Craniocerebral TraumaNCT04001192
Exercise in Patients With Post-Concussion Symptoms
A study testing aerobic exercise program in people with Craniocerebral Trauma and Head Injury, Minor, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Physical activity and exercise have traditionally not been much of a focus in treatment of postconcussion symptoms and posttraumatic headache. On the contrary, patients have often got advice to rest until they were free from symptoms. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Craniocerebral Trauma, Head Injury, Minor, Postconcussion Syndrome
- What is being tested?
- aerobic exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 14 Feb 2019to 8 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- having sustained a minimal head injury (according to the Head Injury Severity Scale, HISS) or mild traumatic brain injury (TBI) (according to the TBI definition and the WHO criteria for mild TBI) within the last three years).
- post-concussion symptoms of at least moderate degree (according to the Rivermead postconcussion symptom questionnaire RPCSQ) occurring within the first week after the head injury and/or posttraumatic headache according to the International Classification of Headache Disorders 3 (ICHD-3) criteria.
- outpatients at St Olavs Hospital Clinic of Physical Medicine and Rehabilitation, Department of Acquired Brain Injury
Who cannot join
- Symptoms better explained by other conditions.
- Severe communication problems, typically due to language problems.
- Severe psychiatric, neurological, somatic or substance abuse disorders that will complicate follow-up and outcome assessment.
- Orthopedic injury or other disability too severe for performing the test or the intervention.
- Cardiovascular conditions or risk factors that are not compatible with testing or safe unsupervised exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise in Patients With Post-Concussion Symptoms - a Pilot Study
Physical activity and exercise have traditionally not been much of a focus in treatment of postconcussion symptoms and posttraumatic headache. On the contrary, patients have often got advice to rest until they were free from symptoms. This approach, however, is challenged, and complete rest should probably be discouraged after the first 24-72 hours. Moderate aerobic exercise has been found promising in the early phase after sports-related concussion, and in the treatment of patients with headache. This study is an open pilot-study of guided, home-based exercise in a clinical sample with postconcussion symptoms and posttraumatic headache after mixed-mechanism mild traumatic brain injury and minimal head injuries. The study will result in data about the feasibility and possible effects of exercise as treatment for prolonged postconcussion symptoms and posttraumatic headache.
- Conditions
- Craniocerebral Trauma, Head Injury, Minor, Postconcussion Syndrome, Posttraumatic Headache, Mild Traumatic Brain Injury
- Being tested
- aerobic exercise program
- Keywords
- exercise, exercise therapy, treadmill, symptom threshold, Postconcussion symptoms
- Medical subject headings
- Craniocerebral Trauma, Post-Concussion Syndrome, Post-Traumatic Headache, Brain Concussion, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise programBehavioural
The intervention is exercise at home, 5-6 days per week during 12 weeks, guided by a schedule that the physiotherapist will design after initial treadmill testing. Exercise intensity is 80-90 % of the heart rate threshold that was identified by the treadmill test. During the 12 weeks program, intensity will be increased according to feedback from the participant.
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | exercise at home, 5-6 days per week during 12 weeks, guided by a schedule that the physiotherapist will design after initial treadmill testing. Exercise intensity is 80-90 % of the heart rate threshold that was identified by the treadmill test. During the 12 weeks program, intensity will be increased according to feedback from the participant. Receives: Behavioral: aerobic exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants completing the exercise program
Measured: 12 weeks
Estimated change in post concussion symptom burden
assessed with Rivermead postconcussion symptom questionnaire (www.tbi-impact.org/cde/mod_templates/12_F_06_Rivermead.pdf) 17 questions about severeness of symptoms, answers 0 (not experienced at all) - 4 (a severe problem). Ratings on the total symptom scores, and for individual items..
Measured: 12 weeks
Secondary outcomes (1)
Change in posttraumatic headache
Change in number of days with moderate or severe headache during the last 2 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start14 Feb 2019
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniocerebral TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Bjørn Skogstad, md, Study director, St. Olavs HospitalToril Skandsen, md phd, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001192
- Sponsor's protocol ID
- 2018/2159
- Status last verified
- Mar 2022
- First submitted
- 26 Jun 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Patients With Post-Concussion Symptoms - a Pilot Study
- ClinicalTrials.gov ID
- NCT04001192
- Acronym / sponsor ID
- 2018/2159
- Conditions
- Craniocerebral Trauma, Head Injury, Minor, Postconcussion Syndrome, Posttraumatic Headache, Mild Traumatic Brain Injury
- Keywords
- exercise, exercise therapy, treadmill, symptom threshold, Postconcussion symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity and exercise have traditionally not been much of a focus in treatment of postconcussion symptoms and posttraumatic headache. On the contrary, patients have often got advice to rest until they were free from symptoms. This approach, however, is challenged, and complete rest should probably be discouraged after the first 24-72 hours. Moderate aerobic exercise has been found promising in the early phase after sports-related concussion, and in the treatment of patients with headache. This study is an open pilot-study of guided, home-based exercise in a clinical sample with postconcussion symptoms and posttraumatic headache after mixed-mechanism mild traumatic brain injury and minimal head injuries. The study will result in data about the feasibility and possible effects of exercise as treatment for prolonged postconcussion symptoms and posttraumatic headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: aerobic exercise programexercise at home, 5-6 days per week during 12 weeks, guided by a schedule that the physiotherapist will design after initial treadmill testing. Exercise intensity is 80-90 % of the heart rate threshold that was identified by the treadmill test. During the 12 weeks program, intensity will be increased according to feedback from the participant. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- having sustained a minimal head injury (according to the Head Injury Severity Scale, HISS) or mild traumatic brain injury (TBI) (according to the TBI definition and the WHO criteria for mild TBI) within the last three years).
- post-concussion symptoms of at least moderate degree (according to the Rivermead postconcussion symptom questionnaire RPCSQ) occurring within the first week after the head injury and/or posttraumatic headache according to the International Classification of Headache Disorders 3 (ICHD-3) criteria.
- outpatients at St Olavs Hospital Clinic of Physical Medicine and Rehabilitation, Department of Acquired Brain Injury
Key exclusion criteria (5 listed)
- Symptoms better explained by other conditions.
- Severe communication problems, typically due to language problems.
- Severe psychiatric, neurological, somatic or substance abuse disorders that will complicate follow-up and outcome assessment.
- Orthopedic injury or other disability too severe for performing the test or the intervention.
- Cardiovascular conditions or risk factors that are not compatible with testing or safe unsupervised exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise programThe intervention is exercise at home, 5-6 days per week during 12 weeks, guided by a schedule that the physiotherapist will design after initial treadmill testing. Exercise intensity is 80-90 % of the heart rate threshold that was identified by the treadmill test. During the 12 weeks program, intensity will be increased according to feedback from the participant. | Behavioural | exercise |
Primary outcome
The proportion of participants completing the exercise program
Time frame: 12 weeks
Estimated change in post concussion symptom burden
Time frame: 12 weeks
assessed with Rivermead postconcussion symptom questionnaire (www.tbi-impact.org/cde/mod_templates/12_F_06_Rivermead.pdf) 17 questions about severeness of symptoms, answers 0 (not experienced at all) - 4 (a severe problem). Ratings on the total symptom scores, and for individual items..
1 secondary outcome
Change in posttraumatic headache
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn Skogstad, md study director
St. Olavs Hospital
Toril Skandsen, md phd principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise program in people with Craniocerebral Trauma and Head Injury, Minor, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants completing the exercise program (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.