Exercise in Postconcussion Symptoms and Posttraumatic Headache

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015451
• Other study ID #: 468196
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: August 2023
• Source: St. Olavs Hospital
• Contact: Toril Skandsen, PhD
• Phone: +4792692780
• Email: toril.skandsen[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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: 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Craniocerebral Trauma
• Headache
• Post-Concussion Syndrome
• Post-Traumatic Headache

Intervention

Other:
• Sub-symptom threshold exercise
Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.

Locations

Country	Name	City	State
Norway	St. Olavs Hospital, Clinic of Rehabilitation	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise tolerance	Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)	3 months
Secondary	Headache burden	Change in days of headache of at least moderate intensity	6 months
Secondary	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.	6 months
Secondary	Self-reported amount of physical activity	Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.	6 months
Secondary	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.	6 months
Secondary	Depressive symptoms	Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.	6 months
Secondary	Anxiety	Change on the Generalized Anxiety Disorder Scale (GAD-7). Seven items range 0-3, higher score indicates more severe symptoms of anxiety.	6 months
Secondary	Impact of headaches	Change on the Headache Impact Test (HIT)-6. Six items, Total score ranges from 36-78, higher score indicates higher impact.	6 months
Secondary	Fatigue	Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.	6 months
Secondary	Adherence to training	The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.	6 months