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Rehabilitation in Post Concussion Syndrome (REPCon)

Primary Purpose

Post-Concussion Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical exercise programme as an add-on
Control patients receiving usual care
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Mild traumatic brain injury, Brain function, Magnetic Resonance Imaging, Buffalo Concussion Bike Test, Patient perception, 360-degree evaluation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Post concussion syndrome (PCS) diagnose according to WHO ICD-10 classification and documented by written statement from physician veritying a mild traumatic brain injury Longer lasting symptoms for at least 4 weeks after initial trauma If allocated to add-on exercise protocol participant must feel able to prioritize the intervention structure Communication language must be Danish Exclusion Criteria: Other diseases blurring the diagnose PCS Other serious brain diseases Severe cardiovascular diseases precluding physical activity according to protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Aerobe graded physical exercise intervention and usual care

    Usual care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Changes in Fatique Scale Questionaire from baseline to week 12
    A systematic questionary related to patient perception of fatique. Result is in points with a maximum possible score of 63 points
    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 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
    Description of patient perspectives of living with PCS
    In a grounded theory frame we develop new descriptions of patient experiences
    Evaluation of the project
    In a SWOT analyses frame we develop qualitative concepts of the project
    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 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 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 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 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
    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 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 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 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 lactate from baseline to week 12
    Normalization of lactate in the intervention group. Measurement of lactate in mmol/ml brain tissue.
    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)
    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)
    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).
    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.

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    March 23, 2023
    Sponsor
    Rigshospitalet, Denmark
    Collaborators
    University College Copenhagen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05785000
    Brief Title
    Rehabilitation in Post Concussion Syndrome
    Acronym
    REPCon
    Official Title
    Rehabilitation of Adult Patients With Post Concussion Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    April 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rigshospitalet, Denmark
    Collaborators
    University College Copenhagen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    The project has four parts Aims and hypotheses: The aim is to describe and nuance the subjective patient perceived aspects of living with PCS including the individual experiences of symptom provocation or relieve after the initial trauma. Part one is concept developing and involves qualitative in-depth interviews of patient experiences of obstacles for living a normal life with special emphasis of intolerance to activity and exercise. The aim is to assess the effects of adding a 12 week individually tailored pulse-controlled aerobe exercise program to usual care. The hypothesis is that it is possible to increase the physical capacity measured by the number of minutes of pulse-training without symptom provocation. By increasing the number of minutes the threshold value of symptom provocation will be moved upwards for a training group (TG) of patients compared to a control group (CG) who carry on in their usual activities and treatments here defined as usual care. The aim is to measure quantitative components of the neurobiological aspects of PCS by magnetic resonance imaging (MRI). The hypothesis is that patients with PCS have more leakiness of the blood-brain barrier (BBB) compared to healthy controls. In addition, PCS patients have disturbance of brain metabolism, abnormal microstructural tissue organization and abnormal brain activity. Furthermore, that intervention will normalize these MRI metrics in a training group (TG) compared to a control group (CG). The aim is to obtain qualitative components of having patients and scientists evaluating the project. The evaluation will comprise participants involved, i.e. both patients in the 2 arms and researchers and the goal of this 360-degree evaluation is to describe perceived experiences of strength, weakness, possibility and threat (SWOT) of the intervention and ultimately prevent development of PSC after a minor traumatic brain injury. Methods - the four parts: Qualitative interviews of PCS participants focusing on individual perception of own situation, detailed symptom description, hindrance of living a normal life. All PSC patients continue daily living and own developed coping strategies. The intervention is an add-on. We use Short Message Service (SMS) tracking every week obtaining details of wellbeing related to living with concussion. The intervention consists of bi-weekly one hour exercise guided by physiotherapist for 12 weeks. Clinical status is performed four times- before and after 12 weeks and with two interim assessments. We use the validated Buffalo Concussion Bike Test (BCBT ). Blood pressure, pulse rate, pulse oxymetri and exercise level are registered and we use Visual Analog Scale (VAS) and BORG Ratings of Perceived Exertion (BORG RPE) scales. In addition we use the Rivermead Post Concussion Questionnaire (RPCQ ). Blood brain barrier (BBB) permeability is measured by Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) using a conventional MRI contrast agent. Both the leakiness (Ki) of the BBB, brain blood volume, capillary mean transit and distribution of transit times are estimated together with brain tissue perfusion (CBF). Other functional MRI measures are obtained such as the brain microstructural organization, measured by diffusion sensitive MRI and brain activity by Blood-oxygenation level dependent Imaging and brain lactate production as a measure of brain metabolism. The 360-degree evaluation of the entire project is a joint, narrative process where patients, researcher and students involved sit together using a process evaluating principle. A data triangulation and a reflection of pros and cons of the project will guide the process. The evaluation is guided by an expert in process evaluation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Concussion Syndrome
    Keywords
    Mild traumatic brain injury, Brain function, Magnetic Resonance Imaging, Buffalo Concussion Bike Test, Patient perception, 360-degree evaluation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    Outcomes Assessor
    Masking Description
    The assessors of outcomes at the end of the project are different to the assessors of clinical test at entry to the project
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aerobe graded physical exercise intervention and usual care
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual care
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Physical exercise programme as an add-on
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Control patients receiving usual care
    Intervention Description
    No exercise intervention
    Primary Outcome Measure Information:
    Title
    Change in Buffalo Concussion Bike Test from baseline measurement to week 12
    Description
    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 12
    Secondary Outcome Measure Information:
    Title
    Changes in Rivermead Post Concussion Questionaire from baseline to week 12
    Description
    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
    Title
    Changes in Fatique Scale Questionaire from baseline to week 12
    Description
    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 point score at week 12
    Title
    Change in Buffalo Concussion Bike Test from baseline measurement to week 4
    Description
    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 4
    Title
    Change in Buffalo Concussion Bike Test from baseline to week 8
    Description
    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
    Title
    Description of patient perspectives of living with PCS
    Description
    In a grounded theory frame we develop new descriptions of patient experiences
    Time Frame
    Assessed at week 12
    Title
    Evaluation of the project
    Description
    In a SWOT analyses frame we develop qualitative concepts of the project
    Time Frame
    After completion of the 12 week intervention
    Title
    Change in Sms tracking domain one: "Physical Ability" of self reported well being in relation to commotio
    Description
    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 physical ability at week 12
    Title
    Change in Sms tracking domain two: "Overall physical symptoms" of self reported well being in relation to commotio
    Description
    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
    Title
    Change in Sms tracking domain three: "Using the brain" of self reported well being in relation to commotio
    Description
    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
    Title
    Change in Sms tracking domain four: "Work ability" of self reported well being in relation to commotio
    Description
    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
    Title
    Change in Sms tracking domain five: "Quality of daily living" of self reported well being in relation to commotio
    Description
    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
    Title
    Changes in Dynamic Gait Index Questionaire from baseline to week 12
    Description
    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 dynamic gait at week 12
    Title
    Change in blood brain barrier permeability from baseline to week 12
    Description
    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 in blood brain barrier permeability at week 12
    Title
    Change of brain oxygen consumption from baseline to week 12
    Description
    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 oxygen consumption at week 12
    Title
    Change of brain diffusion from baseline to week 12
    Description
    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 diffusion at week 12
    Title
    Change of brain lactate from baseline to week 12
    Description
    Normalization of lactate in the intervention group. Measurement of lactate in mmol/ml brain tissue.
    Time Frame
    Change of brain lactate at week 12
    Title
    Case- control comparison; Blood brain barrier permeability
    Description
    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
    Title
    Case-control comparison; Brain oxygen consumption
    Description
    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
    Title
    Case-control comparison; Brain diffusion coefficient
    Description
    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
    Title
    Case-control comparison; Brain lactate
    Description
    Measurement of brain lactate in precuneus comparison between healthy controls and patients with post concussion syndrome. Measurement in mmol/ml brain tissue.
    Time Frame
    Comparison measurements at baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Post concussion syndrome (PCS) diagnose according to WHO ICD-10 classification and documented by written statement from physician veritying a mild traumatic brain injury Longer lasting symptoms for at least 4 weeks after initial trauma If allocated to add-on exercise protocol participant must feel able to prioritize the intervention structure Communication language must be Danish Exclusion Criteria: Other diseases blurring the diagnose PCS Other serious brain diseases Severe cardiovascular diseases precluding physical activity according to protocol
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Henrik BW Larsson, Professor
    Phone
    (+45) 24824294
    Email
    henrik.bo.wiberg.larsson@regionh.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mette K Zebis, PhD
    Phone
    (+45) 30291943
    Email
    mzeb@kp.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Henrik BW Larsson, Professor
    Organizational Affiliation
    Faculty of Health and Medical Science, University of Copenhagen, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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