Clinical trial NCT01070459: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cerebrovascular Accident
Keywords: Stroke aerobic exercise daily functioning rehabilitation
Lead sponsor: University College of Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: KU Leuven
name: University Hospital, Antwerp
First posted: 2010-02-18
Enrollment: 50
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: VO2-peak, strength, walking, activities of daily living
timeFrame: baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.
Secondary outcomes:
measure: post-stroke fatigue, depression, lifestyle, cardiovascular risk factors
timeFrame: baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.
Other outcomes:
Locations:
city: Herk-de-Stad
country: Belgium
facility: Revalidatiecentrum Sint-Ursula
state: Limburg
Study officials:
affiliation: Universiteit Antwerpen
name: Patrick Cras, prof. dr.
role: STUDY_CHAIR
affiliation: KU Leuven
name: Yves Vanlandewijck, prof.dr.
role: STUDY_DIRECTOR
affiliation: Catholic University of Antwerp
name: Hilde Feys, prof.dr.
role: STUDY_DIRECTOR
affiliation: University college Antwerp
name: Steven Truijen, dr.
role: STUDY_DIRECTOR
affiliation: University College of Antwerp
name: Dirk Vissers, dr.
role: STUDY_DIRECTOR
affiliation: University College Antwerp
name: christel Vanroy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.