StrokeNCT01107210
Evaluation of Physical Fitness After Stroke
An observational study of Stroke, run by KU Leuven at 1 site in Belgium.
Trial summary
This study aims to examine the evolution and determinants of physical fitness after stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- May 2006to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with a first ever stroke
Who may be able to join
- first-ever stroke as defined by WHO
- aged < 75 years,
- able to comprehend simple oral instructions.
Who cannot join
- other neurological impairments with permanent damage
- stroke-like symptoms due to subdural haematoma, tumour, encephalitis or trauma
- pre-stroke Barthel Index <50
- unable to perform a maximal exercise test in accordance with absolute contra-indications for exercise testing (ACC/AHA)
- no informed consent.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital Leuven, Rehabilitation Centre Pellenberg
Pellenberg, 3212
About this study
Official title: Evaluation of Physical Fitness After Stroke: Evolution and Determinants
This study aims to examine the evolution and determinants of physical fitness after stroke.
Read the 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.
- Conditions
- Stroke
- Keywords
- stroke, physical fitness, evolution, determinants
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | 50 patients recruited in the stroke rehabilitation unit in the University Hospital, Leuven, Belgium will be included |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1y follow-up
Secondary outcomes (1)
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.
Measured: 1y follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- National Association for Support to Persons with a Disability NVSG, Van Goethem-Brichant foundation
- Investigators
- Ilse Baert, Msc, PT, Principal investigator, KU-Leuven, Faculty of Movement and Rehabilitation SciencesYves Vanlandewijck, PhD, Study chair, KU-Leuven, Faculty of Movement and Rehabilitation SciencesDaniel Daly, PhD, Study chair, KU-Leuven, Faculty of Movement and Rehabilitation SciencesHilde Feys, PhD, Study chair, KU-Leuven, Faculty of Movement and Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107210
- Sponsor's protocol ID
- ML3617
- Status last verified
- Apr 2010
- First submitted
- 13 Apr 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Fitness After Stroke: Evolution and Determinants
- ClinicalTrials.gov ID
- NCT01107210
- Acronym / sponsor ID
- ML3617
- Conditions
- Stroke
- Keywords
- stroke, physical fitness, evolution, determinants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- National Association for Support to Persons with a Disability NVSG, Van Goethem-Brichant foundation
- Study start
- May 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients | – | –50 patients recruited in the stroke rehabilitation unit in the University Hospital, Leuven, Belgium will be included |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with a first ever stroke
Key inclusion criteria (3 listed)
- first-ever stroke as defined by WHO
- aged < 75 years,
- able to comprehend simple oral instructions.
Key exclusion criteria (5 listed)
- other neurological impairments with permanent damage
- stroke-like symptoms due to subdural haematoma, tumour, encephalitis or trauma
- pre-stroke Barthel Index <50
- unable to perform a maximal exercise test in accordance with absolute contra-indications for exercise testing (ACC/AHA)
- no informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Determinants at functional, activity and participation level of physical fitness after stroke
Time frame: 1y follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilse Baert, Msc, PT principal investigator
KU-Leuven, Faculty of Movement and Rehabilitation Sciences
Yves Vanlandewijck, PhD study chair
KU-Leuven, Faculty of Movement and Rehabilitation Sciences
Daniel Daly, PhD study chair
KU-Leuven, Faculty of Movement and Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of physical fitness after stroke, measured by VO2 peak and OUES. (time frame: 1y follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.