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Concussion, MildNCT04539509

Post-Concussion Aerobic Exercise

A study testing Exercise Prescription, Treadmill Test and Monitoring in people with Concussion, Mild and Mild Traumatic Brain Injury, run by University Health Network, Toronto at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 17 to 55 years
Conditions the study is for
Concussion, Mild, Mild Traumatic Brain Injury
What is being tested?
Exercise Prescription, Treadmill Test and Monitoring
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteCanada
Study dates
1 Jan 2021to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Rehabilitation Institute - University Health Network

    Toronto, Ontario, M5G 2A2

Other trials in Canada

About this study

Official title: 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.

Read the 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).
Being tested
Exercise Prescription, Treadmill Test, Monitoring
Keywords
Concussion, Mild traumatic brain injury, Aerobic exercise
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise PrescriptionBehavioural

    A specific exercise prescription, based on the results of a treadmill test.

  • Treadmill TestBehavioural

    A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.

  • MonitoringDevice

    Activity monitoring using a Fitbit.

Study groups in NCT04539509
Study groupRoleWhat they receive
MonitoringActive comparatorParticipants 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).
Receives: Device: Monitoring
Monitoring + Treadmill TestPlacebo comparatorIn addition to wearing the heart rate monitor, participants will undergo a treadmill test at each appointment.
Receives: Behavioral: Treadmill Test; Device: Monitoring
Monitoring + Treadmill Test + Specific Exercise PrescriptionExperimentalIn 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.
Receives: Behavioral: Exercise Prescription; Behavioral: Treadmill Test; Device: Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Recovered

    "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).

    Measured: Assessed at week 8 post-concussion.

Secondary outcomes (8)

  1. Percentage of Participants Recovered

    Measured: Assessed at week 2 post-concussion.

  2. Percentage of Participants Recovered

    Measured: Assessed at week 4 post-concussion.

  3. Percentage of Participants who have Returned to Work/School

    Time at which participants return to part-time and/or full-time work or school activities.

    Measured: Assessed at week 2 post-concussion.

  4. Percentage of Participants who have Returned to Work/School

    Measured: Assessed at week 4 post-concussion.

  5. Percentage of Participants who have Returned to Work/School

    Measured: Assessed at week 8 post-concussion.

  6. Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score

    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).

    Measured: Assessed at week 2 post-concussion.

  7. Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score

    Measured: Assessed at week 4 post-concussion.

  8. Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score

    Measured: Assessed at week 8 post-concussion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2020
  2. Study start1 Jan 2021
  3. Primary completionAug 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: Revising study protocol.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04539509
Sponsor's protocol ID
20-5899
Other IDs
15-9214
Status last verified
Nov 2022
First submitted
19 Aug 2020
Last updated
13 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IDP sharing plan.

Publications

  • Haider MN, Leddy JJ, Wilber CG, Viera KB, Bezherano I, Wilkins KJ, Miecznikowski JC, Willer BS. The Predictive Capacity of the Buffalo Concussion Treadmill Test After Sport-Related Concussion in Adolescents. Front Neurol. 2019 Apr 24;10:395. doi: 10.3389/fneur.2019.00395. eCollection 2019.

    PubMed 31105634

  • Lawrence DW, Richards D, Comper P, Hutchison MG. Earlier time to aerobic exercise is associated with faster recovery following acute sport concussion. PLoS One. 2018 Apr 18;13(4):e0196062. doi: 10.1371/journal.pone.0196062. eCollection 2018.

    PubMed 29668716

  • Leddy JJ, Willer B. Use of graded exercise testing in concussion and return-to-activity management. Curr Sports Med Rep. 2013 Nov-Dec;12(6):370-6. doi: 10.1249/JSR.0000000000000008.

    PubMed 24225521

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Prescription, Treadmill Test and Monitoring in people with Concussion, Mild and Mild Traumatic Brain Injury, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Recovered (time frame: Assessed at week 8 post-concussion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04539509, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.

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