An interventional study of Sub-symptom threshold exercise in Brain Concussion, Post-Concussion Syndrome and Post-Traumatic Headache, sponsored by St. Olavs Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare two models of delivery of guided exercise in patients with exercise intolerance after mild head injury.
The main question it aims to answer is:
Participants will undergo a treadmill test to determine eligibility for the study, and to determine at what intensity level their symptoms worsen (symptom threshold). Thereafter they will exercise 15-20 minutes, 3-5 times per week at 80-90% of the heart rate that was found to be the symptom threshold. One group will receive face-to-face folllow-up and repeated testing, one group will receive telephone-based follow-up only .
Researchers will compare these two groups to see if closer follow-up is superior when it comes to recovery from exercise intolerance after 12 weeks of exercise.
Patients with self-reported symptom exacerbation in relation to physical activity will be screened for inclusion with Buffalo Concussion Treadmill test (BCTT), an incremental treadmill exercise test according to a standard Balke protocol, to the first sign of symptom exacerbation or submaximal exertion. Heart rate and perceived exertion (Borg scale) are measured every minute. Patients who demonstrate symptom exacerbation according to predefined criteria will receive an individually tailored program for workouts with self-selected aerobic activites, of 15-20 minutes duration, 4-5 times per week at 85-90% (measured with HR monitor) of the HR at test termination, and they are randomised to either:
A. Every week the first three weeks, participants will exercise one individual session at the hospital, and the BCTT will be performed every 3rd week at the hospital to be able to shape the intervention.
B. The participants will only exercise at home, and will be contacted by telephone/video call, every week during the first three weeks, thereafter less often, up to every third week.
After 12 weeks, there will be a repeated BCTT, performed by a blinded assessor.
Patient reported outcomes are collected using electronic questionnaires before and after the intervention and 6 months after inclusion.
141 studies on the registry are indexed under Post-Concussion Syndrome; 34 are open to participants now.
This study's planned enrollment of 100 is above the median of 52 across 114 interventional studies indexed under Post-Concussion Syndrome.
Browse Post-Concussion Syndrome studies →St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
Compared within Post-Concussion Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Concussion. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Home-based and in-house exercise, supervised both by telephone and face-to-face. Every week the first three weeks participants will exercise one session at the hospital, and the BCTT/BCCT will be performed every 3rd week, at the hospital in order to be able to shape the intervention.
Other: Sub-symptom threshold exercise
Home-based exercise only, supervised by telephone. The participants will exercise solely in the home setting and will be contacted by telephone, every week during the first three weeks, thereafter every third week. Based on the therapist's evaluation during these calls, the intervention is shaped.
Other: Sub-symptom threshold exercise
Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.
Exercise tolerance
Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)
Time frame: 3 months
Headache burden
Change in days of headache of at least moderate intensity
Time frame: 6 months
Change on self-selected area of function.
Change on the Patient-specific Function Scale (PSFS), the first 3 items, range 0-30, highest is worst.
Time frame: 6 months
Self-reported amount of physical activity
Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.
Time frame: 6 months
Quality of life after head injury (QOL)
Change on the Quality of life after brain injury - Overall Scale (QOLIBRI - OS). Six items rated on an ordinal scale, higher score indicate better QOL.
Time frame: 6 months
Depressive symptoms
Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.
Time frame: 6 months
Anxiety
Change on the Generalized Anxiety Disorder Scale (GAD-7). Seven items range 0-3, higher score indicates more severe symptoms of anxiety.
Time frame: 6 months
Impact of headaches
Change on the Headache Impact Test (HIT)-6. Six items, Total score ranges from 36-78, higher score indicates higher impact.
Time frame: 6 months
Fatigue
Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.
Time frame: 6 months
Adherence to training
The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Started Nov 2022 (actual). Primary completion is estimated for Sep 2027, 58 months after the start.
Of 54 non-industry interventional studies with no phase under Post-Concussion Syndrome, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's planned 58 months is above that.
Counting every sponsor, half of 56 studies reached it within 40 months; a quarter within 23 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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