Health TrialsbyHealthPanel

Exercise in Postconcussion Symptoms and Posttraumatic Headache

ConditionsBrain ConcussionPost-Concussion SyndromePost-Traumatic HeadacheCraniocerebral Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Olavs Hospital

About this 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:

• 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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sub-symptom threshold exercise

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Follow-up face-to faceActive comparator 1 intervention
Group B: Follow-up over the phoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise tolerance

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

Time frame
3 months

Secondary outcomes

1

Headache burden

Change in days of headache of at least moderate intensity

Time frame
6 months
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now