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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2023-11-17 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Marianne Løvstad, Professor
PRINCIPAL INVESTIGATOR
Head of psychology
Frequently Asked Questions
Who can join the NCT06177509 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06177509 currently recruiting?
Yes, NCT06177509 is actively recruiting participants. Contact the research team at mar.lovstad@gmail.com for enrollment information.
Where is the NCT06177509 trial being conducted?
This trial is being conducted at Nesoddtangen, Norway, Oslo, Norway.
Who is sponsoring the NCT06177509 clinical trial?
NCT06177509 is sponsored by Sunnaas Rehabilitation Hospital. The principal investigator is Marianne Løvstad, Professor at Head of psychology. The trial plans to enroll 72 participants.