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| Name | Class |
|---|---|
| University College Copenhagen | OTHER |
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This project evaluates and quantifies the effects of an individually tailored exercise program applied to patients with long-lasting symptoms after concussion, minor traumatic brain injury, so-called Post-Concussion Syndrome (PCS). The project investigates the phenomenon Post Concussion Syndrome in four dimensions with a focus on both patient perspectives of PCS, an interventional physical program, a neurobiological basis for PCS through Magnetic Resonance Imaging (MRI) and finally through a 360-degree evaluation of the entire project involving patients and scientists in a reflective process.
The project has four parts
Aims and hypotheses:
Methods - the four parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobe graded physical exercise intervention and usual care | Experimental | Physical exercise program. The experimental programme is an add-on to usual care and consists of an aerobe graded exercise program performed twice a week for 12 weeks. Usual care includes all public treatments that each patient is assigned to at entry to REPCon. The provision of officially available treatments follow the Danish Health Care Act. |
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| Usual care | Placebo Comparator | No physical exercise program in a patient control group with PCS. This group continues with usual care, but all clinical test, interviews and MRI protocol are the same. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise programme as an add-on | Other | Consists of an individually tailored bike exercise program guided by symptoms, pulse rate and patient specific judgement of exertion monitored also by BORG RPE and VAS and progressively increasing time and level of resistance below symptom provocation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Buffalo Concussion Bike Test from baseline measurement to week 12 | Buffalo Concussion Bike Test is an individualized bike test designed to measure the number of minutes that the patient can cycle without symptom aggrevation. The test is stopped when symptoms worsen judged by VAS, BORG RPE and pulse rate. The result is measured in minutes | Change in Buffalo Concussion Bike Test at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Rivermead Post Concussion Questionaire from baseline to week 12 | A systematic questionary related to patient perception of commotio during past 24 hours. Result is in point with a maximum possible score of 3 and 13 points | Change in point score at week 12 |
| Changes in Fatique Scale Questionaire from baseline to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrik BW Larsson, Professor | Contact | (+45) 24824294 | henrik.bo.wiberg.larsson@regionh.dk | |
| Mette K Zebis, PhD | Contact | (+45) 30291943 | mzeb@kp.dk |
| Name | Affiliation | Role |
|---|---|---|
| Henrik BW Larsson, Professor | Faculty of Health and Medical Science, University of Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Copenhagen | Recruiting | Copenhagen | Region of Greater Copenhagen | 1799 | Denmark |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
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Patients are recruited through our professional networks, via clinics, hospital emergency departments, general practitioners, physiotherapeutic clinics, flyers at educational institutions and patient associations. Inclusion age is 18-70 years, both genders. PCS symptoms of at least 4 weeks persistence after initial trauma and patients must be able to document the traumatic brain event from either emergency room or other medical doctor. Exclusion criteria: other diseases interfering with presentation of PCS symptoms.
Up to fifty healthy controls are included only in the MRI part. Healthy controls are recruited by advertising in public media. This part of the project is also constituted as a separate case control study comparing PCS patients and healthy controls
Seventy patients with PCS are randomized to either intervention as an add on to usual care or to control. Randomization is performed as a block-randomization with permuted block of size 2-6 generated via computer.
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The assessors of outcomes at the end of the project are different to the assessors of clinical test at entry to the project
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| Control patients receiving usual care | Other | No exercise intervention |
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A systematic questionary related to patient perception of fatique. Result is in points with a maximum possible score of 63 points |
| Change in point score at week 12 |
| Change in Buffalo Concussion Bike Test from baseline measurement to week 4 | Buffalo Concussion Bike Test is an individualized bike test designed to measure the number of minutes that the patient can cycle without symptom aggrevation. The test is stopped when symptoms worsen judged by VAS, BORG RPE and pulse rate. The result is measured in minutes | Change in Buffalo Concussion Bike Test at week 4 |
| Change in Buffalo Concussion Bike Test from baseline to week 8 | Buffalo Concussion Bike Test is an individualized bike test designed to measure the number of minutes that the patient can cycle without symptom aggrevation. The test is stopped when symptoms worsen judged by VAS, BORG RPE and pulse rate. The result is measured in minutes | Change in Buffalo Concussion Bike Test at week 8 |
| Description of patient perspectives of living with PCS | In a grounded theory frame we develop new descriptions of patient experiences | Assessed at week 12 |
| Evaluation of the project | In a SWOT analyses frame we develop qualitative concepts of the project | After completion of the 12 week intervention |
| Change in Sms tracking domain one: "Physical Ability" of self reported well being in relation to commotio | All included patients fill out an electronic questionary related to five domains of well being. Result of score is a number from 0 to 10 | Change in perceived physical ability at week 12 |
| Change in Sms tracking domain two: "Overall physical symptoms" of self reported well being in relation to commotio | All included patients fill out an electronic questionary related to five domains of well being. Result of score is a number from 0 to 10 | Change in perceived overall physical symptoms at week 12 |
| Change in Sms tracking domain three: "Using the brain" of self reported well being in relation to commotio | All included patients fill out an electronic questionary related to five domains of well being. Result of score is a number from 0 to 10 | Change in perception of "using the brain" at week 12 |
| Change in Sms tracking domain four: "Work ability" of self reported well being in relation to commotio | All included patients fill out an electronic questionary related to five domains of well being. Result of score is a number from 0 to 10 | Change in perception of work ability |
| Change in Sms tracking domain five: "Quality of daily living" of self reported well being in relation to commotio | All included patients fill out an electronic questionary related to five domains of well being. Result of score is a number from 0 to 10 | Change in perception of quality of daily life |
| Changes in Dynamic Gait Index Questionaire from baseline to week 12 | A systematic questionaire related to functional and dynamic balance during gait. Result of score is in points with a maximum of 24 points | Change in dynamic gait at week 12 |
| Change in blood brain barrier permeability from baseline to week 12 | Normalization of blood brain barrier permeability in the intervention group. Blood brain barrier permeability measured in mLiter/minute/mLiter of brain tissue (mL/min/mL) | Change in blood brain barrier permeability at week 12 |
| Change of brain oxygen consumption from baseline to week 12 | Normalization of oxygen consumption in the intervention group. Measured in unit mmol oxygen/minute/ mLiter of brain tissue (mmol/min/mL). | Change of brain oxygen consumption at week 12 |
| Change of brain diffusion from baseline to week 12 | Normalization of brain diffusion in the post concussion intervention patient group. Diffusion coefficient is measured in meter^2/second (m^2/s). | Change of brain diffusion at week 12 |
| Change of brain lactate from baseline to week 12 | Normalization of lactate in the intervention group. Measurement of lactate in mmol/ml brain tissue. | Change of brain lactate at week 12 |
| Case- control comparison; Blood brain barrier permeability | Blood brain barrier permeability measurement comparison between healthy controls and patients with post concussion syndrome. Measurement in mLiter/minute/mLiter of brain tissue (mL/min/mL) | Comparison measurements at baseline |
| Case-control comparison; Brain oxygen consumption | Global brain oxygen consumption normalized to total brain volume comparison between healthy controls and patients with post concussion syndrome. Measured in unit mmol oxygen/minute/ mLiter of brain tissue (mmol/min/mL) | Comparison measurements at baseline |
| Case-control comparison; Brain diffusion coefficient | Brain water diffusion coefficient comparison between healthy controls and patients with post concussion syndrome. Diffusion coefficient measured in meter^2/second (m^2/s). | Comparison measurements at baseline |
| Case-control comparison; Brain lactate | Measurement of brain lactate in precuneus comparison between healthy controls and patients with post concussion syndrome. Measurement in mmol/ml brain tissue. | Comparison measurements at baseline |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |