Clinical trial NCT04001192: Exercise in Patients With Post-Concussion Symptoms
Official title: Exercise in Patients With Post-Concussion Symptoms - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniocerebral Trauma
Head Injury, Minor
Postconcussion Syndrome
Posttraumatic Headache
Mild Traumatic Brain Injury
Keywords: exercise
exercise therapy
treadmill
symptom threshold
Postconcussion symptoms
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2019-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The proportion of participants completing the exercise program
timeFrame: 12 weeks
measure: Estimated change in post concussion symptom burden
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in posttraumatic headache
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Bjørn Skogstad, md
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital
name: Toril Skandsen, md phd
role: PRINCIPAL_INVESTIGATOR
References: