Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Study Overview
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Brief Summary
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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.

Official Title
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Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Conditions
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Stroke

Intervention / Treatment
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* Procedure: physical fitness training
* Procedure: relaxation


Participation Criteria
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Eligibility Criteria
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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 medical problems musculo-skeletal problems 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical fitness training<br>aerobic physical fitness training | Procedure: physical fitness training<br> <br> |
| Active Comparator: relaxation<br>non-aerobic training | Procedure: relaxation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, relaxation, activities of daily living, motor functions, cognitive functions