The Effect of an Aerobic Exercise Programme in Stroke Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Behavioral: Aerobic exercise group
* Behavioral: Control group
* Behavioral: Follow-up first aerobic exercise group
* Behavioral: Follow-up control group
* Behavioral: Follow-up second aerobic exercise group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>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. | Behavioral: Follow-up control group<br>* No intervention will be offered in a period of 9 months after the passive mobilisation programme<br>|
| Experimental: Aerobic exercise group<br>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. | Behavioral: Aerobic exercise group<br>* 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.<br>Behavioral: Follow-up first aerobic exercise group<br>* 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.<br>Behavioral: Follow-up second aerobic exercise group<br>* 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<br>|
| Experimental: Follow-up first aerobic exercise group<br> | Behavioral: Follow-up first aerobic exercise group<br>* 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.<br>|
| Placebo Comparator: Follow-up control group<br> | Behavioral: Control group<br>* 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.<br>Behavioral: Follow-up control group<br>* No intervention will be offered in a period of 9 months after the passive mobilisation programme<br>|
| Experimental: Follow-up second aerobic exercise group<br> | Behavioral: Follow-up second aerobic exercise group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2-peak, strength, walking, activities of daily living |  | baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-stroke fatigue, depression, lifestyle, cardiovascular risk factors |  | baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke aerobic exercise daily functioning rehabilitation