Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests After Stroke
NCT ID: NCT01396746
Last Updated: 2011-07-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
30 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-06-30
Brief Summary
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The purpose of this study is to explore the relationship between cardiovascular function of persons with post stroke conditions and their performance in three field tests. This is a validation study, aiming to determine during which of two activities VO2 measurements better express the functional restrictions caused by stroke, And to find out whether the Total Heart Beat Index can be used in the case of stroke survivors for the prediction of mechanical efficiency when measured during stair-climbing and of energy cost during treadmill walking.
The hypothesis is that Stair Climbing (STC) is a more suitable form of exercise capacity testing compared to Treadmill Walk (TMW) since it potentially requires a greater amount of external work, and therefore will show stronger correlation with functional tests demonstrating the same ability, whereas TMW does not utilize the movement capability of participants to the fullest.
Another hypothesis is that cardiac response to the exertion can be used as a predictor of those measures during these exertions in the post stroke population.
The hypothesis is that Stair Climbing (STC) is a more suitable form of exercise capacity testing compared to Treadmill Walk (TMW) since it potentially requires a greater amount of external work, and therefore will show stronger correlation with functional tests demonstrating the same ability, whereas TMW does not utilize the movement capability of participants to the fullest.
Another hypothesis is that cardiac response to the exertion can be used as a predictor of those measures during these exertions in the post stroke population.
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Detailed Description
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Conditions
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Stroke
Hemiplegia
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
CROSS_SECTIONAL
Study Groups
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People with Post Stroke Conditions
(a) having acquired stroke at least 1 year before testing. (b) Chronic weakness and/or spasticity of the affected side. (c) Independent stair-climbers (with hand-rail). (d) With cognitive level sufficient to comprehend instructions. (e) age range between 40-69. (f) Use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail. (g) No heart failure or other medical conditions that preclude participation in the study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Having acquired stroke at least 1 year before testing
* Chronic weakness and/or spasticity of the affected side
* Independent stair-climbers (with hand-rail)
* Received medical clearance from a physician
* With cognitive level sufficient to comprehend instructions
* Participants' age will range between 40-69
* Use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail.
* Chronic weakness and/or spasticity of the affected side
* Independent stair-climbers (with hand-rail)
* Received medical clearance from a physician
* With cognitive level sufficient to comprehend instructions
* Participants' age will range between 40-69
* Use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail.
Exclusion Criteria
* Unable to understand instructions
* Unable to ambulate
* Severe aphasia
* Heart failure or other medical conditions that preclude participation in the study.
* Unable to ambulate
* Severe aphasia
* Heart failure or other medical conditions that preclude participation in the study.
Minimum Eligible Age
40 Years
Maximum Eligible Age
69 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Zinman College of Physical Education and Sports Sciences
OTHER
Sponsor Role
collaborator
Israel Sport Center for the Disabled
OTHER
Sponsor Role
collaborator
Hillel Yaffe Medical Center
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Israel Sport Center for the Disabled
Principal Investigators
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Yeshayahu Hutzler, Dr.
Role: STUDY_CHAIR
The Wingate institute for physical education and sports
Avraham Katz, MD
Role: PRINCIPAL_INVESTIGATOR
Israel Sport Center for the Disabled
Galia Modai
Role: STUDY_DIRECTOR
The Wingate Institute for Physical Education and Sports
Locations
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Israel Sport Center for the Disabled
Ramat Gan, , Israel
Site Status
RECRUITING
Countries
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Israel
Central Contacts
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Facility Contacts
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Yeshayahu Hutzler, Dr.
Role: primary
References
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Other Identifiers
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54-2011
Identifier Type: -
Identifier Source: org_study_id
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