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
158 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
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.
CONDITIONS
Official 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 persistent post-concussive symptoms based on ICD-10 criteria lasting from 3 months to 2 years
- Age between 18 and 60 years
- Reduced tolerance to physical activity or exercise intolerance, or have not yet tried physical activity after injury
You will not qualify if you...
- Other neurological or severe psychiatric conditions noted in medical records
- Heart or lung disease
- Injuries to limbs preventing physical exercise
- Drug addiction
- Insufficient understanding of Norwegian language to follow instructions or complete forms
- Normal Buffalo Concussion Treadmill Test (BCTT) results
AI-Screening
AI-Powered Screening
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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
CONTACT
L
Lars Nysæther, MD
CONTACT
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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