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Exercise and Prevention of Syncope: EXPOSE

Primary Purpose

Syncope

Status
Suspended
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Blood volume
VO2max test
Lower body negative pressure
Heart Rate
Blood Pressure
Total Peripheral Resistance
Sponsored by
University of Calgary
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syncope focused on measuring exercise, total peripheral resistance, venoconstriction, blood volume expansion, orthostatic tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • University of Calgary (Health Sciences Center)

Outcomes

Primary Outcome Measures

Orthostatic tolerance - this will be measured at baseline and post intervention

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
March 12, 2007
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT00203593
Brief Title
Exercise and Prevention of Syncope: EXPOSE
Official Title
EXercise for the Prevention of Syncope Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Suspended
Why Stopped
No Resources - No Personnel
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary

4. Oversight

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
Keywords
exercise, total peripheral resistance, venoconstriction, blood volume expansion, orthostatic tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Type
Device
Intervention Name(s)
Blood volume
Intervention Type
Procedure
Intervention Name(s)
VO2max test
Intervention Type
Procedure
Intervention Name(s)
Lower body negative pressure
Intervention Type
Behavioral
Intervention Name(s)
Heart Rate
Intervention Type
Procedure
Intervention Name(s)
Blood Pressure
Intervention Type
Behavioral
Intervention Name(s)
Total Peripheral Resistance
Primary Outcome Measure Information:
Title
Orthostatic tolerance - this will be measured at baseline and post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Sheldon, MD PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary (Health Sciences Center)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

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Exercise and Prevention of Syncope: EXPOSE

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