Evaluation of Physical Fitness After Stroke
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|ClinicalTrials.gov Identifier: NCT01107210|
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : June 23, 2011
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Evaluation of Physical Fitness After Stroke: Evolution and Determinants|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
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. [ Time Frame: 1y follow-up ]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.
- Determinants at functional, activity and participation level of physical fitness after stroke [ Time Frame: 1y follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107210
|University Hospital Leuven, Rehabilitation Centre Pellenberg|
|Pellenberg, Belgium, 3212|
|Principal Investigator:||Ilse Baert, Msc, PT||KU-Leuven, Faculty of Movement and Rehabilitation Sciences|
|Study Chair:||Yves Vanlandewijck, PhD||KU-Leuven, Faculty of Movement and Rehabilitation Sciences|
|Study Chair:||Daniel Daly, PhD||KU-Leuven, Faculty of Movement and Rehabilitation Sciences|
|Study Chair:||Hilde Feys, PhD||KU-Leuven, Faculty of Movement and Rehabilitation Sciences|