Post-Concussion SyndromeREPConNCT05785000
Rehabilitation in Post Concussion Syndrome
A study testing Physical exercise programme as an add-on in people with Post-Concussion Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Physical exercise programme as an add-on
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other diseases blurring the diagnose PCS
- Other serious brain diseases
- Severe cardiovascular diseases precluding physical activity according to protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
University College Copenhagen
Copenhagen, Region of Greater Copenhagen, 1799
Mette K Zebis, Affiliate Professor, +45 51632437, mzeb@kp.dk
Henrik BW Larsson, Professor, +45 38632432, henrik.bo.wiberg.larsson@regionh.dk
About this study
Official title: Rehabilitation of Adult Patients With Post Concussion Syndrome
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.
Read the 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.
- Conditions
- Post-Concussion Syndrome
- Being tested
- Physical exercise programme as an add-on, Control patients receiving usual care
- Keywords
- Mild traumatic brain injury, Brain function, Magnetic Resonance Imaging, Buffalo Concussion Bike Test, Patient perception, 360-degree evaluation
- Medical subject headings
- Post-Concussion Syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise programme as an add-onOther
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
Control patients receiving usual careOther
No exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical exercise programme as an add-on |
| 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. Receives: Other: Control patients receiving usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change in Buffalo Concussion Bike Test at week 12
Secondary outcomes (20)
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
Measured: Change in point score at week 12
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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed at week 12
Evaluation of the project
In a SWOT analyses frame we develop qualitative concepts of the project
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: Comparison measurements at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2025
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Copenhagen University Hospital, RigshospitaletThe 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
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University College Copenhagen
- Responsible party
- Principal investigator, Henrik Bo Wiberg Larsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik BW Larsson, Professor, Principal investigator, Faculty of Health and Medical Science, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785000
- Sponsor's protocol ID
- Repcon123
- Acronym
- REPCon
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsson BW, Zebis MK, Vismann J, Orner FF, Tireli ED, Clausen KD, Fenger I, Shacham DA, Tireli D, Haraldsson BT, Cramer SP, Lindberg U, Vestergaard MB, Sylliaas H, Amin FM, Larsson HBW. Rehabilitation Involving Tailored Subsymptomatic Aerobic Exercise in Adult Patients With Persistent Postconcussion Symptoms (REPCon Project): Protocol for an Assessor-Blinded, Parallel-Group, Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 4;15:e93795. doi: 10.2196/93795.
PubMed 42241591
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Adult Patients With Post Concussion Syndrome
- ClinicalTrials.gov ID
- NCT05785000
- Acronym / sponsor ID
- REPCon / Repcon123
- Conditions
- Post-Concussion Syndrome
- Keywords
- Mild traumatic brain injury, Brain function, Magnetic Resonance Imaging, Buffalo Concussion Bike Test, Patient perception, 360-degree evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University College Copenhagen
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 27 Mar 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobe graded physical exercise intervention and usual care | Experimental | Other: Physical exercise programme as an add-onPhysical 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. |
| Usual care | Placebo comparator | Other: Control patients receiving usual careNo 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Other diseases blurring the diagnose PCS
- Other serious brain diseases
- Severe cardiovascular diseases precluding physical activity according to protocol
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 |
|---|---|---|
| Physical exercise programme as an add-onConsists 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 | Other | Aerobe graded physical exercise intervention and usual care |
| Control patients receiving usual careNo exercise intervention | Other | Usual care |
Primary outcome
Change in Buffalo Concussion Bike Test from baseline measurement to week 12
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
20 secondary outcomes
Changes in Rivermead Post Concussion Questionaire from baseline to week 12
Time frame: Change in point score at week 12
Changes in Fatique Scale Questionaire from baseline to week 12
Time frame: Change in point score at week 12
Change in Buffalo Concussion Bike Test from baseline measurement to week 4
Time frame: Change in Buffalo Concussion Bike Test at week 4
Change in Buffalo Concussion Bike Test from baseline to week 8
Time frame: Change in Buffalo Concussion Bike Test at week 8
Description of patient perspectives of living with PCS
Time frame: Assessed at week 12
Evaluation of the project
Time frame: After completion of the 12 week intervention
Change in Sms tracking domain one: "Physical Ability" of self reported well being in relation to commotio
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change in perception of quality of daily life
Changes in Dynamic Gait Index Questionaire from baseline to week 12
Time frame: Change in dynamic gait at week 12
Change in blood brain barrier permeability from baseline to week 12
Time frame: Change in blood brain barrier permeability at week 12
Change of brain oxygen consumption from baseline to week 12
Time frame: Change of brain oxygen consumption at week 12
Change of brain diffusion from baseline to week 12
Time frame: Change of brain diffusion at week 12
Change of brain lactate from baseline to week 12
Time frame: Change of brain lactate at week 12
Case- control comparison; Blood brain barrier permeability
Time frame: Comparison measurements at baseline
Case-control comparison; Brain oxygen consumption
Time frame: Comparison measurements at baseline
Case-control comparison; Brain diffusion coefficient
Time frame: Comparison measurements at baseline
Case-control comparison; Brain lactate
Time frame: Comparison measurements at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 42241591Larsson BW, Zebis MK, Vismann J, Orner FF, Tireli ED, Clausen KD, Fenger I, Shacham DA, Tireli D, Haraldsson BT, Cramer SP, Lindberg U, Vestergaard MB, Sylliaas H, Amin FM, Larsson HBW. Rehabilitation Involving Tailored Subsymptomatic Aerobic Exercise in Adult Patients With Persistent Postconcussion Symptoms (REPCon Project): Protocol for an Assessor-Blinded, Parallel-Group, Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 4;15:e93795. doi: 10.2196/93795.
- Individual participant dataSharing planned: No
Related trials for Post-Concussion Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
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.
Henrik BW Larsson, Professor principal investigator
Faculty of Health and Medical Science, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise programme as an add-on in people with Post-Concussion Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrik BW Larsson, Professor ((+45) 24824294, henrik.bo.wiberg.larsson@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Buffalo Concussion Bike Test from baseline measurement to week 12 (time frame: Change in Buffalo Concussion Bike Test at week 12). 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 NCT05785000, which also lists 1 linked publication.
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 22 Jan 2026.