Clinical trial NCT01107210: Evaluation of Physical Fitness After Stroke
Official title: Evaluation of Physical Fitness After Stroke: Evolution and Determinants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
physical fitness
evolution
determinants
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: National Association for Support to Persons with a Disability NVSG
name: Van Goethem-Brichant foundation
First posted: 2010-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with a first ever stroke

Brief summary: This study aims to examine the evolution and determinants of physical fitness after stroke.

Detailed description: Stroke is a major cause of chronic severe disability. More than 50% of stroke survivors have residual motor and functional deficits which have an impact on their participation and quality of live (Patel et al, 2006). Limitations on daily functioning may lead to physical inactivity and a sedentary lifestyle. Sustained physical inactivity (deconditioning) induces a reduction in aerobic capacity, which may further increase the risk of cardiovascular diseases in these individuals above that associated with stroke itself. Therefore, improving aerobic capacity may be essential in prevention of secondary diseases due to lack of fitness in the stroke population. Previous studies have also indicated that a critical level of aerobic capacity must be met in order to function independently (Cress et al, 2003). Therefore, in addition to disease prevention, enhancing aerobic capacity in individuals with stroke may also have beneficial effects on promoting functional abilities and independent living. It is also known that a limitation in functional performance is mostly associated with a restriction in social activities (ICIDH-2-model). Clearly, stroke survivors can benefit from counseling on participation in physical activity and exercise training. A recent meta-analysis (Pang et al, 2006) showed that there is good evidence to support the use of aerobic exercise to improve aerobic capacity in individuals with stroke. However, before going on that road, one needs to know more about the level of physical activity and physical fitness in the stroke population.

Eligibility criteria: Inclusion Criteria:

1. first-ever stroke as defined by WHO
2. aged \< 75 years,
3. able to comprehend simple oral instructions.

Exclusion Criteria:

1. other neurological impairments with permanent damage
2. stroke-like symptoms due to subdural haematoma, tumour, encephalitis or trauma
3. pre-stroke Barthel Index \<50
4. unable to perform a maximal exercise test in accordance with absolute contra-indications for exercise testing (ACC/AHA)
5. no informed consent.

Primary outcomes:
measure: Evolution of physical fitness after stroke, measured by VO2 peak and OUES.
timeFrame: 1y follow-up
Secondary outcomes:
measure: Determinants at functional, activity and participation level of physical fitness after stroke
timeFrame: 1y follow-up
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: University Hospital Leuven, Rehabilitation Centre Pellenberg
Study officials:
affiliation: KU-Leuven, Faculty of Movement and Rehabilitation Sciences
name: Ilse Baert, Msc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: KU-Leuven, Faculty of Movement and Rehabilitation Sciences
name: Yves Vanlandewijck, PhD
role: STUDY_CHAIR
affiliation: KU-Leuven, Faculty of Movement and Rehabilitation Sciences
name: Daniel Daly, PhD
role: STUDY_CHAIR
affiliation: KU-Leuven, Faculty of Movement and Rehabilitation Sciences
name: Hilde Feys, PhD
role: STUDY_CHAIR
References: