Exercise in Patients With Post-Concussion Symptoms

NCT04001192 | Completed

• 1 other identifier: 2018/2159
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

exercise; exercise therapy; treadmill; symptom threshold; Postconcussion symptoms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in posttraumatic headache

  12 weeks

Study Arms (1)

exercise

EXPERIMENTAL

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

Interventions

aerobic exercise program BEHAVIORAL

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.

exercise

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Post-Concussion Syndrome; Post-Traumatic Headache; Brain Concussion; Motor Activity

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Brain Injuries, Traumatic; Brain Injuries; Behavior

Study Officials

• Bjørn Skogstad, md

  St. Olavs Hospital

  STUDY DIRECTOR

• Toril Skandsen, md phd

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 27, 2019
• Study Start: February 14, 2019
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)