The Effect of an Aerobic Exercise Programme in Stroke Patients

University College of Antwerp

Status and phase

Unknown

Phase 3

Conditions

Cerebrovascular Accident

Treatments

Behavioral: Follow-up first aerobic exercise group

Behavioral: Control group

Behavioral: Aerobic exercise group

Behavioral: Follow-up second aerobic exercise group

Behavioral: Follow-up control group

Study type

Interventional

Funder types

Other

Identifiers

NCT01070459

B30020107752

Details and patient eligibility

About

This study aims to investigate the effect of aerobic exercise on the aerobic capacity, the daily functioning, post-stroke fatigue , depression and cardiovascular risk factors in stroke patients.

Full description

People with neurologic impairments after stroke often show decreased aerobic exercise capacity. The etiologies of which are assigned to physiologic changes in paretic muscle, gait deficits and disability-related deconditioning. This declares that stroke patients live an inactive lifestyle and therefore stay cardiovascular risk patients.

The usefulness of aerobic training on aerobic capacity is recently been proved in clinical stroke research. However, no study can shown the long-term effect of aerobic exercises. Also the effect of aerobic exercises on daily functioning, fatigue and depression in stroke needs to be established.

Enrollment

50 patients

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

First CVA according to the WHO definition (A primary, first ever stroke ash revealed by rapidly developing clinical signs or focal or global disturbance or cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than or vascular origin.) This includes ischemic infarct or an intracerebral haemorrhage
The offense can be maximum 3 up to 6 weeks after onset
Patient must be able to follow simple verbal instructions
To cycle during 1 minute at 20 Watt, 50RPM,
Cardiac stable

Exclusion criteria

Have another neurological impairments with permanent damage such as former cranial trauma, multiple sclerosis, epileptic status... which already present were for current CVA
Having on CVA resembling symptoms as a result of subdural haemorrhage, a tumour, encephalitis or a trauma
Barthel index < 50 before the stroke onset
Age > 80 year
No authorisation form of the patient or of the family
Absolute contra-indications for effort test (ACC/AHA guidelines)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 5 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

The patients continue their regular therapy in the rehabilitation center. They participate in a 12-week programme of passive mobilisation of the hemiplegic knee, using a continuous passive motion device. Patients will be trained three times a week, 30 minutes/session.

Treatment:

Behavioral: Follow-up control group

Aerobic exercise group

Experimental group

Description:

The patients continues their regular therapy in the rehabilitation center. They participate in a 12-week programme of aerobic training 30 minutes/session, using a leg cycle bike. Patients will be trained three times a week. The heart rate will vary from 50 tot 75% of their predicted heart rate. Each patient will be provided with an progressive exercise prescription based on 50-75% of their predicted maximum heartrate. Throughout the training sessions the heart rate will be monitored continuously with a polar pulse rate. Within these 12 week training programme 4 information sessions will be offered to patients and relatives about risk factors of stroke, usefulness of an active lifestyle and healthy eating.

Treatment:

Behavioral: Follow-up first aerobic exercise group

Behavioral: Follow-up second aerobic exercise group

Behavioral: Aerobic exercise group

Follow-up first aerobic exercise group

Experimental group

Treatment:

Behavioral: Follow-up first aerobic exercise group

Follow-up control group

Placebo Comparator group

Treatment:

Behavioral: Follow-up control group