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Postural Sway and Counterpressure Maneuvers for Pediatric Syncope

ConditionsSyncope, VasovagalPostural Orthostatic Tachycardia SyndromeOrthostatic Intolerance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorSimon Fraser University

About this trial

The investigators are interested in whether discrete counterpressure maneuvers, or muscle movements in the lower body, will boost blood pressure and cardiovascular control in children who faint. We will record cardiovascular responses to maneuvers of exaggerated sway, leg crossing, crouching, and gluteal muscle tensing in children who faint (N=20), as well as their height, weight, muscularity, and pubertal (Tanner) stage. Autonomic cardiovascular control will be measured using a Valsalva manoeuvre (expiration against a closed airway for 20 seconds) and a supine-stand test. The primary outcomes are noninvasive measures of cardiovascular responses to the maneuvers (blood pressure, cerebral blood flow, and stroke volume (volume of blood pumped per heartbeat). Comparisons will be made across levels of sex, diagnosis, Tanner stage, muscularity, height, and degree of autonomic control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Suspected or confirmed cardiac arrhythmia (e.g., Wolff-Parkinson-White, Long QT)

Traumatic head injury

New presentation of a seizure disorder OR epilepsy recurrence

Overdose or intoxication

Trial design

Design model

Parallel

Treatments tested in this trial

  • Counterpressure Maneuvers

    Behavioral

    Movements that can aid in delaying or preventing syncope by recruiting skeletal muscle pumping (via compression of major veins by contracting muscle to eject blood through cardiovascular circuit) and increased sympathetic drive (via sustaining an isometric muscle contraction). In this trial, we will be evaluating two clinically recommended isometric maneuvers (crouching, and leg crossing with muscle tensing) and two novel dynamic maneuvers that comprise discrete movement that the investigators have identified in prior work (exaggerated anterior-posterior postural sway, rhythmic gluteal clenching).

  • Baseline Stand

    Behavioral

    Participants will stand quietly for 5-minutes on a force platform to allow the investigators to assess their typical response to orthostasis.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Counterpressure ManeuversExperimental treatment 2 interventions
Group B: Baseline StandSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Relationship between postural movement and stroke volume

We will correlate these two parameters using both time and frequency domain approaches. We will compare this between the five movement conditions using a one-way repeated measures ANOVA.

Time frame
Final minute of maneuver performance

Secondary outcomes

1

Relationship between anthropometry and response magnitude

We will evaluate the relationship between responses to the CPM and factors of muscle mass and height. We will evaluate this using correlation, regression, and AIC analyses.

Time frame
Final minute of maneuver performance
2

Relationship between tanner stage and response magnitude

We will compare responses across tanner stages using a 2-way repeated measures ANOVA. We will also consider sex differences in cardiovascular responses to the maneuver, again using a 2-way repeated measures ANOVA

Time frame
Final minute of maneuver performance
3

Relationship between autonomic control and response magnitude

We will use responses to the Valsalva maneuver and sit-stand test to determine participant autonomic control. Relationships between autonomic control will be evaluated using correlation/regression/AIC analyses. Comparisons between syncopal diagnoses will be made using a 2-way Repeated Measures ANOVA

Time frame
Final minute of maneuver performance, response to maneuver release.

Other outcomes

Sponsors and contacts

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Simon Fraser University

Lead sponsor

Provincial Health Services Authority British Columbia

Collaborator

University of British Columbia

Collaborator

Natural Sciences and Engineering Research Council, Canada

Collaborator

Source ClinicalTrials.gov
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