Brain ConcussionNCT06015451
Exercise in Postconcussion Symptoms and Posttraumatic Headache
A study testing Sub-symptom threshold exercise in people with Brain Concussion and Post-Concussion Syndrome, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
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: Is a program that includes elements of in-house exercise and follow-up sessions, and repeated treadmill testing, superior to a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Concussion, Post-Concussion Syndrome, Post-Traumatic Headache
- What is being tested?
- Sub-symptom threshold exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2022to 1 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Having sustained a minimal head injury or mild traumatic brain injury at least 2 weeks ago.
- At least one postconcussion symptoms, of at least moderate degree, occurring within the first week after the head injury.
- Intolerance for physical activity (self-reported and measured; including symptom exacerbation later on the test day).
- Capable of giving informed consent.
Who cannot join
- More than 2 years since last injury.
- The symptoms are better explained by other conditions.
- Severe communication problems, typically due to poor knowledge of Norwegian.
- Severe psychiatric, neurological, somatic, or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment.
- Safety concerns according to the study medical checklist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janne-Birgitte BB Børke, MSc contact
Norway1 site, 1 recruiting
- Recruiting
St. Olavs Hospital, Clinic of Rehabilitation
Trondheim, 7050
Toril Skandsen, PhD, +47 92692780, toril.skandsen@ntnu.no
Janne-Birgitte BB Børke, Msc, janne.borke@stolav.no
About this study
Official title: Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache. A Randomized Controlled Trial.
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:
Read more
- Is a program that includes elements of in-house exercise and follow-up sessions, and repeated treadmill testing, superior to a program with telephone-based follow-up only?
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.
Read the detailed description
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:
- 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.
- 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.
- Conditions
- Brain Concussion, Post-Concussion Syndrome, Post-Traumatic Headache, Craniocerebral Trauma
- Being tested
- Sub-symptom threshold exercise
- Keywords
- exercise intolerance, exercise, Thread mill test
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Post-Traumatic Headache, Craniocerebral Trauma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-symptom threshold exerciseOther
Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up face-to face | Active comparator | 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. Receives: Other: Sub-symptom threshold exercise |
| Follow-up over the phone | Active comparator | 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. Receives: Other: Sub-symptom threshold exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)
Measured: 3 months
Secondary outcomes (9)
Headache burden
Change in days of headache of at least moderate intensity
Measured: 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.
Measured: 6 months
Self-reported amount of physical activity
Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.
Measured: 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.
Measured: 6 months
Depressive symptoms
Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.
Measured: 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.
Measured: 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.
Measured: 6 months
Fatigue
Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.
Measured: 6 months
Adherence to training
The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Nov 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Britt-Elin Lurud, MD, Study director, Clinic of Rehabilitation, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015451
- Sponsor's protocol ID
- 468196
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No