Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06177509

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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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