Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Phase 3CompletedNCT01953549

Charite University, Berlin, Germany200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Stroke

Interventions

physical fitness trainingPROCEDURE

relaxationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (7)

Beelitz Heilstätten

Beelitz-Heilstätten, Brandenburg, Germany

Median Klinik Grünheide

Grünheide, Brandenburg, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Charité Campus Benjamin Franklin

Berlin, Germany

Outcomes

Primary Outcomes

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)

Time frame: 3 months post stroke vs baseline

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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