About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Other diseases blurring the diagnose PCS

Other serious brain diseases

Severe cardiovascular diseases precluding physical activity according to protocol

Trial design

Design model

Parallel

Treatments tested in this trial

Physical exercise programme as an add-on
Other intervention
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 care
Other intervention
No exercise intervention

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Aerobe graded physical exercise intervention and usual careExperimental treatment 1 intervention

Group B: Usual carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame

Change in Buffalo Concussion Bike Test at week 12

Secondary outcomes

1

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

Time frame

Change in point score at week 12

2

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

Time frame

Change in point score at week 12

3

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

Time frame

Change in Buffalo Concussion Bike Test at week 4

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

Time frame

Change in Buffalo Concussion Bike Test at week 8

Rehabilitation in Post Concussion Syndrome

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts