NCT06177509

Effect of Graded Aerobic Exercise in Mild Traumatic Brain Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Sunnaas Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: TBI is a public health challenge of considerable, but insufficiently recognized proportions. Therefore, a concerted effort should be made to reduce the burden and impact of TBI. Health care providers are in need of standardization of the medical examination and targeted individual interventions with potential to treat PCS. Main purpose: The main purpose of this study is to evaluate whether a progressive, sub-symptom threshold aerobic exercise program in addition to ordinary rehabilitation will lead to clinically meaningful reduction in symptom burden, normalize exercise tolerance and improve health-related quality of life compared to a control group that only receives ordinary rehabilitation. In addition, changes in ANS function will be assessed in both the intervention and the control group. Design: Randomized, controlled, single-blind parallel-group study with two measurement points; T0 at baseline and T1 after the intervention. Method: The Buffalo Concussion Treadmill Test (BCTT) will be used to expose exercise intolerance, and participants with exercise intolerance will be randomized to the intervention group or the control group. Both groups will receive ordinary rehabilitation. The intervention group will in addition receive an individualized (based on BCTT) sub-symptom threshold aerobic exercise program for 12 weeks. To assess ANS function, Arterial spin labeling (ASL) MRI and Cold Pressor Test (CPT) will be performed at T0 and T1. Symptom burden will be assessed by Rivermead Post-concussion Symptom Questionnaire (RPQ) and other patient reported outcomes measurements including self-reported autonomic symptoms (the Composite Autonomic Symptom Score 31) will also be used. Clinical relevance: Self-reported ANS, exercise intolerance testing, the CPT and ASL-MRI could prove to be useful clinical assessment tools to confirm the PCS-diagnosis and to determine readiness to return to preinjury level of day-to-day activities.

Conditions

• Traumatic Brain Injury
• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2023-11-17
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-12-20
• Last updated: 2023-12-20

Locations

2 sites across 1 country: Norway