Rehabilitation in Post Concussion Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical exercise programme as an add-on, Control patients receiving usual care.
- Who it may be relevant to
- Registry conditions: Post-Concussion Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Rehabilitation of Adult Patients With Post Concussion Syndrome
Overview
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.
Interventions
- Other 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 - Other Control patients receiving usual care
No exercise intervention
Primary outcome measures
- Change in Buffalo Concussion Bike Test from baseline measurement to week 12 [Time frame: Change in Buffalo Concussion Bike Test at week 12]
Secondary outcome measures (12)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- University College Copenhagen — Copenhagen
Identifiers
NCT: NCT05785000 · Repcon123