NCT01436630

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

9 months

First QC Date

September 16, 2011

Last Update Submit

September 19, 2011

Conditions

Keywords

Exercise ToleranceStep TestStrokeWalking

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Performance

    6 months

Study Arms (1)

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.

Other: Step Test and Six Minute Walk.

Interventions

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.

Also known as: Step Test, Six Minute Walk Test
Stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Post-stroke patients

You may qualify if:

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

You may not qualify if:

  • There were no.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdades Metropolitanas Unidas

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise TestWalking

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Rodrigo Daminello Raimundo, Professor

    Faculdades Metropolitanas Unidas

    PRINCIPAL INVESTIGATOR
  • 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 DIRECTOR
  • Talita Dias da Silva, Physiotherap

    Faculdades Metropolitanas Unidas

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparação Entre o Teste de Caminhada de Seis Minutos e o Teste do Degrau de Seis Minutos em Pacientes Com Acidente Vascular Encefálico.

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 20, 2011

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations