Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430456
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2007-01-31
Brief Title:
Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPs
Brief Summary:
Individuals disabled by stroke are at risk of losing cardiovascular fitness and muscle due to disease This worsens disability and can increase the risk of having another stroke or a heart attack We would like to find out if and how different types of regular exercise intense walking long walking can increase fitness balance and improve walking function and activities of daily living in individuals who have suffered a stroke
Detailed Description:
This randomized study compares effects of duration vs velocity-based TM training regimens on fitness and ambulatory function in chronic stroke patients Phase 1 - patients are screened Mini Mental Status CESD for depression alcohol intake survey and undergo routine medical and CV evaluations and blood labs in VA RRDC Assessment Clinic to establish medical eligibility Standard neurological evaluations NIH Stroke Scale Modified Asworth Spasticity Scale range of motion and manual motor testing and review of imaging records assess neurological eligibility deficit profiles and stroke subtypes Physician supervised treadmill tolerance test and peak effort constant velocity exercise stress test with vital signs monitoring determine treadmill safety functional eligibility to participate must walk 3 minutes at 02 MPH with handrail support and cardiopulmonary safety in response to strenuous exertion Eligible candidates undergo baseline testing phase 2 including measures of fitness VO2 peak gait economy ambulatory function and BOLD fMRI of knee movement Phase 3 - 6 months TM training with either velocity or duration based progression followed by Phase 4 -repeat of fitness and ambulatory function tests after 3 months and Phase 5 - repeat of all baseline tests after 6 months training
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None