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Clinical Trials in Denmark / NCT05785000
Recruiting Not applicable

Rehabilitation in Post Concussion Syndrome

NCT05785000 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2023-02-01
Last updated
2026-01-22

Condition(s) studied

Post-Concussion Syndrome

Investigational drug(s) / intervention(s)

Physical exercise programme as an add-onControl patients receiving usual care

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

Control patients receiving usual care: No exercise intervention

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in Buffalo Concussion Bike Test from baseline measurement to week 12 — 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

Trial sites (1)

FacilityCityRegionStatus
University College Copenhagen Copenhagen Region of Greater Copenhagen Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05785000 on ClinicalTrials.gov ↗ ← All trials in Denmark