Better Understanding of Fatigue After STroke

Official Summary

Stroke is worldwide the second most common cause of death following heart attack and the leading cause of disability. Post-stroke fatigue (PSF) is a common complication after stroke and can be defined as 'an overwhelming exhaustion or tiredness, not related to exertion, which does not typically improve with rest'. Fatigue following stroke can be divided into early (\< 3 months) and late (\> 3 months) fatigue. PSF can have a considerable impact on a person's everyday activities and quality of life, participation in the rehabilitation process and levels of caregiver burden. Yet no efficient treatment exists to prevent or cure PSF because the pathophysiology remains unclear and seems to be multifaceted. Autonomic dysfunction is a common complication after stroke, associated with higher morbidity and mortality. An easy tool to measure the function of the autonomic nervous system (ANS) is heart rate variability (HRV), which is defined as the beat-to-beat variation of the heart rate (= interbeat interval (IBI)). It is the result of alterations in the sympathetic and parasympathetic nervous system. In recent systematic reviews, authors stipulate that HRV can be regarded as a prognostic factor for short- and long-term stroke outcomes. HRV can be derived from 24 hours, 5 minutes (short-term) and \< 5 minutes (ultra-short-term) measurements by applying time-domain and frequency-domain indices. Autonomic dysfunction has been related to chronic fatigue syndrome, in addition to fatigue in multiple sclerosis, Parkinson's disease and myasthenia gravis. However, to the best of our knowledge, the relationship between autonomic dysfunction and PSF has not yet been fully investigated. Fatigue is also common in cardiovascular diseases, especially in patients with heart failure (HF). HF can contribute to fatigue after stroke, independently of stroke. Cardiac complications after acute ischemic stroke (AIS), such as arrhythmias, cardiac dysfunction and myocardial injury, are frequent.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 250 participants

Interventions

• DIAGNOSTIC_TEST: ECG — An electrocardiogram (ECG) is a simple, non-invasive test that records the electrical activity of the heart.
• DIAGNOSTIC_TEST: Transthoracic echography (TTE) — A transthoracic echocardiogram (TTE) is a test that uses ultrasound (sound waves) to create images of the heart.
• DIAGNOSTIC_TEST: Blood sampling — Blood sampling will include: complete blood count, serum creatinine and electrolytes, liver enzymes, fast lipid profile, glucose, HbA1C, thyroid-stimulating hormone (TSH), CRP, iron status, cardiac troponin (cTnT), N-terminal pro-brain natriuretic peptide (NT-proBNP).

Primary Outcomes

• Heart rate variability (HRV) (Baseline (hospital admission))
• Heart rate variability (HRV) (3 months after baseline)
• Heart rate variability (HRV) (12 months after baseline)
• Transthoracic echography (TTE) (Baseline (hospital admission))
• Transthoracic echography (TTE) (3 months after baseline)

Secondary Outcomes

• Blood CRP level (Baseline (hospital admission))
• Blood neutrophil-to-lymphocyte ratio (NLR) (Baseline (hospital admission))
• Stroke localization in the brain (Baseline (hospital admission))
• Fazekas scale (Baseline (hospital admission))
• Global cortical atrophy scale (Baseline (hospital admission))

Trial Locations

• CHU Brugmann, Brussels, Belgium
• UZ Brussel, Brussels, Belgium

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