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Counterpressure Maneuvers for Fainting
N/A
Recruiting
Led By Victoria E Claydon, PhD
Research Sponsored by Simon Fraser University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have experienced at least two episodes of fainting with loss of consciousness or near loss of consciousness in the last year
English speaking pediatric patients aged 6-18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up final minute of maneuver performance
Awards & highlights
Study Summary
This trial studies how counterpressure maneuvers, like swaying and muscle tensing, affect children's blood pressure and cardiovascular control when they faint. Measures like blood pressure, cerebral blood flow, and stroke volume will be compared across different groups.
Who is the study for?
This trial is for English-speaking children aged 6-18 with recurrent fainting due to vasovagal syncope or POTS, having fainted at least twice in the last year. It excludes those not fully vaccinated against COVID-19, with seizure disorders, cardiovascular diseases, pregnancy, disabilities affecting test completion, on certain medications for syncope or heart issues.Check my eligibility
What is being tested?
The study tests if counterpressure maneuvers like exaggerated sway and muscle tensing can prevent fainting by improving blood pressure and heart function in kids who faint. Researchers will measure how these movements affect blood flow and heartbeat during a stand test and Valsalva maneuver.See study design
What are the potential side effects?
There may be minimal side effects from participating in this trial as it involves physical maneuvers rather than medication. However, there's a small risk of discomfort or dizziness when performing the counterpressure exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have fainted or almost fainted at least twice in the past year.
Select...
I am a child aged 6-18 and speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ final minute of maneuver performance
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~final minute of maneuver performance
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relationship between postural movement and stroke volume
Secondary outcome measures
Relationship between anthropometry and response magnitude
Relationship between autonomic control and response magnitude
Relationship between tanner stage and response magnitude
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Counterpressure ManeuversExperimental Treatment2 Interventions
Counterpressure maneuver (CPM) trials will be performed in front of a neutral wall in silence to ensure that visual or auditory stimuli do not affect movement.
CPM:
Leg crossing and muscle tensing: Legs are crossed while upright and lower body musculature is isometrically contracted (clinical)
Crouching: Participant crouches down resting weight on the balls of their feet, pressing calves against the back surface of the thighs (clinical)
Exaggerated anterior-posterior sway: Participant sways back and forth with feet planted on ground at a pace/amplitude that is comfortable (discrete)
Gluteal clenching: Participant rhythmically tenses and relaxes the gluteal muscles at a pace/duration that is comfortable (discrete)
Participants serve as their own controls and complete both testing arms.
Group II: Baseline StandPlacebo Group2 Interventions
Participants will perform a sit-stand test, followed by 5-minutes of baseline (quiet) standing trial on a force platform while cardiorespiratory responses are recorded.
Sit-stand test: following 5-minutes of supine rest, the participant will be passively moved into the seated position. They will then be asked to actively move into the standing position.
Baseline stand: immediately following the sit-stand test, the baseline trial will begin. Participants will stand quietly on the force platform for 5-minutes. This trial will be performed in front of a neutral wall in silence to ensure that visual or auditory stimuli do not affect their movement.
Participants serve as their own controls and complete both testing arms.
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Who is running the clinical trial?
Simon Fraser UniversityLead Sponsor
52 Previous Clinical Trials
9,568 Total Patients Enrolled
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Natural Sciences and Engineering Research Council, CanadaOTHER
58 Previous Clinical Trials
3,071 Total Patients Enrolled
Provincial Health Services AuthorityOTHER
39 Previous Clinical Trials
31,565 Total Patients Enrolled
1 Trials studying Orthostatic Intolerance
300 Patients Enrolled for Orthostatic Intolerance
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a child aged 6-18 and speak English.I have been diagnosed with fainting spells due to a heart rhythm problem.I have had fainting spells due to low blood sugar.I have heart disease and experience frequent fainting.I have a disability that affects my ability to complete certain tests.I am on medication for heart issues or fainting spells.I have fainted or almost fainted at least twice in the past year.I have not been fully vaccinated against COVID-19 as per Health Canada.I have been diagnosed with recurrent fainting or POTS by a pediatric cardiologist.I have had fainting spells that resulted in head injuries.I have had recent fainting spells and either a new seizure disorder or my epilepsy has come back.I have had fainting spells and also suffer from heart disease, high blood pressure, diabetes, or kidney problems.I am of childbearing age and am not pregnant nor suspect I might be.You have a history of fainting due to taking too much medication or being intoxicated.
Research Study Groups:
This trial has the following groups:- Group 1: Baseline Stand
- Group 2: Counterpressure Maneuvers
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity for volunteers to join this medical research?
"As reported on clinicaltrials.gov, this experiment is currently recruiting participants since its initial posting date of 17th April 2023 and subsequent update the same day."
Answered by AI
Are minors allowed to participate in this scientific investigation?
"The parameters of this trial require that potential participants are within the age range of 6 to 18. Furthermore, it is established that there are 20 studies for those younger than 18 and 121 above 65 years old."
Answered by AI
How many individuals have been added to the trial cohort thus far?
"Affirmative. This clinical trial, which was published on April 17th 2023 and updated the same day, is currently seeking enrolment. Thirty patients need to be recruited from 1 location for this medical study."
Answered by AI
Do I meet the prerequisites necessary to take part in this experiment?
"This investigation is searching for 30 English-speaking children, aged 6 to 18 years old, who presently have postural orthostatic tachycardia syndrome (POTS). In addition to this requirement, potential participants must have experienced two episodes of fainting or near loss of consciousness within the past year due to vasovagal origin."
Answered by AI
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