Stroke
Conditions
Keywords
physical activity, relaxation, activities of daily living, motor functions, cognitive functions
Brief summary
The aim of this study is to investigate whether a 4-week physical fitness training (target intervention) in stroke patients (subacute stage) increase the walking speed and activities of daily living compared with a control intervention (relaxation exercises). The target or control intervention is performed in addition to standard rehabilitation treatment.
Interventions
PROCEDUREphysical fitness training
PROCEDURErelaxation
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
for patients: * diagnosis of stroke within 5-45 days after stroke * age \>= 18 years * able to sit for at least 30 seconds * Barthel index \< =65 at inclusion * considered able to perform aerobic exercise as determined by responsible physician * Written informed consent of the patient
Exclusion criteria
* Patient considered unable to comply with study requirements * stroke due to intracranial hemorrhage primarily due to bleeding from ruptured aneurysm or arteriovenous malformation * patients with progressive stroke * unable to perfom the required exercises due to 1. medical problems 2. musculo-skeletal problems 3. neurological problems * required help to at least 1 persons to walk before stroke due to neurological or non-neurological co-morbidities * life expectancy of less than 1 year as determined by responsible physician * alcohol or drug addiction within the last 6 months * significant current psychiatric illness as defined as medication-refractory of bipolar affective disorder, psychosis, schizophrenia or suicidality * current participation in another intervention study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait speed and Barthel Index (BI) (co-primary endpoint) | 3 months post stroke vs baseline | comparing gait speed (m/s) and points achieved in BARTHEL Index in aerobic and non-aroebic training group 3 months after stroke vs baseline (before intervention) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait speed and Barthel Index (BI) | directly after intervention; 6 months post stroke; all vs baseline | comparing gait speed (m/s) and points achieved in BI in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 6 months post stroke vs baseline (before intervention) |
| motor function | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing motor function (assessed via different clinical scales e.g. Rivermead Arm test, REPAS, Box and Block Test, Medical Research Council Scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| mobility | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing different mobilitiy indices like gait endurance (in min), stride length, step cadence, use of walking aids, actigraph measurements and the Rivermead mobility Index in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| cognitive function | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing cognitive function (assessed via points achieved in different scales, e.g. Montreal Cognitive Assessment, Trail Making test, word fluency) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| Disability | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing disability (Modified rankin scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| Quality of life (QoL) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing QoL (EQ-5D-5L scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| sleep | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing sleep quality (Pittsburgh sleep quality index) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| mood | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing mood (CES-D scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| Physical fitness | directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline | comparing gait energy Expenditure in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| Assessment of safety | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing different criteria (recurrent fatal or non-fatal cardiovascular or cerebrovascular events, refferal to acute hospital, death) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention) |
| Maximal walking speed and Barthel-Index | 3 months post stroke vs. baseline | per Protocol analysis of co-primary endpoint (pre-specified in statistical analysis plan and protocol) |
Other
| Measure | Time frame | Description |
|---|---|---|
| resting systolic and diastolic blood pressure | directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline | comparing resting systolic and diastolic blood pressure (mmHg) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| laboratory parameters | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing different laboratory parameters (derived by blood draw) like hormones, hemogram, liver and kidney function, and coagulation parameters in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| hair cortisol concentration | at baseline | hair cortisol concentration by taking a small strand of hair is measured at baseline; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| resting heart rate | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comaparing resting heart rate(beats/minute) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| waist to hip ratio | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing waist to hip ratio (cm) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| markers of peripheral immunity | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comapring markers of peripheral immunity (e.g., monocytic HLA-DR expression) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| lipid profile | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing lipide such as triglycerides, cholesterol (total, LDL,HDL, and LP(a)) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| blood glucose | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing insulin, glucose, and HbA1c in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| markers of inflammation | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing markers of inflammation (e.g., including Interleukin (IL) 6, 1b, hs-CRP) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| body mass index | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline | comparing body mass index in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| Endothelial function | directly after intervention vs. baseline | the endothelial function of included patients will be assessed prospectively before and after the 4 week intervention with the Endopat2000 device. First measurement was conducted in January 11th 2014. Results will be correlated with imaging and blood-derived biomarkers as well as differences between intervention groups; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
| Magnetic resonance imaging parameters | directly after intervention vs. baseline | Primary and secondary endpoints are specified after completion of the interim analysis after inclusion of the first 24 patients (first stage). In a second stage the study is conducted with specified primary and secondary endpoints with recruitment of up to 76 remaining patients; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately) |
Countries
Germany
Outcome results
None listed