Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Charité University Medicine Berlin

Status and phase

Completed

Phase 3

Conditions

Stroke

Treatments

Procedure: relaxation

Procedure: physical fitness training

Study type

Interventional

Funder types

Other

Identifiers

NCT01953549

PHYS-Stroke

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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