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Exercise in Postconcussion Symptoms and Posttraumatic Headache

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ClinicalTrials.gov Identifier: NCT06015451
Recruitment Status : Recruiting
First Posted : August 29, 2023
Last Update Posted : August 29, 2023
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital

Study Description
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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 Not Applicable

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:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2022
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: 3 months ]
    Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06015451


Contacts
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Contact: Toril Skandsen, PhD +4792692780 toril.skandsen@ntnu.no
Contact: Janne-Birgitte BB Børke, MSc janne.borke@stolav.no

Locations
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Norway
St. Olavs Hospital, Clinic of Rehabilitation Recruiting
Trondheim, Norway, 7050
Contact: Toril Skandsen, PhD    +47 92692780    toril.skandsen@ntnu.no   
Contact: Janne-Birgitte BB Børke, Msc       janne.borke@stolav.no   
Sponsors and Collaborators
St. Olavs Hospital
Investigators
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Study Director: Britt-Elin Lurud, MD Clinic of Rehabilitation, St. Olavs Hospital
  Study Documents (Full-Text)

Documents provided by St. Olavs Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] October 10, 2022

More Information
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT06015451    
Other Study ID Numbers: 468196
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
exercise intolerance
exercise
Thread mill test
Additional relevant MeSH terms:
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Post-Concussion Syndrome
Post-Traumatic Headache
Brain Concussion
Craniocerebral Trauma
Headache
Pain
Neurologic Manifestations
Head Injuries, Closed
Trauma, Nervous System
 Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Brain Injuries, Traumatic
Brain Injuries