Exercise and Prevention of Syncope: EXPOSE

NCT ID: NCT00203593

Last Updated: 2007-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Syncope

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Exercise

Intervention Type BEHAVIORAL

Blood volume

Intervention Type DEVICE

VO2max test

Intervention Type PROCEDURE

Lower body negative pressure

Intervention Type PROCEDURE

Heart Rate

Intervention Type BEHAVIORAL

Blood Pressure

Intervention Type PROCEDURE

Total Peripheral Resistance

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Principal Investigators

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Robert S Sheldon, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary (Health Sciences Center)

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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18413

Identifier Type: -

Identifier Source: org_study_id

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