- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01436630
Step Test and Six Minute Walk Test in Stroke
Comparação Entre o Teste de Caminhada de Seis Minutos e o Teste do Degrau de Seis Minutos em Pacientes Com Acidente Vascular Encefálico
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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São Paulo, Brazil
- Faculdades Metropolitanas Unidas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- To be able to walk alone without supervision and with no aids.
Exclusion Criteria:
- There were no.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stroke
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. All the patients signed an informed consent before performing the tests. To characterize the sample it were used the Fugl-Meyer scale, Orpington test, Mini Exam of the Mental State and some other data regarding the age, gender, type of the lesion and side of the lesion. |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiological Variables
Time Frame: 6 months
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Will be assessed Blood Pressure (BP), Heart Rate (HR), Breathing, Feeling of fatigue and dyspnea with the Borg scale, and the Double Product.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance
Time Frame: 6 months
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Will be evaluated through the correlation between the number of ascents on the step and the distance covered in walking test.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rodrigo Daminello Raimundo, Professor, Faculdades Metropolitanas Unidas
- Study Director: Camila Torriani-Pasin, Professor, University of Sao Paulo
- Study Director: Carlos Bandeira de Mello Monteiro, Professor, University of Sao Paulo
- Study Director: Osmar Aparecido Theodoro Junior, Professor, Faculdades Metropolitanas Unidas
- Study Chair: Talita Dias da Silva, Physiotherap, Faculdades Metropolitanas Unidas
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDS-2809
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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