EXercise for the Prevention of Syncope Evaluation
The purpose of this study is to determine whether eight weeks of exercise performed at an intensity of approximately 65% VO2max will improve symptoms associated with fainting (vasovagal syncope).
Description
Background: Vasovagal syncope affects 20-30% of the population, and for those who faint recurrently it causes a significant reduction in the quality of life. Although significant progress has been made in the past 15 years in our understanding of its diagnosis and prognosis, our therapeutic attempts often end in failure. Many patients who have been diagnosed with vasovagal syncope have a reduced orthostatic tolerance. Improved orthostatic tolerance has been achieved through exercise in a number of studies on healthy individuals. However, its efficacy as a means of treatment for those with vasovagal syncope has not been thoroughly explored.
Comparison: Subjects will be randomized to one of two groups: an exercise group or control. The exercise group will be asked to train at a target of approximately 65% of their maximum exercise capacity (VO2max) for 8 weeks/3 times per week. The control group will be asked to perform a series of neck rotation exercises. Orthostatic tolerance will be examined in both groups pre and post intervention.
Status: Suspended (Phase 1). Started on March 1st, 2006. Ended on June 1st, 2007.
Enrollment: 20 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Single Blind
- Placebo Control
- Parallel Assignment
- Efficacy Study
Conditions:
Interventions:
- Behavioral: Exercise
- Device: Blood volume
- Procedure: VO2max test
- Procedure: Lower body negative pressure
- Behavioral: Heart Rate
- Procedure: Blood Pressure
- Behavioral: Total Peripheral Resistance
Eligibility
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.
-
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: University of Calgary
Authority: Canada: Health Canada
Locations
-
University of Calgary (Health Sciences Center)
Calgary
Alberta
T2N 4N1
Canada
Officials
Robert S Sheldon, MD PhD (Principal Investigator, University of Calgary)
Sponsors
University of Calgary (Lead Sponsor)
References
None.
Links
- Date Verified
- March 1st, 2007
- First Received
- March 12th, 2007
- Last Changed
- March 12th, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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