Effect of Graded Aerobic Exercise in Mild Traumatic Brain Injury

NCT06177509 | Recruiting

• 1 other identifier: Gradert trening ved mTBI
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Traumatic Brain Injury; Mild Traumatic Brain Injury

Keywords

post-concussion symptoms; autonomic nervous system dysfunction; Buffalo concussion treadmill test

Outcome Measures

Primary Outcomes (1)

• Change on the Rivermead Post-concussion Symptom Questionnaire (RPQ)

  A 16-item standardized and validated questionnaire designed to measure the severity of post-concussive symptoms following mTBI. The five-point ordinal scale ranges from 0 (no problem) to 4 (severe problem). The total score ranges from 0-64, with higher scores indicating a higher symptom load. RPQ has satisfactory psychometric properties and is widely used in mTBI and persistent post-concussive symptoms research. The minimal clinically important difference (MCID) is 4,6 points.

  Baseline and 12 weeks

Secondary Outcomes (6)

• Change on the Cold Pressor Test Cold Pressor Test

  Baseline and 12 weeks

• Change on Arterial spin labeling (ASL)

  Baseline and 12 weeks

• Change on the Buffalo Concussion Treadmill Test (BCTT)

  Baseline and 12 weeks

• Change on 0-10 Numeric Rating Scale (NRS) in Concussion Symptom Burden

  Baseline and 12 weeks

• Change on Borg scale - Rating of Perceived Exertion (RPE)

  Baseline and 12 weeks

Other Outcomes (6)

• Change on the Composite Autonomic Symptom Score 31 (COMPASS 31)

  Baseline and 12 weeks

• Change on the Quality of life after TBI (Qolibri) OA scale

  Baseline and 12 weeks

• Change on the International Physical Activity Questionnaires (IPAQ)

  Baseline and 12 weeks

Study Arms (2)

Intervention group - Graded Aerobic Exercise

EXPERIMENTAL

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.

Other: Graded Aerobic Exercise

Control group - Outpatient multidisciplinary follow-up (Treatment as usual - TAU)

NO INTERVENTION

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.

Interventions

Graded Aerobic Exercise OTHER

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.

Intervention group - Graded Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Other neurological or severe psychiatric conditions listed in the medical record.
• Heart-lung disease.
• Extremity injuries that prevent physical exercise
• Drug addiction
• Insufficient understanding of the Norwegian language (unable to follow instructions and/or fill in forms).
• Normal BCTT.

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• Oslo University Hospital: collaborator
• Oslo Metropolitan University: collaborator

Study Sites (2)

Sunnaas rehabilitation hospital

Nesoddtangen, 1453, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Marianne Løvstad, Professor

  Head of psychology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Løvstad, Professor

CONTACT

+4793452003; mar.lovstad@gmail.com

Lars Nysæther, MD

CONTACT

4792466685; mar.lovstad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, single-blind parallel group design.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 20, 2023
• Study Start: November 17, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

NO (2)