Exercise in Patients With Post-Concussion Symptoms

Not Applicable

Completed

• Conditions: Craniocerebral Trauma; Postconcussion Syndrome; Head Injury, Minor; Posttraumatic Headache; Mild Traumatic Brain Injury
• Interventions: Behavioral: aerobic exercise program

• Registration Number: NCT04001192
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
exercise	aerobic exercise program	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.

Primary Outcome Measures

Name	Time	Method
The proportion of participants completing the exercise program	12 weeks
Estimated change in post concussion symptom burden	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..

Secondary Outcome Measures

Name	Time	Method
Change in posttraumatic headache	12 weeks	Change in number of days with moderate or severe headache during the last 2 weeks

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway