Table 1 Inclusion and exclusion criteria of Physical fitness training in Subacute Stroke (PHYS-STROKE) study

1.

Diagnosis of stroke (within 5–45 days after stroke); ischaemic or haemorrhagic (cortical, subcortical, brainstem), as determined by initial MRI/CT scan of the brain)

2.

Age ≥18 years

3.

Able to sit for at least 30 seconds (unsupported or supported - that is, holding onto supports such as the edge of the bed)

4.

Barthel Index ≤65 at inclusion

5.

Considered able to perform aerobic exercise, as determined by responsible physician

6.

Provision of written informed consent

Exclusion criteria

1.

Patient considered unable to comply with study requirements

2.

Stroke due to intracranial haemorrhage primarily due to bleeding from ruptured aneurysm or arteriovenous malformation

3.

Progressive stroke

4.

Unable to perform the required exercises due to a) medical, b) musculo-skeletal, or c) neurological problems (for details see below, 4a-c)

4a.

medical problems: unstable cardiovascular condition, or other serious cardiac conditions (for example, anyone meeting New York Heart Association Class IV criteria, hospitalisation for myocardial infarction or heart surgery within 120 days, severe cardiomyopathy or documented serious and unstable cardiac arrhythmias)

4b.

musculo-skeletal problems: restricted passive range of motion in the major lower limb joints (that is, an extension deficit of >20° for the affected hip or knee joints, or a dorsiflexion deficit of >20° for the affected ankle)

4c.

neurological problems: severity of stroke-related deficits

5.

Required help of at least 1 person to walk before stroke due to neurological (for example, advanced Parkinson’s disease, amyotrophic lateral sclerosis, multiple sclerosis) or non-neurological (for example, heart failure, orthopaedic problems) co-morbidities

6.

With life expectancy of less than 1 year as determined by responsible physician

7.

Drug or alcohol addiction within the last 6 months

8.

Significant current psychiatric illness defined as affective disorder unresponsive to medication or bipolar affective disorder, psychosis, schizophrenia or suicidality

9.

Current participation in another interventional trial