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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01436630
Other study ID # TDS-2809
Secondary ID
Status Completed
Phase N/A
First received September 16, 2011
Last updated September 19, 2011
Start date February 2010
Est. completion date December 2010

Study information

Verified date September 2011
Source Faculdades Metropolitanas Unidas
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate the viability of using the Step Test (ST) in stroke patients, and to compare the functional performance of the physiologic variables in stroke patients during ST and Six Minute Walk Test (6MWT).


Description:

To accomplish the study it was assessed a group of 12 post-stroke patients who were admitted in the Rehabilitation Clinic inside the University. As inclusion criteria it was established to be able to walk alone without supervision and with no aids.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- To be able to walk alone without supervision and with no aids.

Exclusion Criteria:

- There were no.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Step Test and Six Minute Walk.
The 6 Minute Walk Test (6MWT) was conducted in a level corridor 30 meters long and 5 meters wide. Before and after testing were measured O2 saturation (SatO2) and heart rate (HR), respiratory rate (RR), blood pressure (BP), the Double Product (DP), a measure of myocardial oxygen consumption, was calculated as the product of HR and systolic BP, and the sensation of dyspnea and fatigue of the lower limbs using the Borg scale, and performing the record turns traveled, each 30 meters is considered a covered back. To calculate the predicted distance, the investigators use the formula described by American Thoracic Society (ATS) knowing the weight, age and height of participants. The Step Test (ST) was conducted in six minutes for it to be compared to the 6MWT.

Locations

Country Name City State
Brazil Faculdades Metropolitanas Unidas São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Faculdades Metropolitanas Unidas

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physiological Variables Will be assessed Blood Pressure (BP), Heart Rate (HR), Breathing, Feeling of fatigue and dyspnea with the Borg scale, and the Double Product. 6 months Yes
Secondary Performance Will be evaluated through the correlation between the number of ascents on the step and the distance covered in walking test. 6 months Yes
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