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

July 17, 2011 updated by: Hillel Yaffe Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ramat Gan, Israel
        • Recruiting
        • Israel Sport Center for the Disabled
        • Contact:
          • Yeshayahu Hutzler, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise VO2
Time Frame: 60 days
60 days
Exercise HR
Time Frame: 60 days
60 days
Mechanical efficiency
Time Frame: 60 days
60 days
Time for-Up-and-go (TUG) Test
Time Frame: 60 days
60 days
Time for 10 m walk test
Time Frame: 60 days
60 days
Distance for 6 min walk test
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Yeshayahu Hutzler, Dr., The Wingate Institute for Physical Education and Sports
  • Principal Investigator: Avraham Katz, MD, Israel Sport Center for the Disabled
  • Study Director: Galia Modai, The Wingate Institute for Physical Education and Sports

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

July 17, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

July 19, 2011

Last Update Submitted That Met QC Criteria

July 17, 2011

Last Verified

July 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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