The Effect of an Aerobic Exercise Programme in Stroke Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Universiteit Antwerpen
Katholieke Universiteit Leuven
University Hospital, Antwerp
Information provided by:
University College of Antwerp
ClinicalTrials.gov Identifier:
NCT01070459
First received: February 16, 2010
Last updated: April 13, 2010
Last verified: April 2010

February 16, 2010
April 13, 2010
February 2010
December 2010   (final data collection date for primary outcome measure)
VO2-peak, strength, walking, activities of daily living [ Time Frame: baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01070459 on ClinicalTrials.gov Archive Site
post-stroke fatigue, depression, lifestyle, cardiovascular risk factors [ Time Frame: baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cerebrovascular Accident
  • 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.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: Follow-up control group
    No intervention will be offered in a period of 9 months after the passive mobilisation programme
  • Behavioral: 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
  • Placebo Comparator: 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.
    Intervention: Behavioral: Follow-up control group
  • Experimental: Aerobic exercise group
    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.
    Interventions:
    • Behavioral: Aerobic exercise group
    • Behavioral: Follow-up first aerobic exercise group
    • Behavioral: Follow-up second aerobic exercise group
  • Experimental: Follow-up first aerobic exercise group
    Intervention: Behavioral: Follow-up first aerobic exercise group
  • Placebo Comparator: Follow-up control group
    Interventions:
    • Behavioral: Control group
    • Behavioral: Follow-up control group
  • Experimental: Follow-up second aerobic exercise group
    Intervention: Behavioral: Follow-up second aerobic exercise group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
December 2011
December 2010   (final data collection date for primary outcome measure)

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)
Both
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01070459
B30020107752
Yes
University College of Antwerp, Campus HIKE Merksem
University College of Antwerp
  • Universiteit Antwerpen
  • Katholieke Universiteit Leuven
  • University Hospital, Antwerp
Study Chair: Patrick Cras, prof. dr. Universiteit Antwerpen
Study Director: Yves Vanlandewijck, prof.dr. Katholieke Universiteit Leuven
Study Director: Hilde Feys, prof.dr. Catholic University of Antwerp
Study Director: Steven Truijen, dr. University college Antwerp
Study Director: Dirk Vissers, dr. University College of Antwerp
Principal Investigator: christel Vanroy, PhD University College Antwerp
University College of Antwerp
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP