Graded aerobic exercise for mild traumatic brain injury
Effect of Graded Aerobic Exercise in Mild Traumatic Brain Injury
This study is trying out a special exercise program to see if it can help people with lingering symptoms after a mild brain injury feel better and improve their overall health compared to those getting regular rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sunnaas Rehabilitation Hospital Academic / other |
| Locations | 2 sites (Nesoddtangen and 1 other locations) |
| Trial ID | NCT06177509 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a graded aerobic exercise program on patients suffering from persistent post-concussive symptoms (PCS) following mild traumatic brain injury (mTBI). It aims to determine if this exercise regimen can reduce symptom burden, improve exercise tolerance, and enhance overall health-related quality of life compared to a control group receiving standard rehabilitation. The study will utilize the Buffalo Concussion Treadmill Test to assess exercise intolerance and will measure autonomic nervous system function through MRI and other tests. Participants will be randomized into either the intervention or control group for a 12-week period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of mild TBI and persistent post-concussive symptoms lasting between 3 months to 2 years.
Not a fit: Patients with other neurological or severe psychiatric conditions, heart-lung disease, or those unable to participate in physical exercise will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate symptoms and improve quality of life for patients with mild traumatic brain injury.
How similar studies have performed: Previous studies have shown promise in using graded exercise for concussion recovery, but this specific approach in adults with PCS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nesoddtangen and 1 other locations
- Sunnaas rehabilitation hospital — Nesoddtangen, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Marianne Løvstad, Professor — Head of psychology
- Study coordinator: Marianne Løvstad, Professor
- Email: mar.lovstad@gmail.com
- Phone: +4793452003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.