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The Effect of an Aerobic Exercise Programme in Stroke Patients

The Effect of an Aerobic Training Programme on the Aerobic Capacity, Functional Behavior and the Cardiovascular Risk Factors in Stroke Patients

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01070459
Enrollment
50
Registered
2010-02-18
Start date
2010-02-28
Completion date
2011-12-31
Last updated
2010-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident

Keywords

Stroke aerobic exercise daily functioning rehabilitation

Brief summary

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.

Detailed 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.

Interventions

The patients continue 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 heartrate 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 exercise programme four information sessions will be offered to patients and relatives about risk factors of stroke, usefulness of an active lifestyle and healthy eating.

BEHAVIORALControl group

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.

BEHAVIORALFollow-up first aerobic exercise group

The experimental aerobic exercise will be divided in two groups at random after the 12 weeks aerobic exercise programme. The first group will get feedback on how to train further their aerobic capacity within the following 9 months. The second group will not undergo the feedback programme.

BEHAVIORALFollow-up control group

No intervention will be offered in a period of 9 months after the passive mobilisation programme

BEHAVIORALFollow-up second aerobic exercise group

The experimental aerobic exercise will be divided in two groups at random after the 12 weeks aerobic exercise programme. The second group will not undergo the feedback programme. This group will be measured but not treated with an intervention programme

Sponsors

Universiteit Antwerpen
CollaboratorOTHER
KU Leuven
CollaboratorOTHER
University Hospital, Antwerp
CollaboratorOTHER
University College of Antwerp
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
VO2-peak, strength, walking, activities of daily livingbaseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.

Secondary

MeasureTime frame
post-stroke fatigue, depression, lifestyle, cardiovascular risk factorsbaseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026