RecruitingNot ApplicableNCT06015451

Exercise in Postconcussion Symptoms and Posttraumatic Headache

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


Sponsor

St. Olavs Hospital

Enrollment

100 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

OTHERSub-symptom threshold exercise

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


Locations(1)

St. Olavs Hospital, Clinic of Rehabilitation

Trondheim, Norway

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NCT06015451


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