Comparing exercise programs for recovery after mild head injury
Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache. A Randomized Controlled Trial.
This study is testing two different ways of providing exercise support to see which helps people recover better after a mild head injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT06015451 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different exercise delivery models for patients experiencing exercise intolerance following a mild head injury. Participants will undergo a treadmill test to establish their symptom threshold and will then engage in a tailored exercise program. One group will receive in-person follow-up and repeated testing, while the other will have telephone-based follow-up. The study will assess recovery outcomes after 12 weeks of exercise intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have sustained a mild traumatic brain injury and experience exercise intolerance.
Not a fit: Patients with severe communication issues or those whose symptoms are better explained by other conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery strategies for patients suffering from post-concussion symptoms and enhance their quality of life.
How similar studies have performed: Other studies have shown promising results with similar exercise interventions for post-concussion recovery, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-65 years * Having sustained a minimal head injury or mild traumatic brain injury at least 2 weeks ago. * At least one postconcussion symptoms, of at least moderate degree, occurring within the first week after the head injury. * Intolerance for physical activity (self-reported and measured; including symptom exacerbation later on the test day). * Capable of giving informed consent. Exclusion Criteria: * More than 2 years since last injury. * The symptoms are better explained by other conditions. * Severe communication problems, typically due to poor knowledge of Norwegian. * Severe psychiatric, neurological, somatic, or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment. * Safety concerns according to the study medical checklist.
Where this trial is running
Trondheim
- St. Olavs Hospital, Clinic of Rehabilitation — Trondheim, Norway (Recruiting)
Study contacts
- Study coordinator: Toril Skandsen, PhD
- Email: toril.skandsen@ntnu.no
- Phone: +4792692780
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.