Exercise in Patients With Post-Concussion Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Craniocerebral Trauma; Mild Traumatic Brain Injury; Head Injury, Minor; Posttraumatic Headache; Postconcussion Syndrome
• Intervention / Treatment: Behavioral: aerobic exercise program

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: exercise; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants completing the exercise program		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..	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in posttraumatic headache	Change in number of days with moderate or severe headache during the last 2 weeks	12 weeks

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Study Director: Bjørn Skogstad, md, St. Olavs Hospital; Principal Investigator: Toril Skandsen, md phd, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2019
• Primary Completion (ACTUAL): July 8, 2021
• Study Completion (ACTUAL): July 8, 2021

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (ACTUAL): June 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: exercise; exercise therapy; treadmill; symptom threshold; Postconcussion symptoms
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Trauma, Nervous System; Headache Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Headache Disorders, Secondary; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Headache; Craniocerebral Trauma; Post-Concussion Syndrome; Brain Concussion; Post-Traumatic Headache
• Other Study ID Numbers: 2018/2159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No