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The Effect of an Aerobic Exercise Programme in Stroke Patients

Primary Purpose

Cerebrovascular Accident

Status
Unknown status
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Aerobic exercise group
Control group
Follow-up first aerobic exercise group
Follow-up control group
Follow-up second aerobic exercise group
Sponsored by
University College of Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Stroke aerobic exercise daily functioning rehabilitation

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Revalidatiecentrum Sint-Ursula

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Control group

Aerobic exercise group

Follow-up first aerobic exercise group

Follow-up control group

Follow-up second aerobic exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

VO2-peak, strength, walking, activities of daily living

Secondary Outcome Measures

post-stroke fatigue, depression, lifestyle, cardiovascular risk factors

Full Information

First Posted
February 16, 2010
Last Updated
April 13, 2010
Sponsor
University College of Antwerp
Collaborators
Universiteit Antwerpen, KU Leuven, University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT01070459
Brief Title
The Effect of an Aerobic Exercise Programme in Stroke Patients
Official Title
The Effect of an Aerobic Training Programme on the Aerobic Capacity, Functional Behavior and the Cardiovascular Risk Factors in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University College of Antwerp
Collaborators
Universiteit Antwerpen, KU Leuven, University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Stroke aerobic exercise daily functioning rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Aerobic exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Follow-up first aerobic exercise group
Arm Type
Experimental
Arm Title
Follow-up control group
Arm Type
Placebo Comparator
Arm Title
Follow-up second aerobic exercise group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Follow-up first aerobic exercise group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Follow-up control group
Intervention Description
No intervention will be offered in a period of 9 months after the passive mobilisation programme
Intervention Type
Behavioral
Intervention Name(s)
Follow-up second aerobic exercise group
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Cras, prof. dr.
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yves Vanlandewijck, prof.dr.
Organizational Affiliation
KU Leuven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hilde Feys, prof.dr.
Organizational Affiliation
Catholic University of Antwerp
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steven Truijen, dr.
Organizational Affiliation
University college Antwerp
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dirk Vissers, dr.
Organizational Affiliation
University College of Antwerp
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
christel Vanroy, PhD
Organizational Affiliation
University College Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Revalidatiecentrum Sint-Ursula
City
Herk-de-Stad
State/Province
Limburg
ZIP/Postal Code
3540
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
34184251
Citation
Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
Results Reference
derived
PubMed Identifier
29105516
Citation
Vanroy C, Vanlandewijck Y, Cras P, Truijen S, Vissers D, Swinnen A, Bosmans M, Wouters K, Feys H. Does a cycling program combined with education and followed by coaching promote physical activity in subacute stroke patients? A randomized controlled trial. Disabil Rehabil. 2019 Feb;41(4):413-421. doi: 10.1080/09638288.2017.1395084. Epub 2017 Nov 5.
Results Reference
derived
PubMed Identifier
28284834
Citation
Vanroy C, Feys H, Swinnen A, Vanlandewijck Y, Truijen S, Vissers D, Michielsen M, Wouters K, Cras P. Effectiveness of Active Cycling in Subacute Stroke Rehabilitation: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1576-1585.e5. doi: 10.1016/j.apmr.2017.02.004. Epub 2017 Mar 8.
Results Reference
derived

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The Effect of an Aerobic Exercise Programme in Stroke Patients

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