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Exercise in Patients With Post-Concussion Symptoms

Exercise in Patients With Post-Concussion Symptoms - a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04001192
Enrollment
30
Registered
2019-06-27
Start date
2019-02-14
Completion date
2021-07-08
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniocerebral Trauma, Head Injury, Minor, Postconcussion Syndrome, Posttraumatic Headache, Mild Traumatic Brain Injury

Keywords

exercise, exercise therapy, treadmill, symptom threshold, Postconcussion symptoms

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.

Interventions

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.

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The proportion of participants completing the exercise program12 weeks
Estimated change in post concussion symptom burden12 weeksassessed 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..

Secondary

MeasureTime frameDescription
Change in posttraumatic headache12 weeksChange in number of days with moderate or severe headache during the last 2 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026