StrokeNCT01436630
Step Test and Six Minute Walk Test in Stroke
An observational study of Stroke, run by Faculdades Metropolitanas Unidas at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Step Test and Six Minute Walk.
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post-stroke patients
Who may be able to join
- To be able to walk alone without supervision and with no aids.
Who cannot join
- There were no.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparação Entre o Teste de Caminhada de Seis Minutos e o Teste do Degrau de Seis Minutos em Pacientes Com Acidente Vascular Encefálico
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).
Read the detailed 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.
- Conditions
- Stroke
- Being tested
- Step Test and Six Minute Walk.
- Keywords
- Exercise Tolerance, Step Test, Stroke, Walking
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step Test and Six Minute Walk.Other
Also called Step Test, Six Minute Walk Test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Step Test and Six Minute Walk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Performance
Will be evaluated through the correlation between the number of ascents on the step and the distance covered in walking test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdades Metropolitanas Unidas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talita Dias da Silva, Faculdades Metropolitanas Unidas
- Investigators
- Rodrigo Daminello Raimundo, Professor, Principal investigator, Faculdades Metropolitanas UnidasCamila Torriani-Pasin, Professor, Study director, University of Sao PauloCarlos Bandeira de Mello Monteiro, Professor, Study director, University of Sao PauloOsmar Aparecido Theodoro Junior, Professor, Study director, Faculdades Metropolitanas UnidasTalita Dias da Silva, Physiotherap, Study chair, Faculdades Metropolitanas Unidas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436630
- Sponsor's protocol ID
- TDS-2809
- Status last verified
- Sep 2011
- First submitted
- 16 Sep 2011
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparação Entre o Teste de Caminhada de Seis Minutos e o Teste do Degrau de Seis Minutos em Pacientes Com Acidente Vascular Encefálico
- ClinicalTrials.gov ID
- NCT01436630
- Acronym / sponsor ID
- TDS-2809
- Conditions
- Stroke
- Keywords
- Exercise Tolerance, Step Test, Stroke, Walking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Faculdades Metropolitanas UnidasUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Other: Step Test and Six Minute Walk.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-stroke patients
Key inclusion criteria (1 listed)
- To be able to walk alone without supervision and with no aids.
Key exclusion criteria (1 listed)
- There were no.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step Test and Six Minute Walk.Also: Step Test, Six Minute Walk TestThe 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 | Stroke |
Primary outcome
Physiological Variables
Time frame: 6 months
Will be assessed Blood Pressure (BP), Heart Rate (HR), Breathing, Feeling of fatigue and dyspnea with the Borg scale, and the Double Product.
1 secondary outcome
Performance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Daminello Raimundo, Professor principal investigator
Faculdades Metropolitanas Unidas
Camila Torriani-Pasin, Professor study director
University of Sao Paulo
Carlos Bandeira de Mello Monteiro, Professor study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Faculdades Metropolitanas Unidas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Variables (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.