Exercise in Postconcussion Symptoms and Posttraumatic Headache

Sponsor

St. Olavs Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06015451

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain Concussion Post-Concussion Syndrome Post-Traumatic Headache Craniocerebral Trauma	Other: Sub-symptom threshold exercise	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The treadmill test after completion of intervention is performed by an assessor that is blinded for group membership.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Follow-up face-to face 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.	Other: Sub-symptom threshold exercise Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.
Active Comparator: Follow-up over the phone 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.	Other: Sub-symptom threshold exercise Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.

Arm

Intervention/Treatment

Active Comparator: Follow-up face-to face

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.

Other: Sub-symptom threshold exercise

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

Active Comparator: Follow-up over the phone

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.

Other: Sub-symptom threshold exercise

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

Outcome Measures

Primary Outcome Measures

Exercise tolerance [3 months]
Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)

Secondary Outcome Measures

Headache burden [6 months]
Change in days of headache of at least moderate intensity
Change on self-selected area of function. [6 months]
Change on the Patient-specific Function Scale (PSFS), the first 3 items, range 0-30, highest is worst.
Self-reported amount of physical activity [6 months]
Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.
Quality of life after head injury (QOL) [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.
Depressive symptoms [6 months]
Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.
Anxiety [6 months]
Change on the Generalized Anxiety Disorder Scale (GAD-7). Seven items range 0-3, higher score indicates more severe symptoms of anxiety.
Impact of headaches [6 months]
Change on the Headache Impact Test (HIT)-6. Six items, Total score ranges from 36-78, higher score indicates higher impact.
Fatigue [6 months]
Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.
Adherence to training [6 months]
The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.