NCT06177509 Effect of Graded Aerobic Exercise in Mild Traumatic Brain Injury
| NCT ID | NCT06177509 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnaas Rehabilitation Hospital |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2025-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
There is a paucity of knowledge about mechanisms behind mild traumatic brain injury (mTBI) subgroup's sustained problems, and effective interventions that can alleviate this disabling condition. Persistent Post-concussive Symptoms (PCS) affect between 20% and 30% of individuals after mTBI. This Randomized Controlled Trial (RCT) will investigate whether graded aerobic exercise has a positive effect on symptom burden (including exercise intolerance) and Autonomic Nervous System (ANS) dysfunction in patients with PCS. This study will expand upon previous work on adolescents with sport-related concussion in the acute phase. It will cover a wider age group and will include patients with persisting symptoms, thus providing knowledge on whether a sub-symptom threshold aerobic exercise program will alleviate symptom burden in adult patients with PCS. Furthermore - looking into the relationship between mTBI and ANS function, this study is expected to contribute to a better understanding of the neurobiological factors involved in PCS. The results may also help developing targeted interventions to specific characteristics in persistent symptoms after mTBI.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of mild TBI as defined by the World Health Organization (WHO) * Diagnosis of PCS based on ICD-10 criteria for a minimum of 3 months to a maximum of 2 years * Age 18-60 years. * Reduced tolerance to physical activity/exercise intolerance (self-reported worsening of symptoms such as dizziness, nausea or headache during physical activity and exercise). Or have not yet tried physical activity/exercise after the injury. Exclusion Criteria: * Other neurological or severe psychiatric conditions listed in the medical record. * Heart-lung disease. * Extremity injuries that prevent physical exercise * Drug addiction * Insufficient understanding of the Norwegian language (unable to follow instructions and/or fill in forms). * Normal BCTT.