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Evaluation of Physical Fitness After Stroke

Evaluation of Physical Fitness After Stroke: Evolution and Determinants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01107210
Enrollment
50
Registered
2010-04-20
Start date
2006-05-31
Completion date
2010-09-30
Last updated
2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, physical fitness, evolution, determinants

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.

Interventions

None listed

Sponsors

National Association for Support to Persons with a Disability NVSG
CollaboratorUNKNOWN
Van Goethem-Brichant foundation
CollaboratorUNKNOWN
KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evolution of physical fitness after stroke, measured by VO2 peak and OUES.1y follow-upThe 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

MeasureTime frameDescription
Determinants at functional, activity and participation level of physical fitness after stroke1y follow-upTo 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026