The Effect of an Aerobic Exercise Programme in Stroke Patients

April 13, 2010 updated by: University College of Antwerp

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Herk-de-Stad, Limburg, Belgium, 3540
        • Revalidatiecentrum Sint-Ursula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Follow-up control group
No intervention will be offered in a period of 9 months after the passive mobilisation programme
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College of Antwerp

Collaborators

KU Leuven
University Hospital, Antwerp
Universiteit Antwerpen

Investigators

  • Study Chair: Patrick Cras, prof. dr., Universiteit Antwerpen
  • Study Director: Yves Vanlandewijck, prof.dr., KU 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

April 14, 2010

Last Update Submitted That Met QC Criteria

April 13, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B30020107752

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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