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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00018421
Other study ID # CADE-RA
Secondary ID
Status Completed
Phase N/A
First received July 3, 2001
Last updated January 20, 2009
Start date July 1997
Est. completion date June 2001

Study information

Verified date December 2004
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This randomized trial investigates the hypothesis that regular aerobic exercise training using a task specific gait training modality will improve cardiovascular fitness, functional mobility, and reduce risk factors for recurrent cardiovascular events in chronic hemiparetic stroke patients, when compared to matched controls performing just stretching.


Description:

The aims are to determine whether 6 months progressive graded treadmill training: 1) improves cardiovascular fitness levels and reduces the excessive energy demands of hemiparetic gait, as defined by oxygen consumption levels based on open circuit spirometry during peak and submaximal exercise ambulation tasks; 2) increases free living physical activity measured by portable kinematic recording devices and quantitative in vivo determination of energy expenditure using stable isotopes; and, 3) improves the cardiovascular-metabolic risk factor profile including measures of key endogenous fibrinolysis regulatory enzymes [plasma tissue plasminogen activator (t-PA) and its main circulating inhibitor (PAI-1)], fasting lipoprotein lipid profiles, blood pressure, and oral glucose tolerance and insulin responses. Measurements of body composition at baseline and after training will further determine the effects of aerobic exercise training on muscle mass and central obesity.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Males or Females Ages 40 yrs to 80 yrs who are chronic hemiparetic stroke patients.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Intervention

Procedure:
Treadmill Exercise


Locations

Country Name City State
United States VA Maryland Health Care System Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

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