Exercise in Patients With Post-Concussion Symptoms

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001192
• Other study ID #: 2018/2159
• Status: Completed
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: July 8, 2021

Study information

• Verified date: March 2022
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Head Injury, Minor
• Headache
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome
• Post-Traumatic Headache
• Postconcussion Syndrome
• Posttraumatic Headache
• Wounds and Injuries

Intervention

Behavioral:
• aerobic exercise program
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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants completing the exercise program		12 weeks
Primary	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..	12 weeks
Secondary	Change in posttraumatic headache	Change in number of days with moderate or severe headache during the last 2 weeks	12 weeks