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Main
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Note: This record shows only 22 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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00203593 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Exercise and Prevention of Syncope: EXPOSE
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Scientific title:
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EXercise for the Prevention of Syncope Evaluation |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT00203593 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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Robert S Sheldon, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Calgary |
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Key inclusion & exclusion criteria
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Inclusion Criteria: a diagnosis of vasovagal syncope as the cause of loss of
consciousness, >1 lifetime syncope spell preceding enrolment, >-3 points on the S3 score
for structurally normal hearts, >18 yrs of age with informed consent -
Exclusion Criteria: subjects with a negative Physical Activity Readiness Questionnaire
(PARQ), those who are unable to provide informed consent, those with a VO2max
>55ml/kg/min, those who exercise more than 30 minutes per day, 3 times per week, other
causes of syncope, individuals with valvular, coronary, myocardial, or conductive
abnormality, significant arrhythmia, hypertrophic cardiomyopathy, permanent pacemaker,
seizure disorder, heart failure, major chronic cardiovascular disease, or renal
dysfunction.
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Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Syncope
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Intervention(s)
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Behavioral: Heart Rate
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Device: Blood volume
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Procedure: VO2max test
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Procedure: Blood Pressure
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Behavioral: Exercise
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Behavioral: Total Peripheral Resistance
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Procedure: Lower body negative pressure
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Primary Outcome(s)
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Orthostatic tolerance - this will be measured at baseline and post intervention
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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