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NCT Number: NCT06015451

Exercise in Postconcussion Symptoms and Posttraumatic Headache

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 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.

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Key information

Conditions

Brain Concussion Behavior Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Headache Disorders Headache Disorders, Secondary Motor Activity Nervous System Diseases Post-Concussion Syndrome Post-Traumatic Headache Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Sub-symptom threshold exercise

Other

Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.

Primary outcomes

  1. Exercise tolerance

    Time frame: 3 months

    Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)

Secondary outcomes

  1. Headache burden

    Time frame: 6 months

    Change in days of headache of at least moderate intensity

  2. Change on self-selected area of function.

    Time frame: 6 months

    Change on the Patient-specific Function Scale (PSFS), the first 3 items, range 0-30, highest is worst.

  3. Self-reported amount of physical activity

    Time frame: 6 months

    Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.

  4. Quality of life after head injury (QOL)

    Time frame: 6 months

    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.

  5. Depressive symptoms

    Time frame: 6 months

    Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.

  6. Anxiety

    Time frame: 6 months

    Change on the Generalized Anxiety Disorder Scale (GAD-7). Seven items range 0-3, higher score indicates more severe symptoms of anxiety.

  7. Impact of headaches

    Time frame: 6 months

    Change on the Headache Impact Test (HIT)-6. Six items, Total score ranges from 36-78, higher score indicates higher impact.

  8. Fatigue

    Time frame: 6 months

    Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.

  9. Adherence to training

    Time frame: 6 months

    The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.

Study contacts

Contact information is provided by the study sponsor or research team.

Janne-Birgitte BB Børke, MSc

CONTACT

[email protected]

Toril Skandsen, PhD

CONTACT

[email protected]

+4792692780

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache. A Randomized Controlled Trial.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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