Effect of Graded Aerobic Exercise in Mild Traumatic Brain Injury

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Sunnaas rehabilitation hospital
RECRUITING
Nesoddtangen
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Marianne Løvstad, Professor
mar.lovstad@gmail.com
+4793452003
Backup
Lars Nysæther, MD
mar.lovstad@gmail.com
4792466685
Time Frame
Start Date: 2023-11-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 72
Treatments
Experimental: Intervention group - Graded Aerobic Exercise
Participants will follow a sub-symptom aerobic exercise program (approx. 30 min) 3 - 5 times pr week for twelve weeks. Sub-symptom threshold aerobic exercise means to exercise at 80-90% of the maximum threshold heart rate achieved during the BCTT. To ensure proper exercise dose and progression, participants will be retested every three weeks. During the first three weeks, the participants will be offered one weekly guided exercise session. The other 2 - 4 weekly sessions the participants will carry out on their own, choosing activities based on experience, preferences and possibilities (e.g. walking, jogging, stationary bike, swimming). The intensity of the sub-symptom threshold aerobic exercise will be monitored using a heart rate monitor and the BORG scale. Compliance with the sub-symptom threshold aerobic exercise program will be recorded by the patients in an exercise diary, which is followed up by a weekly reminder over the phone/sms by a physiotherapist in the project.
No_intervention: Control group - Outpatient multidisciplinary follow-up (Treatment as usual - TAU)
TAU includes assessment and treatment provided by a multidisciplinary outpatient rehabilitation team. Patients will undergo a medical examination and assessment of physical, cognitive, and mental health and functioning, followed by individually adapted rehabilitation program. The interdisciplinary team consists of a specialist in physical medicine and rehabilitation, (neuro)psychologist, occupational therapist, physiotherapist, and social worker. The main focus is on improving the level of function in everyday life and gradual return to work and education.
Related Therapeutic Areas
Sponsors
Leads: Sunnaas Rehabilitation Hospital
Collaborators: Oslo University Hospital, Oslo Metropolitan University

This content was sourced from clinicaltrials.gov