Evaluation of Physical Fitness After Stroke

This study has been completed.
Sponsor:
Collaborators:
National Association for Support to Persons with a Disability NVSG
Van Goethem-Brichant foundation
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01107210
First received: April 13, 2010
Last updated: June 22, 2011
Last verified: April 2010
  Purpose

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


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Physical Fitness After Stroke: Evolution and Determinants

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Evolution of physical fitness after stroke, measured by VO2 peak and OUES. [ Time Frame: 1y follow-up ] [ Designated as safety issue: No ]
    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:
  • Determinants at functional, activity and participation level of physical fitness after stroke [ Time Frame: 1y follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: May 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
stroke patients
50 patients recruited in the stroke rehabilitation unit in the University Hospital, Leuven, Belgium will be included

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ilse Baert, KULeuven
ClinicalTrials.gov Identifier: NCT01107210     History of Changes
Other Study ID Numbers: ML3617
Study First Received: April 13, 2010
Last Updated: June 22, 2011
Health Authority: Belgium: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014