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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
Sponsor:
Collaborators:
National Association for Support to Persons with a Disability NVSG
Van Goethem-Brichant foundation
Information provided by:
Katholieke Universiteit Leuven

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

Condition or disease
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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
stroke patients
50 patients recruited in the stroke rehabilitation unit in the University Hospital, Leuven, Belgium will be included



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects with a first ever stroke
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.

Information from the National Library of Medicine

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


Locations
Belgium
University Hospital Leuven, Rehabilitation Centre Pellenberg
Pellenberg, Belgium, 3212
Sponsors and Collaborators
Katholieke Universiteit Leuven
National Association for Support to Persons with a Disability NVSG
Van Goethem-Brichant foundation
Investigators
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

Responsible Party: Ilse Baert, KULeuven
ClinicalTrials.gov Identifier: NCT01107210     History of Changes
Other Study ID Numbers: ML3617
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: April 2010

Keywords provided by Katholieke Universiteit Leuven:
stroke
physical fitness
evolution
determinants

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases