University College Copenhagen
Copenhagen, Region of Greater Copenhagen, 1799, Denmark
Location status: Recruiting
Location contact
Henrik BW Larsson, Professor
CONTACT
Mette K Zebis, Affiliate Professor
CONTACT
NCT Number: NCT05785000
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Copenhagen, Region of Greater Copenhagen, 1799, Denmark
Location status: Recruiting
Henrik BW Larsson, Professor
CONTACT
Mette K Zebis, Affiliate Professor
CONTACT
The project has four parts
Aims and hypotheses:
Methods - the four parts:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
No exercise intervention
Time frame: Change in Buffalo Concussion Bike Test at 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
Time frame: Change in point score at 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
Time frame: Change in point score at week 12
A systematic questionary related to patient perception of fatique. Result is in points with a maximum possible score of 63 points
Time frame: Change in Buffalo Concussion Bike Test at 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
Time frame: Change in Buffalo Concussion Bike Test at 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
Time frame: Assessed at week 12
In a grounded theory frame we develop new descriptions of patient experiences
Time frame: After completion of the 12 week intervention
In a SWOT analyses frame we develop qualitative concepts of the project
Time frame: Change in perceived physical ability at week 12
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
Time frame: Change in perceived overall physical symptoms at week 12
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
Time frame: Change in perception of "using the brain" at week 12
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
Time frame: Change in perception of work ability
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
Time frame: Change in perception of quality of daily life
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
Time frame: Change in dynamic gait at 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
Time frame: Change in blood brain barrier permeability at 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)
Time frame: Change of brain oxygen consumption at week 12
Normalization of oxygen consumption in the intervention group. Measured in unit mmol oxygen/minute/ mLiter of brain tissue (mmol/min/mL).
Time frame: Change of brain diffusion at week 12
Normalization of brain diffusion in the post concussion intervention patient group. Diffusion coefficient is measured in meter^2/second (m^2/s).
Time frame: Change of brain lactate at week 12
Normalization of lactate in the intervention group. Measurement of lactate in mmol/ml brain tissue.
Time frame: Comparison measurements at baseline
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)
Time frame: Comparison measurements at baseline
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)
Time frame: Comparison measurements at baseline
Brain water diffusion coefficient comparison between healthy controls and patients with post concussion syndrome. Diffusion coefficient measured in meter^2/second (m^2/s).
Time frame: Comparison measurements at baseline
Measurement of brain lactate in precuneus comparison between healthy controls and patients with post concussion syndrome. Measurement in mmol/ml brain tissue.
Contact information is provided by the study sponsor or research team.
Henrik BW Larsson, Professor
CONTACT
(+45) 24824294
Mette K Zebis, PhD
CONTACT
(+45) 30291943
Rigshospitalet, Denmark
Other
Rehabilitation of Adult Patients With Post Concussion Syndrome
Acronym: REPCon
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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