Actively Recruiting
Effect of Graded Aerobic Exercise in Mild Traumatic Brain Injury
Led by Sunnaas Rehabilitation Hospital · Updated on 2023-12-20
72
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sunnaas Rehabilitation Hospital
Lead Sponsor
O
Oslo University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a progressive, sub-symptom threshold aerobic exercise program on adults with persistent symptoms after mild traumatic brain injury (mTBI), also known as post-concussion syndrome (PCS). This condition affects 20% to 30% of individuals following mTBI and can cause ongoing symptoms including exercise intolerance and autonomic nervous system (ANS) dysfunction. The study aims to better understand the neurobiological factors involved in PCS and to develop targeted interventions for those with lasting symptoms. Participants with exercise intolerance will be randomly assigned to either an intervention group or a control group. The intervention group will receive a personalized aerobic exercise program to be done approximately 3 to 5 times per week for 12 weeks, exercising at 80-90% of their maximum heart rate threshold assessed by the Buffalo Concussion Treadmill Test (BCTT). They will have one guided session weekly for the first three weeks and will perform other sessions independently, using various activities like walking, jogging, or swimming, monitored by heart rate and perceived exertion scales. The control group will receive standard outpatient rehabilitation from a multidisciplinary team. During the study, participants will undergo medical examinations and assessments including BCTT, Arterial Spin Labeling MRI, and the Cold Pressor Test to evaluate ANS function and symptom burden. Symptom severity will be measured using the Rivermead Post-concussion Symptom Questionnaire and other patient-reported outcomes. Exercise adherence will be tracked through diaries and weekly follow-ups. The main outcome is symptom improvement after 12 weeks, with safety and quality of life also monitored. The study lasts 12 weeks with assessments at baseline and after the intervention.
CONDITIONS
Brief Title
Effect of Graded Aerobic Exercise in Mild Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mild traumatic brain injury as defined by the World Health Organization (WHO)
- Diagnosis of post-concussion syndrome (PCS) based on ICD-10 criteria lasting between 3 months and 2 years
- Age between 18 and 60 years
- Reduced tolerance to physical activity or exercise intolerance, or no prior physical activity since injury
You will not qualify if you...
- Presence of other neurological or severe psychiatric conditions
- Heart or lung disease
- Injuries to limbs preventing physical exercise
- Drug addiction
- Insufficient understanding of Norwegian language
- Normal Buffalo Concussion Treadmill Test (BCTT) results
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive ordinary rehabilitation. Those in the intervention group also follow a sub-symptom threshold aerobic exercise program approximately 30 minutes, 3 to 5 times per week for twelve weeks, with retesting every three weeks and weekly guided exercise sessions during the first three weeks.
Weekly visits for retesting and guided exercise sessions during the first three weeks; additional self-guided exercise sessions 3 to 5 times per week
Duration - At baseline and after 12 weeks
Participants undergo assessments at baseline and after the 12-week intervention including symptom questionnaires, exercise tolerance tests, and autonomic nervous system function tests.
2 visits (in-person) for assessments
Trial Site Locations
Total: 2 locations
1
Sunnaas rehabilitation hospital
Nesoddtangen, Norway, 1453
Actively Recruiting
2
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
M
Marianne Løvstad, Professor
L
Lars Nysæther, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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