search
Back to results

Exercise in Postconcussion Symptoms and Posttraumatic Headache

Primary Purpose

Brain Concussion, Post-Concussion Syndrome, Post-Traumatic Headache

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Sub-symptom threshold exercise
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion focused on measuring exercise intolerance, exercise, Thread mill test

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • St. Olavs Hospital, Clinic of RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Follow-up face-to face

Follow-up over the phone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Headache burden
Change in days of headache of at least moderate intensity
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.
Self-reported amount of physical activity
Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.
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.
Depressive symptoms
Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.
Anxiety
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
Change on the Headache Impact Test (HIT)-6. Six items, Total score ranges from 36-78, higher score indicates higher impact.
Fatigue
Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.
Adherence to training
The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.

Full Information

First Posted
July 20, 2023
Last Updated
August 24, 2023
Sponsor
St. Olavs Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06015451
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Post-Concussion Syndrome, Post-Traumatic Headache, Craniocerebral Trauma
Keywords
exercise intolerance, exercise, Thread mill test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The treadmill test after completion of intervention is performed by an assessor that is blinded for group membership.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Follow-up face-to face
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Follow-up over the phone
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Sub-symptom threshold exercise
Intervention Description
Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.
Primary Outcome Measure Information:
Title
Exercise tolerance
Description
Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Headache burden
Description
Change in days of headache of at least moderate intensity
Time Frame
6 months
Title
Change on self-selected area of function.
Description
Change on the Patient-specific Function Scale (PSFS), the first 3 items, range 0-30, highest is worst.
Time Frame
6 months
Title
Self-reported amount of physical activity
Description
Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.
Time Frame
6 months
Title
Quality of life after head injury (QOL)
Description
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
Title
Depressive symptoms
Description
Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.
Time Frame
6 months
Title
Anxiety
Description
Change on the Generalized Anxiety Disorder Scale (GAD-7). Seven items range 0-3, higher score indicates more severe symptoms of anxiety.
Time Frame
6 months
Title
Impact of headaches
Description
Change on the Headache Impact Test (HIT)-6. Six items, Total score ranges from 36-78, higher score indicates higher impact.
Time Frame
6 months
Title
Fatigue
Description
Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.
Time Frame
6 months
Title
Adherence to training
Description
The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toril Skandsen, PhD
Phone
+4792692780
Email
toril.skandsen@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Janne-Birgitte BB Børke, MSc
Email
janne.borke@stolav.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britt-Elin Lurud, MD
Organizational Affiliation
Clinic of Rehabilitation, St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St. Olavs Hospital, Clinic of Rehabilitation
City
Trondheim
ZIP/Postal Code
7050
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toril Skandsen, PhD
Phone
+47 92692780
Email
toril.skandsen@ntnu.no
First Name & Middle Initial & Last Name & Degree
Janne-Birgitte BB Børke, Msc
Email
janne.borke@stolav.no

12. IPD Sharing Statement

Learn more about this trial

Exercise in Postconcussion Symptoms and Posttraumatic Headache

We'll reach out to this number within 24 hrs