Healia Clinical Trials Information Database

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.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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