Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests After Stroke

Stroke Clinical Trial

Official title:

Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests in Persons With Post Stroke Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01396746
• Other study ID #: 54-2011
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2011
• Last updated: July 17, 2011
• Start date: June 2011

Study information

• Verified date: July 2011
• Source: Hillel Yaffe Medical Center
• Contact: Galia Modai
• Phone: 972-54-6477737
• Email: galiamodai[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 69 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Locations

Country	Name	City	State
Israel	Israel Sport Center for the Disabled	Ramat Gan

Sponsors (3)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center	Israel Sport Center for the Disabled, Zinman College of Physical Education and Sports Sciences

Country where clinical trial is conducted

Israel, 

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise VO2		60 days	No
Primary	Exercise HR		60 days	No
Primary	Mechanical efficiency		60 days	No
Primary	Time for-Up-and-go (TUG) Test		60 days	No
Primary	Time for 10 m walk test		60 days	No
Primary	Distance for 6 min walk test		60 days	No