Clinical Trial Protocol
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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 Neurology 2023 May 4
BACKGROUND: Persistent post-concussion symptoms (PPCS) affect between 34 and 46% after a mild traumatic brain injury (mTBI). Many also experience exercise intolerance. Sub-symptom threshold aerobic exercise, SSTAE (exercise at an intensity level that does not increase symptoms) is proposed as a treatment to both reduce the symptom burden and increase the exercise tolerance after the injury. It is unclear if this also applies in a more chronic phase after mTBI.

MAIN PURPOSE: The main purpose of this study is to evaluate whether SSTAE 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.

METHODS: Patients between the ages of 18 and 60 with exercise intolerance and persistent PPCS (> 3 months) will be recruited to the study and randomized to two groups. All patients will receive follow-up at the outpatient TBI clinic. The intervention group will in addition receive SSTAE for 12 weeks with exercise diaries and a retest every 3 weeks for optimal dosage and progression. The Rivermead post-concussion symptoms questionnaire will be the main outcome measure. The secondary outcome measure will be a test of exercise tolerance-the Buffalo Concussion Treadmill Test. Other outcome measures include the patient-specific functional scale that measures patient-specific activity limitations, as well as outcome measures for diagnosis-specific health-related quality of life, anxiety and depression, specific symptoms such as dizziness, headache and fatigue, and physical activity.

DISCUSSION: This study will add knowledge about the effect of SSTAE and whether it should be implemented in rehabilitation for the adult population with persistent PPCS after mTBI. The nested feasibility trial showed that the SSTAE intervention was safe and that the study procedures and delivery of the intervention overall were feasible. However, minor amendments to the study protocol were made prior to the commencement of the RCT.

TRIAL REGISTRATION: Clinical Trials.gov, NCT05086419. Registered on September 5th, 2021.

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