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Exercise and Prevention of Syncope: EXPOSE

This study has suspended participant recruitment.
(No Resources - No Personnel)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00203593
First Posted: September 20, 2005
Last Update Posted: March 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Calgary
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: EXercise for the Prevention of Syncope Evaluation

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Orthostatic tolerance - this will be measured at baseline and post intervention

Estimated Enrollment: 20
Study Start Date: March 2006
Estimated Study Completion Date: June 2007
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203593


Locations
Canada, Alberta
University of Calgary (Health Sciences Center)
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Robert S Sheldon, MD PhD University of Calgary
  More Information

ClinicalTrials.gov Identifier: NCT00203593     History of Changes
Other Study ID Numbers: 18413
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: March 14, 2007
Last Verified: March 2007

Keywords provided by University of Calgary:
exercise
total peripheral resistance
venoconstriction
blood volume expansion
orthostatic tolerance

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms