Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury

NCT05086419 | Active Not Recruiting

• 1 other identifier: REK #256109
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This Randomized Controlled Trial (RCT) will explore the effect of sub-symptom threshold aerobic exercise on persistent post-concussion symptoms and exercise intolerance in patients with mild Traumatic Brain Injury (TBI). The hypothesis is that sub-symptom training will reduce the symptom pressure, normalize exercise tolerance, reduce patient-specific activity limitations and improve health-related quality of life. To improve the chances of conducting a high-quality RCT, a feasibility trial will be completed prior to the definitive RCT.

Conditions

Mild Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury; Buffalo Concussion Treadmill Test; Sub-symptom aerobic exercise

Outcome Measures

Primary Outcomes (1)

• Change on the Rivermead Post Concussion Symptoms Questionnaire - RPQ

  A 16-item standardized and validated questionnaire designed to measure the severity of post-concussion symptoms following TBI. 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 a widely used in TBI and persistent post-commotio symptoms research. The minimum clinically important difference (MCID) is 4.6 points.

  12 weeks and 6 months.

Secondary Outcomes (1)

• Change on the Buffalo Concussion Treadmill Test - BCTT

  12 weeks and 6 months.

Other Outcomes (7)

• Change on the Patient-specific functional scale (PSFS)

  12 weeks and 6 months.

• Change on the Quality of life after brain injury - Overall Scale (QOLIBRI - OS)

  12 weeks and 6 months.

• Change on the Patient Health Questionnaire (PHQ-9)

  12 weeks and 6 months.

Study Arms (2)

Exercise group

EXPERIMENTAL

The exercise group will in addition to treatment as usual, receive sub-symptom threshold aerobic exercise for approx. 30 minutes 3-5x / week for 12 weeks. Sub-symptom threshold aerobic exercise is based on the individual patient's symptom threshold and will be between 80-90% of the maximum heart rate achieved during testing/BCTT. To ensure proper exercise dosage and progression, participants will be retested every 3 weeks. An experienced doctor and / or physiotherapist will carry out the testing and guide the participants in the content and dosage (duration, intensity, and frequency) of the sub-symptom threshold aerobic exercise/intervention.

Other: Sub-symptom threshold aerobic exercise

Treatment as usual group

NO INTERVENTION

The treatment as usual group will receive 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. The interdisciplinary team consists of a specialist in physical medicine and rehabilitation, neuropsychologist, occupational therapist, physiotherapist, and social worker. The main focus is on stabilizing the level of function in everyday life and gradual return to work and education. Participants receive general advice on physical activity based on recommendations from the Norwegian Directorate of Health, but not specific guidance in sub-symptom threshold aerobic exercise and help with exercise dosage (frequency, duration and intensity).

Interventions

Sub-symptom threshold aerobic exercise OTHER

For the first three weeks, participants will be offered guided sub-symptom threshold aerobic exercise on a treadmill or exercise bike once a week. The remaining 2-4 sub-symptom threshold aerobic exercise workouts per. week will be on their own. Location and mode of exercise (treadmill, walking, jogging, exercise bike / bicycle, swimming, or elliptical machine) will be individually adapted to the patients experience, preferences and opportunities. The intensity of the sub-symptom threshold aerobic exercise will always be monitored using a heart rate monitor and/or ratings of perceived exertion (Borg RPE). If there still is a need for closer follow-up after the first three weeks, a physiotherapist in primary health care service will be involved under supervision from a physiotherapist (research fellow) in the project.

Exercise group

Eligibility Criteria

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

You may qualify if:

• Patients with mild TBI defined by the World Health Organization (WHO) Collaborating Center Task Force definition: 1) one or more of the following: confusion or disorientation, loss of consciousness (LOC) ≤30 minutes, post-traumatic memory loss (PTA) ≤24 hours and / or transient neurological focal deficits and intracranial lesions that do not require surgery; 2) Glasgow Coma Scale (GCS) score of 13-15 at least 30 minutes after trauma).
• years with persistent post-commotio symptoms (minimum 3 months maximum 2 years).
• Reduced tolerance to physical activity/exercise intolerance (self-reported worsening of symptoms such as dizziness and headache during physical activity and exercise).

You may not qualify if:

• Other neurological or psychiatric conditions (not including anxiety and depression) listed in the medical record. Heart-lung disease, extremity injuries that prevent physical exercise, drug addiction and insufficient understanding of the Norwegian language (unable to follow instructions and/or fill in forms). Normal BCTT.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

• Valaas LV, Soberg HL, Rasmussen MS, Steenstrup SE, Andelic N, Kleffelgard I. Sub-symptom threshold aerobic exercise for patients with persisting post-concussion symptoms and exercise intolerance after mild traumatic brain injury - a study protocol with a nested feasibility study for a randomized controlled trial. BMC Neurol. 2023 May 3;23(1):179. doi: 10.1186/s12883-023-03221-7.

  PMID: 37138202 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Ingerid Kleffelgård, Phd

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After written informed consent, patients will be randomized to the intervention or control group using computer-generated lists. Block randomization with variable block size that is unknown to the research group will be used. Follow-up tests at T1 and T2 will be performed by a research assistant who is blind to the group distribution and who is not involved in any parts of the intervention. Statisticians will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 20, 2021
• Study Start: October 1, 2021
• Primary Completion: May 23, 2024
• Study Completion: November 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)