I63 I61
Conditions
Interventions
Group 1: Intervention group
- receives a minimum of six and a maximum of nine sessions of treadmill-based aerobic training as part of physical therapy
Group 2: Control group
- receives the usual phys
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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 take 3 steps with assistance of one person 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
Exclusion criteria
Exclusion criteria: 1. Current participation in another interventional trial 2. Symptomatic stenosis of carotid arteries (Stenosis needing a surgical intervention) or high grade basilar artery stenosis 3. Comorbidities contraindicated for aerobic exercise such as severe pulmonary, cardiac (severe cardiac arrhythmias or blocks (second- or third-degree AV block), and neurological diseases, recent bone fractures 4. Acute renal failure (Increase Serum Creatinine x3, Glomerular filtration rate decrease 75% or Serum Creatinine > 4mg/dl) 5. Systemic infection with fever and / or requiring antibiotic treatment such as pneumonia and endocarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic variability defined as coefficient of variation of blood glucose (during intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous measurement (14+14 days) 1. Glycemic variability - Standard deviation of blood glucose (SDBG) - Mean amplitude of glycemic excursion (MAGE) - Mean glucose - Hemoglobin Glycation Index (HGI) - Time in Ranges (%) (target (3,9-10 mmol/L), hypoglycemia (10mmol/L)) o HbA1c - Area under the curve - Episodes of hypoglycemia (10 mmol/L)) V2 und V3 2. Safety (all-cause mortality, combined cardiovascular events (fatal and non-fatal stroke, myocardical infarction), re-hospitalization, frequency and severity of falls) V1, V2 und V3 3. Subjective scores (EHIS-PAQ, fatigue, motivation, dizziness, pain, EQ-5D5L) 4. Functional and clinical scores ((pre)mRS, NIHSS, Timed up andGo, Barthel Index) V1 und V2 5. Sprioergometry parameter (e.g. oxygen uptake at anaerobic threshold (VO2AT)) 6. Blood Biomarker (NFL, Troponin, etc.) - Leukocyte Profile (Monocytes, T-cells, Granulocytes, NK-cells) will be assessed by flow cytometry and cardiovascular and inflammatory plasma proteins (OLINK or somalogic), inflammatory cytokines and microvesicles | — |
Countries
Germany
Contacts
Public ContactAlexander Heinrich Nave
Klinik und Hochschulambulanz für Neurologie der Charité, CCM | CVK Charité – Unversitätsmedizin Berlin und Centrum für Schlaganfallforschung Berlin
Outcome results
None listed