An observational study in Stroke, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-06-23.
Sponsored by KU Leuven · Observational
This study aims to examine the evolution and determinants of physical fitness after stroke.
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.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's planned enrollment of 50 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →KU Leuven is the lead sponsor of 359 studies on the registry; 63 are open to participants now.
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subjects with a first ever stroke
Exclusion Criteria:
50 patients recruited in the stroke rehabilitation unit in the University Hospital, Leuven, Belgium will be included
Evolution of physical fitness after stroke, measured by VO2 peak and OUES.
The criterion standard of cardiorespiratory fitness (VO2max) will be measured during a graded cycle ergometer test. After three minutes of familiarization, the participants will begin to pedal at 10W, with workload increments of 10W/min; they will be instructed to pedal at a comfortable rate between 30 to 60 rpm. Participants will also be monitored with Borg's 16-point Ratings of Perceived Exertion Scale. Maximal effort will be achieved according the ACSM criteria. If no "true" VO2 peak value could be reached, the Oxygen Uptake Efficiency Slope (OUES)will be determined as dependent variable.
Time frame: 1y follow-up
Determinants at functional, activity and participation level of physical fitness after stroke
To explore the effect of patient's demographic characteristics and initial stroke severity on the evolution of cardiorepiratory fitness, following independent variables will be used: age, gender, BMI, pre-stroke activity level, type of stroke, NIHSS, TIS, RMA-GF, FAC, BI and MMSE. Patient's functional level (lower limb strength), activity level (TIS, RMA-GF, FAC, BI, NEADL, timed 10m test), participation level (MMSE, BDI-II, SIP 3.0, MRS); patient's body composition (BMI, skinfolds); and use of health services will be assess to identify determinants of cardiorespiratory fitness.
Time frame: 1y follow-up
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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