Rehabilitation in Post Concussion Syndrome

NCT ID: NCT05785000

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-04-30

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:

1. 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.

2. 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.

3. 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).

4. 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:

1. Qualitative interviews of PCS participants focusing on individual perception of own situation, detailed symptom description, hindrance of living a normal life.

2. 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 ).

3. 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.

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobe graded physical exercise intervention and usual care

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.

Group Type: EXPERIMENTAL

Physical exercise programme as an add-on

Intervention Type: 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

Usual care

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.

Group Type: PLACEBO_COMPARATOR

Control patients receiving usual care

Intervention Type: OTHER

No exercise intervention

Interventions

Physical exercise programme as an add-on

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

Control patients receiving usual care

No exercise intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Henrik Bo Wiberg Larsson

Consultant, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henrik BW Larsson, Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Health and Medical Science, University of Copenhagen, Denmark

Locations

University College Copenhagen

Copenhagen, Region of Greater Copenhagen, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Henrik BW Larsson, Professor

Role: CONTACT

henrik.bo.wiberg.larsson@regionh.dk

(+45) 24824294

Mette K Zebis, PhD

Role: CONTACT

mzeb@kp.dk

(+45) 30291943

Facility Contacts

Mette K Zebis, Affiliate Professor

Role: primary

mzeb@kp.dk

+45 51632437

Henrik BW Larsson, Professor

Role: backup

henrik.bo.wiberg.larsson@regionh.dk

+45 38632432

Other Identifiers

Repcon123

Identifier Type: -

Identifier Source: org_study_id