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Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury

Primary Purpose

Mild Traumatic Brain Injury

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

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Mild Traumatic Brain Injury, Buffalo Concussion Treadmill Test, Sub-symptom aerobic exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with mild TBI defined by the World Health Organization (WHO) Collaborating Center Task Force definition: 1) one or more of the following: confusion or disorientation, loss of consciousness (LOC) ≤30 minutes, post-traumatic memory loss (PTA) ≤24 hours and / or transient neurological focal deficits and intracranial lesions that do not require surgery; 2) Glasgow Coma Scale (GCS) score of 13-15 at least 30 minutes after trauma).
  • 18-60 years with persistent post-commotio symptoms (minimum 3 months maximum 2 years).
  • Reduced tolerance to physical activity/exercise intolerance (self-reported worsening of symptoms such as dizziness and headache during physical activity and exercise).

Exclusion Criteria:

  • Other neurological or psychiatric conditions (not including anxiety and depression) listed in the medical record. Heart-lung disease, extremity injuries that prevent physical exercise, drug addiction and insufficient understanding of the Norwegian language (unable to follow instructions and/or fill in forms). Normal BCTT.

Sites / Locations

  • Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Treatment as usual group

Arm Description

The exercise group will in addition to treatment as usual, receive sub-symptom threshold aerobic exercise for approx. 30 minutes 3-5x / week for 12 weeks. Sub-symptom threshold aerobic exercise is based on the individual patient's symptom threshold and will be between 80-90% of the maximum heart rate achieved during testing/BCTT. To ensure proper exercise dosage and progression, participants will be retested every 3 weeks. An experienced doctor and / or physiotherapist will carry out the testing and guide the participants in the content and dosage (duration, intensity, and frequency) of the sub-symptom threshold aerobic exercise/intervention.

The treatment as usual group will receive assessment and treatment provided by a multidisciplinary outpatient rehabilitation team. Patients will undergo a medical examination and assessment of physical, cognitive and mental health and functioning, followed by individually adapted rehabilitation. The interdisciplinary team consists of a specialist in physical medicine and rehabilitation, neuropsychologist, occupational therapist, physiotherapist, and social worker. The main focus is on stabilizing the level of function in everyday life and gradual return to work and education. Participants receive general advice on physical activity based on recommendations from the Norwegian Directorate of Health, but not specific guidance in sub-symptom threshold aerobic exercise and help with exercise dosage (frequency, duration and intensity).

Outcomes

Primary Outcome Measures

Change on the Rivermead Post Concussion Symptoms Questionnaire - RPQ
A 16-item standardized and validated questionnaire designed to measure the severity of post-concussion symptoms following TBI. The five-point ordinal scale ranges from 0 (no problem) to 4 (severe problem). The total score ranges from 0-64, with higher scores indicating a higher symptom load. RPQ has satisfactory psychometric properties and is a widely used in TBI and persistent post-commotio symptoms research. The minimum clinically important difference (MCID) is 4.6 points.

Secondary Outcome Measures

Change on the Buffalo Concussion Treadmill Test - BCTT
Buffalo Concussion Treadmill Test (BCTT) is a standardized test of exercise tolerance developed for patients with mild TBI/concussion. Exercise tolerance is tested by gradually increasing the load while walking on a treadmill. The test protocol starts with a speed set at 6.8 km/h at 0% incline for the first minute. The speed will be maintained but the incline will be increased by 1% every minute thereafter. Every minute, symptoms (NRS scale), ratings of perceived exertion (Borg RPE), HR and blood pressure are registered. The test is stopped by symptom exacerbation defined as an increase of ≥ 3 points on a 0-10 (best-worst) point NRS scale or at the point of voluntary exhaustion (Borg RPE scale ≥17). If the maximum incline of 15% is reached, the speed will be in increased by 0,5 km/h each subsequent minute until the stop criteria described over is reached. The test will not be performed if the patients report symptoms ≥ 7 on the NRS scale.

Full Information

First Posted
October 5, 2021
Last Updated
December 14, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05086419
Brief Title
Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury
Official Title
Sub-symptom Threshold Aerobic Exercise Training for Patients With Exercise Intolerance and Persistent Symptoms After Mild Traumatic Brain Injury - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
August 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

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

5. Study Description

Brief Summary
This Randomized Controlled Trial (RCT) will explore the effect of sub-symptom threshold aerobic exercise on persistent post-concussion symptoms and exercise intolerance in patients with mild Traumatic Brain Injury (TBI). The hypothesis is that sub-symptom training will reduce the symptom pressure, normalize exercise tolerance, reduce patient-specific activity limitations and improve health-related quality of life. To improve the chances of conducting a high-quality RCT, a feasibility trial will be completed prior to the definitive RCT.
Detailed Description
Background: Persistent post-commotio symptoms (PCS) affect between 34% and 46% of individuals after a mild traumatic brain injury (TBI). Many also experience exercise intolerance. Sub-symptom threshold aerobic exercise (exercise at an intensity level that does not increase symptoms) is proposed as treatment both to increase the exercise tolerance and to ease the symptom burden after the injury. Main purpose: The main purpose of this study is to evaluate whether a progressive sub-symptom threshold exercise program in addition to ordinary rehabilitation will lead to clinically meaningful improvement of symptom burden, normalize exercise tolerance, increase physical activity, improve health-related quality of life, and reduce patient-specific activity limitations compared to a control group that only receives ordinary rehabilitation. Design: Randomized, controlled, single-blind parallel-group study with three measurement times; T0 at baseline, T1 after the intervention and T2 six months after T1. Method: 68 patients between the ages of 18 and 60 with exercise intolerance and persistent PCS will be recruited to the study and randomized to two groups. All participants will receive ordinary rehabilitation. The intervention group will in addition receive sub-symptom threshold aerobic exercise for 12 weeks with weekly follow-up by a physiotherapist and a retest every 3 weeks for optimal dosage and progression. Rivermead post-concussion symptoms questionnaire (RPQ) will be the main outcome measure. The secondary outcome measure will be a test of exercise tolerance - the Buffalo Concussion Treadmill Test (BCTT). Other outcome measures include the patient-specific functional scale that measures patient-specific activity limitations, as well as outcome measures for health-related quality of life, anxiety and depression, specific symptoms such as dizziness, headache and fatigue, and level of physical activity. Clinical relevance: Since people with persistent symptoms after mild TBI often have reduced level of functioning and difficulty working / studying full time, there is a great need for an individually tailored intervention that has the potential to reduce persistent symptoms and improve functioning This project will increase the evidence based knowledge about the effect of sub-symptom threshold aerobic exercise in patient with persistent symptoms after mild TBI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Mild Traumatic Brain Injury, Buffalo Concussion Treadmill Test, Sub-symptom aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, single-blind parallel group design.
Masking
Outcomes Assessor
Masking Description
After written informed consent, patients will be randomized to the intervention or control group using computer-generated lists. Block randomization with variable block size that is unknown to the research group will be used. Follow-up tests at T1 and T2 will be performed by a research assistant who is blind to the group distribution and who is not involved in any parts of the intervention. Statisticians will be blinded to group allocation.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
The exercise group will in addition to treatment as usual, receive sub-symptom threshold aerobic exercise for approx. 30 minutes 3-5x / week for 12 weeks. Sub-symptom threshold aerobic exercise is based on the individual patient's symptom threshold and will be between 80-90% of the maximum heart rate achieved during testing/BCTT. To ensure proper exercise dosage and progression, participants will be retested every 3 weeks. An experienced doctor and / or physiotherapist will carry out the testing and guide the participants in the content and dosage (duration, intensity, and frequency) of the sub-symptom threshold aerobic exercise/intervention.
Arm Title
Treatment as usual group
Arm Type
No Intervention
Arm Description
The treatment as usual group will receive assessment and treatment provided by a multidisciplinary outpatient rehabilitation team. Patients will undergo a medical examination and assessment of physical, cognitive and mental health and functioning, followed by individually adapted rehabilitation. The interdisciplinary team consists of a specialist in physical medicine and rehabilitation, neuropsychologist, occupational therapist, physiotherapist, and social worker. The main focus is on stabilizing the level of function in everyday life and gradual return to work and education. Participants receive general advice on physical activity based on recommendations from the Norwegian Directorate of Health, but not specific guidance in sub-symptom threshold aerobic exercise and help with exercise dosage (frequency, duration and intensity).
Intervention Type
Other
Intervention Name(s)
Sub-symptom threshold aerobic exercise
Intervention Description
For the first three weeks, participants will be offered guided sub-symptom threshold aerobic exercise on a treadmill or exercise bike once a week. The remaining 2-4 sub-symptom threshold aerobic exercise workouts per. week will be on their own. Location and mode of exercise (treadmill, walking, jogging, exercise bike / bicycle, swimming, or elliptical machine) will be individually adapted to the patients experience, preferences and opportunities. The intensity of the sub-symptom threshold aerobic exercise will always be monitored using a heart rate monitor and/or ratings of perceived exertion (Borg RPE). If there still is a need for closer follow-up after the first three weeks, a physiotherapist in primary health care service will be involved under supervision from a physiotherapist (research fellow) in the project.
Primary Outcome Measure Information:
Title
Change on the Rivermead Post Concussion Symptoms Questionnaire - RPQ
Description
A 16-item standardized and validated questionnaire designed to measure the severity of post-concussion symptoms following TBI. The five-point ordinal scale ranges from 0 (no problem) to 4 (severe problem). The total score ranges from 0-64, with higher scores indicating a higher symptom load. RPQ has satisfactory psychometric properties and is a widely used in TBI and persistent post-commotio symptoms research. The minimum clinically important difference (MCID) is 4.6 points.
Time Frame
12 weeks and 6 months.
Secondary Outcome Measure Information:
Title
Change on the Buffalo Concussion Treadmill Test - BCTT
Description
Buffalo Concussion Treadmill Test (BCTT) is a standardized test of exercise tolerance developed for patients with mild TBI/concussion. Exercise tolerance is tested by gradually increasing the load while walking on a treadmill. The test protocol starts with a speed set at 6.8 km/h at 0% incline for the first minute. The speed will be maintained but the incline will be increased by 1% every minute thereafter. Every minute, symptoms (NRS scale), ratings of perceived exertion (Borg RPE), HR and blood pressure are registered. The test is stopped by symptom exacerbation defined as an increase of ≥ 3 points on a 0-10 (best-worst) point NRS scale or at the point of voluntary exhaustion (Borg RPE scale ≥17). If the maximum incline of 15% is reached, the speed will be in increased by 0,5 km/h each subsequent minute until the stop criteria described over is reached. The test will not be performed if the patients report symptoms ≥ 7 on the NRS scale.
Time Frame
12 weeks and 6 months.
Other Pre-specified Outcome Measures:
Title
Change on the Patient-specific functional scale (PSFS)
Description
The Patient-specific functional scale (PSFS) is a patient-specific measure whereby the patients identify activities they are unable to perform or have difficulty in performing related to their health condition. The patients were asked to rate the current level of difficulty associated with each activity by using a Numeric Rating Scale (NRS) ranging from 0 (unable to perform the activity) to 10 (able to perform the activity with no difficulty or as before the injury).
Time Frame
12 weeks and 6 months.
Title
Change on the Quality of life after brain injury - Overall Scale (QOLIBRI - OS)
Description
Quality of life after brain injury (QOLIBRI) will be used to examine health-related quality of life (HRQL). The questionnaire consists of 37 questions divided into 6 dimensions of HRQL: Cognition, Self, Daily life and Autonomy, Social relationships, Emotions and Physical problems. Each item is scored on a 5-point scale, from 1 (not-at-all satisfied) to 5 (very satisfied). The total score range of 0 (lowest) to 100 (highest). A score below 60 points has been suggested as poor HRQL. The QOLIBRI is applicable to people with TBI of all severities and at all time points after the injury.
Time Frame
12 weeks and 6 months.
Title
Change on the Patient Health Questionnaire (PHQ-9)
Description
Patient Health Questionnaire (PHQ-9) will be used to examine/assess depressive symptoms. The questionnaire consists of 9 items on a 4 point scale ranging from 0-27 (best-worst). PHQ-9 is validated and often used in people with TBI.
Time Frame
12 weeks and 6 months.
Title
Change on the Generalized Anxiety Disorder Scale (GAD-7)
Description
The Generalized Anxiety Disorder Scale (GAD-7) will be used to examine anxiety. The questionnaire consists of 7 items ranging from 0-21 (best-worst).
Time Frame
12 weeks and 6 months.
Title
Change on the Headache Impact Test (HIT).
Description
The impact of headaches on life will be investigated with the Headache Impact Test (HIT). The questionnaire has 6 questions that address the severity of the headache and the headache's impact on daily activities, psychosocial and cognitive functioning. The six items is scored on a 5 point scale ranging fram never to always (best-worst).
Time Frame
12 weeks and 6 months.
Title
Change on the Fatigue Severity Scale (FSS).
Description
The Fatigue Severity Scale (FSS) consists of 9 questions about the physical and cognitive effects of fatigue. It is scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. The total score ranges from 9 to 63, the higher the score, the more severe fatigue.
Time Frame
12 weeks and 6 months.
Title
Change on the International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaire (IPAQ) is a 7 item questionnaire that will be used to register health-related physical activity. The response can be categorized into three categories: 1 = inactive, 2 = minimally active, 3 = Health Enhancing Physical Activity (HEPA) active.
Time Frame
12 weeks and 6 months.
Title
Change on the Single leg stance test (SLS)
Description
Balance will be measured with the single leg stance test (SLS). SLS tests the balance ability in patients with vestibular conditions and can detect changes over time.
Time Frame
12 weeks and 6 months.
Title
The Problematic Experience of Therapy scale (PETS)
Description
Adherence to training will be measured with the PETS which is a brief quantitative measure developed to reflect the most commonly reported reasons for discontinuing therapy/training given by patients undergoing self-managed home-based rehabilitation/training.
Time Frame
12 weeks and T2 six months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with mild TBI defined by the World Health Organization (WHO) Collaborating Center Task Force definition: 1) one or more of the following: confusion or disorientation, loss of consciousness (LOC) ≤30 minutes, post-traumatic memory loss (PTA) ≤24 hours and / or transient neurological focal deficits and intracranial lesions that do not require surgery; 2) Glasgow Coma Scale (GCS) score of 13-15 at least 30 minutes after trauma). 18-60 years with persistent post-commotio symptoms (minimum 3 months maximum 2 years). Reduced tolerance to physical activity/exercise intolerance (self-reported worsening of symptoms such as dizziness and headache during physical activity and exercise). Exclusion Criteria: Other neurological or psychiatric conditions (not including anxiety and depression) listed in the medical record. Heart-lung disease, extremity injuries that prevent physical exercise, drug addiction and insufficient understanding of the Norwegian language (unable to follow instructions and/or fill in forms). Normal BCTT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars-Johan Viddal Valaas, Msc.
Phone
45204747
Ext
+47
Email
lavala@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ingerid Kleffelgård, Phd
Phone
99010874
Ext
+47
Email
inff@live.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingerid Kleffelgård, Phd
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars-Johan Viddal Valaas, Msc.
Phone
45204747
Email
lavala@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Ingerid Kleffelgård, Phd.
Phone
+4799010874
Email
inff@live.no
First Name & Middle Initial & Last Name & Degree
Helene Lundgaard Søberg, Phd
First Name & Middle Initial & Last Name & Degree
Mari Rasmussen, Phd
First Name & Middle Initial & Last Name & Degree
Nada Andelic, Phd

12. IPD Sharing Statement

Plan to Share IPD
No

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Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury

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