SyncopePhase 1NCT00203593
Exercise and Prevention of Syncope: EXPOSE
A Phase 1 study testing Exercise, Blood volume and VO2max test in people with Syncope, run by University of Calgary at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Exercise, Blood volume and VO2max test
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary (Health Sciences Center)
Calgary, Alberta, T2N 4N1
About this study
Official title: 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).
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.
- Conditions
- Syncope
- Being tested
- Exercise, Blood volume, VO2max test, Lower body negative pressure, Heart Rate
- Keywords
- exercise, total peripheral resistance, venoconstriction, blood volume expansion, orthostatic tolerance
- Medical subject headings
- Syncope, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Blood volumeDevice
VO2max testProcedure or surgery
Lower body negative pressureProcedure or surgery
Heart RateBehavioural
Blood PressureProcedure or surgery
Total Peripheral ResistanceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic tolerance - this will be measured at baseline and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2006
- Study completionJun 2007
Why it stopped: No Resources - No Personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Robert S Sheldon, MD PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203593
- Sponsor's protocol ID
- 18413
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 14 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXercise for the Prevention of Syncope Evaluation
- ClinicalTrials.gov ID
- NCT00203593
- Acronym / sponsor ID
- 18413
- Conditions
- Syncope
- Keywords
- exercise, total peripheral resistance, venoconstriction, blood volume expansion, orthostatic tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: No Resources - No Personnel
- Enrolment
- 20 participants
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Jun 2007
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Behavioural | – |
| Blood volume | Device | – |
| VO2max test | Procedure or surgery | – |
| Lower body negative pressure | Procedure or surgery | – |
| Heart Rate | Behavioural | – |
| Blood Pressure | Procedure or surgery | – |
| Total Peripheral Resistance | Behavioural | – |
Primary outcome
Orthostatic tolerance - this will be measured at baseline and post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Sheldon, MD PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise, Blood volume and VO2max test in people with Syncope, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic tolerance - this will be measured at baseline and post intervention. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2007; AzTrials last refreshed its copy on 31 Oct 2026.