - University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients that provide written informed consent prior to entry into the study
  • Patients referred from the emergency department (ED) with recent (<1 week) diagnosis of concussion by ED physician
  • GCS score of 13-15 on presentation to the ED
  • SCAT score > 9 at week 1
  • Physician cleared for exercise; low risk for cardiac disease (defined as no cardiopulmonary symptoms and meet no more than one risk factor for heart disease)
  • Willing to exercise

Exclusion Criteria:

  • Evidence of intracranial hemorrhage, contusion or injury on brain imaging (CT Scan)
  • Beta-blocker medication
  • High dose (>50mg/day) tricyclic antidepressant medication
  • Pre-existing or current orthopedic injuries preventing exercise
  • Pre-existing vestibular disease preventing exercise
  • Heartrate increase <30 bpm from rest on treadmill test
  • Deemed asymptomatic from concussion by clinic physician
  • Unable/unwilling to follow commands

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Monitoring
Participants will be given a heart rate monitor to wear on their wrist for the duration of the study (i.e. until recovered, or 8 weeks post-injury, whatever comes first).
Device: Monitoring
Activity monitoring using a Fitbit.
Placebo Comparator: Monitoring + Treadmill Test
In addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.
Device: Monitoring
Activity monitoring using a Fitbit.
Behavioral: Treadmill Test
A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
Experimental: Monitoring + Treadmill Test + Specific Exercise Prescription
In addition to wearing the heart rate monitor, and completing a treadmill test at each appointment, participants will receive an exercise prescription based on the results of the treadmill test. They will be prescribed 30 minutes of structured aerobic exercise, 5 times per week, at a heart rate determined by their treadmill test.
Device: Monitoring
Activity monitoring using a Fitbit.
Behavioral: Treadmill Test
A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
Behavioral: Exercise Prescription
A specific exercise prescription, based on the results of a treadmill test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Recovered
Time Frame: Assessed at week 8 post-concussion.

"Recovery" (yes/no) will be determined using a 3-step approach:

  1. Self-reported symptoms (using the Sport Concussion Assessment Tool [SCAT], Symptom Inventory),
  2. Clinic physician's opinion,
  3. Treadmill test results (if applicable).
Assessed at week 8 post-concussion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Recovered
Time Frame: Assessed at week 2 post-concussion.
Assessed at week 2 post-concussion.
Percentage of Participants Recovered
Time Frame: Assessed at week 4 post-concussion.
Assessed at week 4 post-concussion.
Percentage of Participants who have Returned to Work/School
Time Frame: Assessed at week 2 post-concussion.
Time at which participants return to part-time and/or full-time work or school activities.
Assessed at week 2 post-concussion.
Percentage of Participants who have Returned to Work/School
Time Frame: Assessed at week 4 post-concussion.
Assessed at week 4 post-concussion.
Percentage of Participants who have Returned to Work/School
Time Frame: Assessed at week 8 post-concussion.
Assessed at week 8 post-concussion.
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Time Frame: Assessed at week 2 post-concussion.

Measured using the Brief Symptom Inventory (BSI)-18. Global scores, as well as somatization, depression, and anxiety sub-scales will be included.

Global scores are calculated by adding up participants self-reported score (0-72), with high scores indicating more psychological distress. These scores are then compared to gender-stratified norms. Sub-scales are scored on a 0-24 scale, again higher scores indicating more psychological distress (sub-scales also compared to gender-stratified norms).
Assessed at week 2 post-concussion.
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Time Frame: Assessed at week 4 post-concussion.
Assessed at week 4 post-concussion.
Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score
Time Frame: Assessed at week 8 post-concussion.
Assessed at week 8 post-concussion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Mark Bayley, MD, University Health Network, Toronto Rehabilitation Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-5899
  • 15-9214 (Other Identifier: University Health Network REB - Legacy ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IDP sharing plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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