Exercise in Postconcussion Symptoms and Posttraumatic Headache

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

Tracking Information

• First Submitted Date: July 20, 2023
• First Posted Date: August 29, 2023
• Last Update Posted Date: August 29, 2023
• Actual Study Start Date: November 1, 2022
• Estimated Primary Completion Date: March 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 24, 2023)

Exercise tolerance [ Time Frame: 3 months ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 24, 2023)

• Headache burden [ Time Frame: 6 months ]
  Change in days of headache of at least moderate intensity
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exercise in Postconcussion Symptoms and Posttraumatic Headache
• Official Title: Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache. A Randomized Controlled Trial.

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.

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

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

Intervention

Other: Sub-symptom threshold exercise

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

Study Arms

• 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.

  Intervention: Other: Sub-symptom threshold exercise
• 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.
  Intervention: Other: Sub-symptom threshold exercise

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 24, 2023): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2025
• Estimated Primary Completion Date: March 1, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Toril Skandsen, PhD; +4792692780; toril.skandsen@ntnu.no

Contact: Janne-Birgitte BB Børke, MSc; janne.borke@stolav.no

• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT06015451
• Other Study ID Numbers: 468196
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: St. Olavs Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: St. Olavs Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Britt-Elin Lurud, MD; Clinic of Rehabilitation, St. Olavs Hospital

• PRS Account: St. Olavs Hospital
• Verification Date: August 2023