Post Concussion SyndromeNCT02459145
Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome
A study testing Graduated exercise protocol in people with Post Concussion Syndrome, run by University of Arizona at 1 site in United States.
Trial summary
The general consensus in sports medicine demonstrates a graduated return to activity protocol for individuals with post-concussion syndrome. This is commonly practiced but there is insufficient literature to indicate evidence-based practice. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Post Concussion Syndrome
- What is being tested?
- Graduated exercise protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to May 2017
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 13 and 18 (freshman - senior)
- Subject must be able to understand and sign assent form and parent/guardian must be able to understand and sign consent form
- Initial injury meets the definition of mTBI as follows:
- Traumatically induced physiological disruption of brain function by at least one of the following: i. Any period of loss of consciousness of 30 minutes or less ii. Any loss of memory for events immediately before or after accident and post-traumatic amnesia not greater than 24 hours iii. Any alteration in mental state at time of accident b. No structural lesions in the head or brain
- Diagnosed with post concussive syndrome as follows:
- Clinical SCAT-3 revised score of >22 at 3+ weeks or plateaued score for 2 weeks or more of >15 at 4+ weeks
Show all 9Show fewer
- Continues to experience symptoms post injury and at time of enrollment
- Has had a normal MRI
- Can commit to participating for 12 weeks
Who cannot join
- Subjects who meet any of the following criteria will be excluded from study participation:
- Any documented structural lesions in the skull or brain
- Borderline TBI or concern that TBI is moderate rather than mild
- Any medication or condition that elevates heart rate
Trial locations and contacts
1 site in 1 country.
About this study
The general consensus in sports medicine demonstrates a graduated return to activity protocol for individuals with post-concussion syndrome. This is commonly practiced but there is insufficient literature to indicate evidence-based practice. This study will provide evidence of the effectiveness of the clinical gradual return to exercise protocols beginning after diagnosis of post-concussion syndrome through standardization and measurement of outcomes.
Read the detailed description
Concussion is referred to as a mild form of traumatic brain injury (mTBI) that can result in temporary loss of consciousness, memory, or awareness. mTBI can also cause physiologic symptoms such as nausea or vomiting, headaches, vestibulo-ocular dysfunction, and balance errors. The majority of individuals with mTBI will fully recover within a 7-10 day period, although adolescents may require more time to recover than adults. The American Medical Society for Sports Medicine (AMSSM) position statement on concussion management indicates that there are no standardized guidelines for return to school and return to play recommendations involve a graduated activity program once all symptoms have resolved.[1] Treatment varies amongst physicians, but it is widely held that a minimum of 5 days strict rest at home (specifically, no school, work, or physical activity) followed by a stepwise return to activity. Recent articles, however have questioned the validity of strict rest for that many days as for other similar injuries (whiplash) recommendations involve attempts to gradually resume normal activities of daily living.[2]
Individuals whose concussion symptoms do not resolve within 7-10 days are considered to have post concussion syndrome (PCS) which is ill-defined and poorly understood, however the AMSSM describes the benefit of supervised progressive exercise programs that increase tolerance as symptoms permit. The protocols in the literature for adults involve assessing the maximum threshold at which symptoms are exacerbated then have individuals perform supervised exercise at 80% of that rate,[3, 4] however this has not been done in the pediatric population and most pediatric physicians instead perform graduated activity protocols starting at a lower thresholds and increasing unless an exacerbation occurs (SORT Level of Evidence C).[5, 6] It is proposed that the fundamental cause of PCS is physiological dysfunction that fails to return to normal after a concussion. Essentially patients with a concussion are in a state of sympathetic nervous system predominance. This results in the subsequent altering of autonomic function and impaired cerebral auto regulation.[7] Aerobic exercise training may help concussion-related physiological dysfunction because exercise increases parasympathetic activity, reduces sympathetic activation, and improves cerebral blood flow. Recent articles have compared rest to activity and found slower recovery from PCS in most of the rest groups.[8]
The aim of this research is to provide documentation in the literature for an adolescent graduated activity protocol that is currently practiced in the University of Arizona Pediatric Sports Medicine Clinic.
- Conditions
- Post Concussion Syndrome
- Being tested
- Graduated exercise protocol
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated exercise protocolBehavioural
Intervention involves exercise protocols starting at 50% of maximum age-adjusted heart rate (MHR) for 10 minutes (warm-up and Recovery)_ plus 5 minutes of target heart rate per day 5 days a week for 2 weeks, supervised by the athletic trainer or parent. The protocol increases the intensity of target heart rate by 10% MHR and duration of 50% MHR by 2 minutes every 2 weeks if there is no symptom exacerbation.
| Study group | Role | What they receive |
|---|---|---|
| Graduated Exercise Protocol | Active comparator | Intervention involves exercise starting at 50% of maximum age-adjusted heart rate (MHR) for 10 minutes (warm-up and Recovery)_ plus 5 minutes of target heart rate per day 5 days a week for 2 weeks, supervised by the athletic trainer or parent. The protocol increases the intensity of target heart rate by 10% MHR and duration of 50% MHR by 2 minutes every 2 weeks if there is no symptom exacerbation. The exercise protocol includes treadmill speed and track minutes per lap conversion, rate of perceived exertion and talk test for each stage of exercise plus total time to execute for 5 days each week. Receives: Behavioral: Graduated exercise protocol |
| Rest followed by Protocol | Other | No activity in weeks 1 - 8. In week 9 we will begin their intervention phase as described in graduated exercise protocol Receives: Behavioral: Graduated exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in symptoms
Depression Anxiety Stress Scale and ImPACT Symptom Severity Scale
Measured: 12 weeks
Secondary outcomes (1)
Improvement in Neuropsychological testing performance
ImPACT
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: PI Left Insitution - study no RCT
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sydney A Rice, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459145
- Sponsor's protocol ID
- PCS0001
- Status last verified
- Jan 2016
- First submitted
- 19 May 2015
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Harmon KG, Drezner JA, Gammons M, Guskiewicz KM, Halstead M, Herring SA, Kutcher JS, Pana A, Putukian M, Roberts WO. American Medical Society for Sports Medicine position statement: concussion in sport. Br J Sports Med. 2013 Jan;47(1):15-26. doi: 10.1136/bjsports-2012-091941.
PubMed 23243113Craton N, Leslie O. Is rest the best intervention for concussion? Lessons learned from the whiplash model. Curr Sports Med Rep. 2014 Jul-Aug;13(4):201-4. doi: 10.1249/JSR.0000000000000072. No abstract available.
PubMed 25014382Leddy JJ, Kozlowski K, Donnelly JP, Pendergast DR, Epstein LH, Willer B. A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Clin J Sport Med. 2010 Jan;20(1):21-7. doi: 10.1097/JSM.0b013e3181c6c22c.
PubMed 20051730Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.
PubMed 23479489
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome
- ClinicalTrials.gov ID
- NCT02459145
- Acronym / sponsor ID
- PCS0001
- Conditions
- Post Concussion Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Left Insitution - study no RCT
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general consensus in sports medicine demonstrates a graduated return to activity protocol for individuals with post-concussion syndrome. This is commonly practiced but there is insufficient literature to indicate evidence-based practice. This study will provide evidence of the effectiveness of the clinical gradual return to exercise protocols beginning after diagnosis of post-concussion syndrome through standardization and measurement of outcomes.
Detailed description
Concussion is referred to as a mild form of traumatic brain injury (mTBI) that can result in temporary loss of consciousness, memory, or awareness. mTBI can also cause physiologic symptoms such as nausea or vomiting, headaches, vestibulo-ocular dysfunction, and balance errors. The majority of individuals with mTBI will fully recover within a 7-10 day period, although adolescents may require more time to recover than adults. The American Medical Society for Sports Medicine (AMSSM) position statement on concussion management indicates that there are no standardized guidelines for return to school and return to play recommendations involve a graduated activity program once all symptoms have resolved.[1] Treatment varies amongst physicians, but it is widely held that a minimum of 5 days strict rest at home (specifically, no school, work, or physical activity) followed by a stepwise return to activity. Recent articles, however have questioned the validity of strict rest for that many days as for other similar injuries (whiplash) recommendations involve attempts to gradually resume normal activities of daily living.[2]
Individuals whose concussion symptoms do not resolve within 7-10 days are considered to have post concussion syndrome (PCS) which is ill-defined and poorly understood, however the AMSSM describes the benefit of supervised progressive exercise programs that increase tolerance as symptoms permit. The protocols in the literature for adults involve assessing the maximum threshold at which symptoms are exacerbated then have individuals perform supervised exercise at 80% of that rate,[3, 4] however this has not been done in the pediatric population and most pediatric physicians instead perform graduated activity protocols starting at a lower thresholds and increasing unless an exacerbation occurs (SORT Level of Evidence C).[5, 6] It is proposed that the fundamental cause of PCS is physiological dysfunction that fails to return to normal after a concussion. Essentially patients with a concussion are in a state of sympathetic nervous system predominance. This results in the subsequent altering of autonomic function and impaired cerebral auto regulation.[7] Aerobic exercise training may help concussion-related physiological dysfunction because exercise increases parasympathetic activity, reduces sympathetic activation, and improves cerebral blood flow. Recent articles have compared rest to activity and found slower recovery from PCS in most of the rest groups.[8]
The aim of this research is to provide documentation in the literature for an adolescent graduated activity protocol that is currently practiced in the University of Arizona Pediatric Sports Medicine Clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graduated Exercise Protocol | Active comparator | Behavioral: Graduated exercise protocolIntervention involves exercise starting at 50% of maximum age-adjusted heart rate (MHR) for 10 minutes (warm-up and Recovery)_ plus 5 minutes of target heart rate per day 5 days a week for 2 weeks, supervised by the athletic trainer or parent. The protocol increases the intensity of target heart rate by 10% MHR and duration of 50% MHR by 2 minutes every 2 weeks if there is no symptom exacerbation. The exercise protocol includes treadmill speed and track minutes per lap conversion, rate of perceived exertion and talk test for each stage of exercise plus total time to execute for 5 days each week. |
| Rest followed by Protocol | Other | Behavioral: Graduated exercise protocolNo activity in weeks 1 - 8. In week 9 we will begin their intervention phase as described in graduated exercise protocol |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Between the ages of 13 and 18 (freshman - senior)
- Subject must be able to understand and sign assent form and parent/guardian must be able to understand and sign consent form
- Initial injury meets the definition of mTBI as follows:
- Diagnosed with post concussive syndrome as follows:
- Continues to experience symptoms post injury and at time of enrollment
Key exclusion criteria (4 listed)
- Subjects who meet any of the following criteria will be excluded from study participation:
- Any documented structural lesions in the skull or brain
- Borderline TBI or concern that TBI is moderate rather than mild
- Any medication or condition that elevates heart rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graduated exercise protocolIntervention involves exercise protocols starting at 50% of maximum age-adjusted heart rate (MHR) for 10 minutes (warm-up and Recovery)_ plus 5 minutes of target heart rate per day 5 days a week for 2 weeks, supervised by the athletic trainer or parent. The protocol increases the intensity of target heart rate by 10% MHR and duration of 50% MHR by 2 minutes every 2 weeks if there is no symptom exacerbation. | Behavioural | Graduated Exercise Protocol, Rest followed by Protocol |
Primary outcome
Reduction in symptoms
Time frame: 12 weeks
Depression Anxiety Stress Scale and ImPACT Symptom Severity Scale
1 secondary outcome
Improvement in Neuropsychological testing performance
Time frame: 12 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Background: PubMed 23243113Harmon KG, Drezner JA, Gammons M, Guskiewicz KM, Halstead M, Herring SA, Kutcher JS, Pana A, Putukian M, Roberts WO. American Medical Society for Sports Medicine position statement: concussion in sport. Br J Sports Med. 2013 Jan;47(1):15-26. doi: 10.1136/bjsports-2012-091941.
- Background: PubMed 25014382Craton N, Leslie O. Is rest the best intervention for concussion? Lessons learned from the whiplash model. Curr Sports Med Rep. 2014 Jul-Aug;13(4):201-4. doi: 10.1249/JSR.0000000000000072. No abstract available.
- Background: PubMed 20051730Leddy JJ, Kozlowski K, Donnelly JP, Pendergast DR, Epstein LH, Willer B. A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Clin J Sport Med. 2010 Jan;20(1):21-7. doi: 10.1097/JSM.0b013e3181c6c22c.
- Background: PubMed 23479489Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney A Rice, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated exercise protocol in people with Post Concussion Syndrome, run by University of Arizona at 1 site in United States.
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 9 inclusion and 4 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 26 Jan 2016. 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 United States. 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. 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?
Reduction in symptoms (time frame: 12 weeks). 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 NCT02459145, which also lists 4 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 26 Jan 2016.