NCT00203593

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 14, 2007

Status Verified

March 1, 2007

First QC Date

September 13, 2005

Last Update Submit

March 12, 2007

Conditions

Syncope

Keywords

exercisetotal peripheral resistancevenoconstrictionblood volume expansionorthostatic tolerance

Outcome Measures

Primary Outcomes (1)

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

Interventions

ExerciseBEHAVIORAL
Blood volumeDEVICE
VO2max testPROCEDURE
Lower body negative pressurePROCEDURE
Heart RateBEHAVIORAL
Blood PressurePROCEDURE
Total Peripheral ResistanceBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary (Health Sciences Center)

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

SyncopeMotor Activity

Interventions

ExerciseBlood Volume DeterminationLower Body Negative PressureHeart RateBlood PressureVascular Resistance

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisDecompressionTherapeuticsVital SignsPhysical ExaminationHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Robert S Sheldon, MD PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

March 1, 2006

Study Completion

June 1, 2007

Last Updated

March 14, 2007

Record last verified: 2007-03

Locations

CA(1)