Actively Recruiting
Rehabilitation of Adult Patients With Post Concussion Syndrome Using Individually Tailored Aerobic Exercise Program
Led by Rigshospitalet, Denmark · Updated on 2026-01-22
70
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
U
University College Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a personalized exercise program for adults with Post-Concussion Syndrome (PCS), a condition involving long-lasting symptoms after a mild traumatic brain injury. The study explores PCS through patient experiences, a physical exercise intervention, neurobiological changes via MRI, and a comprehensive evaluation involving patients and scientists. It aims to better understand symptom patterns, physical capacity improvements, and brain changes related to PCS. The study has two groups: one receiving usual care plus a 12-week individually tailored aerobic exercise program guided by symptoms and pulse rate, performed twice weekly with physiotherapist supervision; the other group continues with usual care alone without added exercise. The exercise involves progressively increasing bike training intensity below symptom provocation thresholds. Usual care follows public healthcare standards. The study also includes qualitative interviews and MRI scans to assess brain function and structure. Participants will undergo clinical assessments before, during, and after the 12-week intervention, including the Buffalo Concussion Bike Test, symptom questionnaires, and weekly wellbeing tracking via SMS. MRI scans will measure blood-brain barrier permeability, brain metabolism, and microstructural changes. A final joint evaluation with patients and researchers will reflect on the project’s strengths and weaknesses. The total participation lasts at least 12 weeks, with multiple scheduled clinical and imaging evaluations.
CONDITIONS
Brief Title
Rehabilitation in Post Concussion Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of Post-Concussion Syndrome according to WHO ICD-10 classification confirmed by a physician
- Have symptoms lasting at least 4 weeks after the initial mild traumatic brain injury
- Be able to prioritize and participate in the exercise program if assigned
- Be able to communicate in Danish
- Be between 18 and 70 years old
You will not qualify if you...
- Have other diseases that confuse the diagnosis of Post-Concussion Syndrome
- Have serious brain diseases other than PCS
- Have severe cardiovascular diseases that prevent participating in the exercise program
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants are assigned to either an individually tailored aerobic exercise program performed twice weekly for 12 weeks as an add-on to usual care, or to usual care without the exercise program. Clinical status is assessed four times during this period, including two interim assessments.
Twice weekly exercise sessions and 4 clinical assessment visits
Duration - Short period after 12 weeks
Participants and researchers conduct a joint evaluation of the project, describing experiences and reflecting on the intervention after completing the 12-week treatment.
1 joint evaluation session
Trial Site Locations
Total: 1 location
1
University College Copenhagen
Copenhagen, Region of Greater Copenhagen, Denmark, 1799
Actively Recruiting
Research Team
H
Henrik BW Larsson, Professor
M
Mette K Zebis, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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