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
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of an Aerobic Training Programme on the Aerobic Capacity, Functional Behavior and the Cardiovascular Risk Factors in Stroke Patients

Resource links provided by NLM:


Further study details as provided by University College of Antwerp:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Follow-up control group
No intervention will be offered in a period of 9 months after the passive mobilisation programme
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.
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: 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 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
Experimental: Follow-up first aerobic exercise group 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.
Placebo Comparator: Follow-up control group 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 control group
No intervention will be offered in a period of 9 months after the passive mobilisation programme
Experimental: Follow-up second aerobic exercise group 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

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070459

Locations
Belgium
Revalidatiecentrum Sint-Ursula
Herk-de-Stad, Limburg, Belgium, 3540
Sponsors and Collaborators
University College of Antwerp
Universiteit Antwerpen
Katholieke Universiteit Leuven
University Hospital, Antwerp
Investigators
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
  More Information

No publications provided

Responsible Party: University College of Antwerp, Campus HIKE Merksem
ClinicalTrials.gov Identifier: NCT01070459     History of Changes
Other Study ID Numbers: B30020107752
Study First Received: February 16, 2010
Last Updated: April 13, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by University College of Antwerp:
Stroke aerobic exercise daily functioning rehabilitation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014