The Effect of an Aerobic Exercise Programme in Stroke Patients

Cerebrovascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01070459
• Other study ID #: B30020107752
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: February 16, 2010
• Last updated: April 13, 2010
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2010
• Source: University College of Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• Aerobic exercise group
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.
• Control 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.
• Follow-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.
• Follow-up control group
No intervention will be offered in a period of 9 months after the passive mobilisation programme
• Follow-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

Locations

Country	Name	City	State
Belgium	Revalidatiecentrum Sint-Ursula	Herk-de-Stad	Limburg

Sponsors (4)

Lead Sponsor	Collaborator
University College of Antwerp	Katholieke Universiteit Leuven, Universiteit Antwerpen, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No