Evaluation of Physical Fitness After Stroke

Stroke Clinical Trial

Official title:

Evaluation of Physical Fitness After Stroke: Evolution and Determinants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107210
• Other study ID #: ML3617
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: June 22, 2011
• Start date: May 2006
• Est. completion date: September 2010

Study information

• Verified date: April 2010
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Belgium	University Hospital Leuven, Rehabilitation Centre Pellenberg	Pellenberg

Sponsors (3)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	National Association for Support to Persons with a Disability NVSG, Van Goethem-Brichant foundation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No