Cardiometabolic homeostasis during early aerobic fitness training after stroke (Early-Fit)
- Conditions
- I63I61Cerebral infarctionIntracerebral haemorrhage
- Registration Number
- DRKS00032233
- Lead Sponsor
- Charité Campus Charité Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
1. Male or female adult = 18 years of age at time of enrolment
2. Provision of written informed consent of the patient
3. Acute stroke (ischemic stroke or intracerebral haemorrhage) diagnosed on computed tomography (CT) or magnetic resonance imaging (MRI)
4. Time period of inclusion within 3-21 days after stroke onset (stroke rehabilitation care)
5. Length of stay at neurological early rehabilitation ward planned for at least two weeks
6. Considered able to perform aerobic exercise, as determined by multidisciplinary rehabilitation team (physiotherapists, physicians (e.g. cardiologist on request))
7. Able to stand and take = 1 step without assistance
8. Diagnosis of Diabetes mellitus (Previously existing, taking antidiabetic agents as well as newly diagnosed) or pre-diabetes (HbA1c: 5,7-6,4%) or Atrial fibrillation without IGM
1. Current participation in another interventional trial
2. Presence of persisting vessel occlusion corresponding to the location of the ischemic stroke
a. Intracranial (A. cerebri anterior Segment A1, A. cerebri media Segment M1 or, M2, A. cerebri posterior segment P1, A. basilaris)
b. Extracranial (A. carotis communis or interna)
3. Symptomatic stenosis of carotid arteries (Stenosis needing a surgical intervention) or high grade basilar artery stenosis
4. Comorbidities contraindicated for aerobic exercise and cardiopulmonary exercise testing such as severe pulmonary, cardiac (severe cardiac arrhythmias or blocks (second- or third-degree AV block), and neurological diseases, recent bone fractures
5. Acute renal failure (Increase Serum Creatinine x3, Glomerular filtration rate decrease 75% or Serum Creatinine > 4mg/dl)
6. Systemic infection with fever and / or requiring antibiotic treatment such as pneumonia and endocarditis
7. Insufficiently controlled arterial hypertension within the last 48 hours (systolic >170mmHg and/or diastolic >110 mmHg)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycemic variability defined as coefficient of variation of blood glucose (during intervention)
- Secondary Outcome Measures
Name Time Method