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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 14, 2010
April 1, 2010
10 months
February 16, 2010
April 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
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.
Study Arms (5)
Control group
PLACEBO COMPARATORThe 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.
Aerobic exercise group
EXPERIMENTALThe 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.
Follow-up first aerobic exercise group
EXPERIMENTALFollow-up control group
PLACEBO COMPARATORFollow-up second aerobic exercise group
EXPERIMENTALInterventions
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.
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 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.
No intervention will be offered in a period of 9 months after the passive mobilisation programme
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College of Antwerplead
- Universiteit Antwerpencollaborator
- KU Leuvencollaborator
- University Hospital, Antwerpcollaborator
Study Sites (1)
Revalidatiecentrum Sint-Ursula
Herk-de-Stad, Limburg, 3540, Belgium
Related Publications (3)
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.
PMID: 34184251DERIVEDVanroy 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.
PMID: 29105516DERIVEDVanroy 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.
PMID: 28284834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 18, 2010
Study Start
February 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
April 14, 2010
Record last verified: 2010-04