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| Sponsored by: |
University of Calgary |
|---|---|
| Information provided by: | University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00203593 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Syncope |
Behavioral: Exercise Device: Blood volume Procedure: VO2max test Procedure: Lower body negative pressure Behavioral: Heart Rate Procedure: Blood Pressure Behavioral: Total Peripheral Resistance |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | EXercise for the Prevention of Syncope Evaluation |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | June 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
-
Contacts and Locations| Canada, Alberta | |
| University of Calgary (Health Sciences Center) | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Principal Investigator: | Robert S Sheldon, MD PhD | University of Calgary |
More Information
| Study ID Numbers: | 18413 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00203593 |
| Health Authority: | Canada: Health Canada |
|
exercise total peripheral resistance venoconstriction blood volume expansion orthostatic tolerance |
|
Signs and Symptoms Unconsciousness Consciousness Disorders |
Neurologic Manifestations Neurobehavioral Manifestations Syncope |
|
Nervous System Diseases |
