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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Hillel Yaffe Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Zinman College of Physical Education and Sports Sciences
Israel Sport Center for the Disabled
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01396746
First received: June 28, 2011
Last updated: July 17, 2011
Last verified: July 2011
  Purpose

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.


Condition
Stroke
Hemiplegia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests in Persons With Post Stroke Conditions

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Exercise VO2 [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Exercise HR [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Mechanical efficiency [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Time for-Up-and-go (TUG) Test [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Time for 10 m walk test [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Distance for 6 min walk test [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2011
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396746

Contacts
Contact: Galia Modai 972-54-6477737 galiamodai@gmail.com

Locations
Israel
Israel Sport Center for the Disabled Recruiting
Ramat Gan, Israel
Contact: Yeshayahu Hutzler, Dr.         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Zinman College of Physical Education and Sports Sciences
Israel Sport Center for the Disabled
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
  More Information

Publications:

Responsible Party: Dr. Avraham Katz, Israel Sport Center for the Disabled
ClinicalTrials.gov Identifier: NCT01396746     History of Changes
Other Study ID Numbers: 54-2011
Study First Received: June 28, 2011
Last Updated: July 17, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hemiplegia
Stroke
Cerebral Infarction
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014