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SuspendedNCT00203593Updated Mar 14, 2007

Exercise and Prevention of Syncope: EXPOSE

A Phase 1 interventional study of Exercise and Blood volume in Syncope, sponsored by University of Calgary. Suspended at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-03-14.

Sponsored by University of Calgary · Phase 1, Interventional, and Treatment

Why this study was suspended
No Resources - No Personnel
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Syncope

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Keywords

  • exercise
  • total peripheral resistance
  • venoconstriction
  • blood volume expansion
  • orthostatic tolerance
03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's enrollment of 20 is below the median of 79 across 126 interventional studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
20 participants

Interventions

  • BehavioralExercise
  • DeviceBlood volume
  • ProcedureVO2max test
  • ProcedureLower body negative pressure
  • BehavioralHeart Rate
  • ProcedureBlood Pressure
  • BehavioralTotal Peripheral Resistance
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • University of Calgary (Health Sciences Center)
    Calgary, Alberta T2N 4N1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00203593
Lead sponsor
University of Calgary
First posted
Sep 20, 2005
Start date
Mar 2006
Completion
Jun 2007
Last update
Mar 14, 2007

Study contacts

Robert S Sheldon, MD PhD
principal investigator · University of Calgary
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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