Actively Recruiting
Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache A Randomized Controlled Trial
Led by St. Olavs Hospital · Updated on 2025-07-08
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating exercise programs for people who have trouble exercising after a mild head injury or concussion. The study compares two ways of guiding exercise: one includes in-person sessions with treadmill testing and face-to-face follow-up, while the other uses telephone-based follow-up only. The goal is to find out which approach helps recovery better after 12 weeks of exercise. Participants will first take a treadmill test to find the exercise intensity that causes symptom worsening. Then, they will do aerobic exercise at 85-90% of that heart rate for 15-20 minutes, 4-5 times a week. One group will have weekly in-person exercise sessions at the hospital during the first three weeks and treadmill tests every three weeks, while the other group will exercise at home with telephone or video call support weekly at first, then less often. During the study, participants complete electronic questionnaires before, after, and 6 months after the exercise program. Researchers will measure exercise tolerance after 3 months and assess symptoms like headache, quality of life, depression, anxiety, fatigue, and adherence to training up to 6 months. The study involves ongoing monitoring and comparison of recovery between the two groups over time.
CONDITIONS
Brief Title
Exercise in Postconcussion Symptoms and Posttraumatic Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- Mild head injury or concussion sustained at least 2 weeks ago
- At least one moderate or worse postconcussion symptom starting within the first week after injury
- Self-reported intolerance to physical activity, confirmed by symptom worsening on treadmill test
- Able to provide informed consent
You will not qualify if you...
- More than 2 years since last head injury
- Symptoms explained better by other medical conditions
- Severe communication difficulties, such as poor Norwegian language skills
- Severe psychiatric, neurological, physical illness, or substance abuse that may interfere with group participation or follow-up
- Safety concerns identified by medical checklist
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) for Buffalo Concussion Treadmill Test
Duration - 12 weeks
Participants receive a tailored aerobic exercise program at an intensity just below the symptom exacerbation threshold. They are randomized to either supervised exercise sessions at the hospital or home-based exercise with telephone supervision.
Weekly in-person exercise sessions for the first 3 weeks with treadmill test every 3rd week for one group; weekly telephone/video calls for the first 3 weeks then every third week for the other group
Duration - Up to 6 months after inclusion
Participants complete a repeated treadmill test by a blinded assessor and provide patient-reported outcomes through electronic questionnaires up to 6 months after inclusion.
Electronic questionnaires before and after intervention and at 6 months; 1 in-person treadmill test at 3 months
Trial Site Locations
Total: 1 location
1
St. Olavs Hospital, Clinic of Rehabilitation
Trondheim, Norway, 7050
Actively Recruiting
Research Team
T
Toril Skandsen, PhD
J
Janne-Birgitte BB Børke, MSc
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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