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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physical fitness training | Experimental | aerobic physical fitness training |
|
| relaxation | Active Comparator | non-aerobic training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical fitness training | Procedure |
| ||
| relaxation |
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed and Barthel Index (BI) (co-primary endpoint) | 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) | 3 months post stroke vs baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed and Barthel Index (BI) | 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) | directly after intervention; 6 months post stroke; all vs baseline |
| Measure | Description | Time Frame |
|---|---|---|
| resting systolic and diastolic blood pressure | 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) |
Inclusion Criteria for patients:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beelitz Heilstätten | Beelitz-Heilstätten | Brandenburg | 14547 | Germany | ||
| Median Klinik Grünheide |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24491065 | Background | Floel A, Werner C, Grittner U, Hesse S, Jobges M, Knauss J, Seifert M, Steinhagen-Thiessen E, Govercin M, Dohle C, Fischer W, Schlieder R, Nave AH, Meisel A, Ebinger M, Wellwood I. Physical fitness training in Subacute Stroke (PHYS-STROKE)--study protocol for a randomised controlled trial. Trials. 2014 Feb 3;15:45. doi: 10.1186/1745-6215-15-45. | |
| 41929475 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Statistical Analysis Plan | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2017 | Jun 4, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| motor function |
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) |
| directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| mobility | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| cognitive function | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| Disability | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| Quality of life (QoL) | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| sleep | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| mood | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| Physical fitness | 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) | directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline |
| Assessment of safety | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| Maximal walking speed and Barthel-Index | per Protocol analysis of co-primary endpoint (pre-specified in statistical analysis plan and protocol) | 3 months post stroke vs. baseline |
| directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline |
| laboratory parameters | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| hair cortisol concentration | 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) | at baseline |
| resting heart rate | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| waist to hip ratio | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| markers of peripheral immunity | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| lipid profile | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| blood glucose | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| markers of inflammation | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| body mass index | 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) | directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline |
| Endothelial function | 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) | directly after intervention vs. baseline |
| Magnetic resonance imaging parameters | 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) | directly after intervention vs. baseline |
| Grünheide |
| Brandenburg |
| 15537 |
| Germany |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Charité Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Vivantes Klinikum Neukölln | Berlin | 12351 | Germany |
| Evanglisches Geriatriezentrum Berlin | Berlin | 13347 | Germany |
| Medical Park Berlin | Berlin | 13507 | Germany |
| Pietrock C, Neumann K, Rentzsch K, Pruss H, Meisel A, Endres M, Nave AH. Neuronal autoantibodies associated with poorer neuropsychological and motor outcomes 6 months after stroke: results from the PHYS-STROKE trial. Front Immunol. 2026 Mar 18;16:1678840. doi: 10.3389/fimmu.2025.1678840. eCollection 2025. |
| 39649709 | Derived | Rackoll T, Hinrichs T, Neumann K, Wolfarth B, Nave AH; Phys-Stroke Study Group. Improvements in Walking During Subacute Stroke Rehabilitation Translate to Physical Activity at the Chronic Stage: A Sub-Analysis From the Phys Stroke Trial. Brain Neurorehabil. 2024 Oct 28;17(3):e17. doi: 10.12786/bn.2024.17.e17. eCollection 2024 Nov. |
| 34512526 | Derived | Kirzinger B, Stroux A, Rackoll T, Endres M, Floel A, Ebinger M, Nave AH. Elevated Serum Inflammatory Markers in Subacute Stroke Are Associated With Clinical Outcome but Not Modified by Aerobic Fitness Training: Results of the Randomized Controlled PHYS-STROKE Trial. Front Neurol. 2021 Aug 26;12:713018. doi: 10.3389/fneur.2021.713018. eCollection 2021. |
| 31533934 | Derived | Nave AH, Rackoll T, Grittner U, Blasing H, Gorsler A, Nabavi DG, Audebert HJ, Klostermann F, Muller-Werdan U, Steinhagen-Thiessen E, Meisel A, Endres M, Hesse S, Ebinger M, Floel A. Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial. BMJ. 2019 Sep 18;366:l5101. doi: 10.1136/bmj.l5101. |
Statistical Analysis Plan of PHYS-Stroke Trial. If download path is offline please contact torsten.rackoll@charite.de |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |