← Back to Search

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

Must not have

Diagnosis of recurrent fainting accompanied by hypoglycemia

Participants taking cardiovascular acting medications or medications for orthostatic syncope (e.g. fludrocortisone, slow-release sodium chloride, β-blockers, midodrine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up final minute of maneuver performance, response to maneuver release.

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.

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.

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 below

Select...

I have fainted or almost fainted at least twice in the past year.

Select...

I am a child aged 6-18 and speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had fainting spells due to low blood sugar.

Select...

I am on medication for heart issues or fainting spells.

Select...

I have heart disease and experience frequent fainting.

Select...

I have a disability that affects my ability to complete certain tests.

Select...

I have been diagnosed with fainting spells due to a heart rhythm problem.

Select...

I have not been fully vaccinated against COVID-19 as per Health Canada.

Select...

I have had fainting spells that resulted in head injuries.

Select...

I have had recent fainting spells and either a new seizure disorder or my epilepsy has come back.

Select...

I have had fainting spells and also suffer from heart disease, high blood pressure, diabetes, or kidney problems.

Select...

I am of childbearing age and am not pregnant nor suspect I might be.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and final minute of maneuver performance for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relationship between postural movement and stroke volume

Secondary study objectives

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.

0 / 12Eligibility criteria met