Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury

Mild Traumatic Brain Injury Clinical Trial

Official title: Sub-symptom Threshold Aerobic Exercise Training for Patients With Exercise Intolerance and Persistent Symptoms After Mild Traumatic Brain Injury - A Randomized Controlled Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Background: Persistent post-commotio symptoms (PCS) affect between 34% and 46% of individuals after a mild traumatic brain injury (TBI). Many also experience exercise intolerance. Sub-symptom threshold aerobic exercise (exercise at an intensity level that does not increase symptoms) is proposed as treatment both to increase the exercise tolerance and to ease the symptom burden after the injury.

Main purpose: The main purpose of this study is to evaluate whether a progressive sub-symptom threshold exercise program in addition to ordinary rehabilitation will lead to clinically meaningful improvement of symptom burden, normalize exercise tolerance, increase physical activity, improve health-related quality of life, and reduce patient-specific activity limitations compared to a control group that only receives ordinary rehabilitation.

Design: Randomized, controlled, single-blind parallel-group study with three measurement times; T0 at baseline, T1 after the intervention and T2 six months after T1.

Method: 68 patients between the ages of 18 and 60 with exercise intolerance and persistent PCS will be recruited to the study and randomized to two groups. All participants will receive ordinary rehabilitation. The intervention group will in addition receive sub-symptom threshold aerobic exercise for 12 weeks with weekly follow-up by a physiotherapist and a retest every 3 weeks for optimal dosage and progression. Rivermead post-concussion symptoms questionnaire (RPQ) will be the main outcome measure. The secondary outcome measure will be a test of exercise tolerance - the Buffalo Concussion Treadmill Test (BCTT). Other outcome measures include the patient-specific functional scale that measures patient-specific activity limitations, as well as outcome measures for health-related quality of life, anxiety and depression, specific symptoms such as dizziness, headache and fatigue, and level of physical activity.

Clinical relevance: Since people with persistent symptoms after mild TBI often have reduced level of functioning and difficulty working / studying full time, there is a great need for an individually tailored intervention that has the potential to reduce persistent symptoms and improve functioning This project will increase the evidence based knowledge about the effect of sub-symptom threshold aerobic exercise in patient with persistent symptoms after mild TBI. ;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT05086419
• Study type: Interventional
• Source: Oslo University Hospital
• Contact: Lars-Johan Viddal Valaas, Msc.
• Phone: 45204747
• Email: lavala@ous-hf.no
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Completion date: August 15, 2025