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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-5tmjnd |
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Date of registration:
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31/01/2012 |
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Primary sponsor: |
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Public title:
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Effect of physical conditioning in patients with spinal cord injury to increase physical resistance.
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Scientific title:
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Effectiveness of aerobic physical training applied to patients with spinal cord injury to increase oxygen consumption. |
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Date of first enrolment:
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10/01/2010 |
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Target sample size:
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21 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-5tmjnd/ |
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Study type:
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Study design:
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Clinical Trial, randomized, controlled, single-blind, two arms.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Edson
Lavado |
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Address:
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Av Robert Kock, 60
86038350
Londrina
Brazil |
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Telephone:
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55 43 33712288 |
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Email:
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lavado@uel.br |
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Affiliation:
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Universidade Estadual de Londrina |
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Name:
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Edson
Lavado |
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Address:
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Av Robert Kock, 60
86038350
Londrina
Brazil |
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Telephone:
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55 43 33712288 |
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Email:
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lavado@uel.br |
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Affiliation:
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Universidade Estadual de Londrina |
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Key inclusion & exclusion criteria
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Inclusion criteria: Individuals with SCI between segments C5 and L2 according to the classification of the American Spinal Injury Association
Exclusion criteria: Individuals who do regular physical activity, community ambulators and individuals who were unable to pedal the cycle ergometer with their arms.
Age minimum:
18Y
Age maximum:
60Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injury C10.228.854 C10.228.854.770
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Intervention(s)
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42 subjects with spinal cord injury between C5 and L2 segments regions were randomized into two groups. In the intervention group, subjects were submitted to a risk evaluation and effort test before the start of the study and again after 16 weeks. It consisted of aerobic physical conditioning with moderate intensity for the Intervention group while the Control group was oriented to maintain their daily life activities.
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Primary Outcome(s)
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Increase oxygen consumption of intervention group comparing before the start of the study and again after 16 weeks. The stress test was used to measure oxygen consumption and was performed with an upper limb ergometer Cybex ®. The ergometry protocol used was of progressive loads with increments of 150 kilogrameters every 3 minutes of cycling followed by 1 minute of rest after each stage. In each rest phase heart rate and blood pressure were measured. For security reasons, it was chosen to work with the heart rate at 85% or 90% of maximum, accompanied by the perceived exertion scale.
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Secondary Outcome(s)
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Maintenance of oxygen consumption in the control group after 16 weeks.
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Source(s) of Monetary Support
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Universidade Estadual de Londrina - Londrina, PR, Brazil
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