Clinical trial NCT01396746: Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests After Stroke
Official title: Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests in Persons With Post Stroke Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Hemiplegia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Zinman College of Physical Education and Sports Sciences
name: Israel Sport Center for the Disabled
First posted: 2011-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are recruited in community centers designated for Disabled populations. They are leading a physically active life style, usually facilitated by an assistant.

Brief summary: 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.


Eligibility criteria: 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.

Exclusion Criteria:

* Unable to understand instructions
* Unable to ambulate
* Severe aphasia
* Heart failure or other medical conditions that preclude participation in the study.

Primary outcomes:
measure: Exercise VO2
timeFrame: 60 days
measure: Exercise HR
timeFrame: 60 days
measure: Mechanical efficiency
timeFrame: 60 days
measure: Time for-Up-and-go (TUG) Test
timeFrame: 60 days
measure: Time for 10 m walk test
timeFrame: 60 days
measure: Distance for 6 min walk test
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Israel Sport Center for the Disabled
Study officials:
affiliation: The Wingate institute for physical education and sports
name: Yeshayahu Hutzler, Dr.
role: STUDY_CHAIR
affiliation: Israel Sport Center for the Disabled
name: Avraham Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Wingate Institute for Physical Education and Sports
name: Galia Modai
role: STUDY_DIRECTOR
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