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NCT Number: NCT04001192

Exercise in Patients With Post-Concussion Symptoms

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.

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Key information

Conditions

Craniocerebral Trauma Behavior Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Head Injuries, Closed Head Injury, Minor Headache Disorders Headache Disorders, Secondary Mild Traumatic Brain Injury Motor Activity Nervous System Diseases Post-Concussion Syndrome Post-Traumatic Headache Postconcussion Syndrome Posttraumatic Headache Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The proportion of participants completing the exercise program

    Time frame: 12 weeks

  2. Estimated change in post concussion symptom burden

    Time frame: 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 outcomes

  1. Change in posttraumatic headache

    Time frame: 12 weeks

    Change in number of days with moderate or severe headache during the last 2 weeks

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 27, 2019
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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