Evaluation of Physical Fitness After Stroke

Evaluation of Physical Fitness After Stroke: Evolution and Determinants

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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Belgium
  • Pellenberg, Belgium, 3212
    • University Hospital Leuven, Rehabilitation Centre Pellenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects with a first ever stroke

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1y follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1y follow-up

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Estimate): June 23, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: stroke; physical fitness; evolution; determinants
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ML3617