Exercise and Prevention of Syncope: EXPOSE

March 12, 2007 updated by: University of Calgary

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).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary (Health Sciences Center)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Robert S Sheldon, MD PhD, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2007

Last Update Submitted That Met QC Criteria

March 12, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Syncope

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe