Postural Sway and Counterpressure Maneuvers for Pediatric Syncope

NCT05633693 | Recruiting

• 1 other identifier: H22-02694
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Syncope, Vasovagal; Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance

Outcome Measures

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.

  Final minute of maneuver performance

Secondary Outcomes (3)

• Relationship between anthropometry and response magnitude

  Final minute of maneuver performance

• Relationship between tanner stage and response magnitude

  Final minute of maneuver performance

• Relationship between autonomic control and response magnitude

  Final minute of maneuver performance, response to maneuver release.

Study Arms (2)

Counterpressure Maneuvers

EXPERIMENTAL

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.

Behavioral: Counterpressure Maneuvers; Behavioral: Baseline Stand

Baseline Stand

SHAM COMPARATOR

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.

Behavioral: Counterpressure Maneuvers; Behavioral: Baseline Stand

Interventions

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).

Also known as: Physical counter maneuvers, counter maneuvers,

Baseline Stand; Counterpressure Maneuvers

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.

Also known as: Quiet standing

Baseline Stand; Counterpressure Maneuvers

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• We are looking for English speaking pediatric patients aged 6-18 years with a diagnosis of recurrent fainting (at least two episodes of fainting with loss of consciousness or near loss of consciousness in the last year) of a vasovagal origin or associated with the postural orthostatic tachycardia syndrome (POTS) (as determined by a paediatric cardiologist) to take part in this study.

You may not qualify if:

• Those with a diagnosis of recurrent fainting accompanied by any of the following will not be eligible to take part:
• Known history of:
• 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
• Structural heart disease
• Cardiovascular disease including hypertension, diabetes, or renal disease
• Hypoglycemia
• Physical and/or psychological disability that impact their ability to complete the tests
• Female participants of childbearing age will be excluded if they are pregnant, or think they might be. Participants who are taking any cardiovascular acting medications, including treatment for cardiovascular disease, or medications for orthostatic syncope (e.g. fludrocortisone, slow-release sodium chloride, β-blockers, midodrine) will be excluded from the study.
• In order to reduce the likelihood of transmission of COVID-19, participants will only be eligible to participate in the study if they have received full immunisation against COVID-19 according to current Health Canada guidelines. Accordingly, participants will be asked to provide evidence of their vaccination status in order to take part in the study.

Sponsors & Collaborators

• Simon Fraser University: lead
• Provincial Health Services Authority British Columbia: collaborator
• University of British Columbia: collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

Simon Fraser University

Burnaby, British Columbia, V5A1S6, Canada

RECRUITING

Related Publications (8)

• Clarke DA, Medow MS, Taneja I, Ocon AJ, Stewart JM. Initial orthostatic hypotension in the young is attenuated by static handgrip. J Pediatr. 2010 Jun;156(6):1019-1022.e1. doi: 10.1016/j.jpeds.2010.01.035. Epub 2010 Mar 28.

  PMID: 20350727 BACKGROUND

• Williams EL, Khan FM, Claydon VE. Counter pressure maneuvers for syncope prevention: A semi-systematic review and meta-analysis. Front Cardiovasc Med. 2022 Oct 13;9:1016420. doi: 10.3389/fcvm.2022.1016420. eCollection 2022.

  PMID: 36312294 BACKGROUND

• Inamura K, Mano T, Iwase S, Amagishi Y, Inamura S. One-minute wave in body fluid volume change enhanced by postural sway during upright standing. J Appl Physiol (1985). 1996 Jul;81(1):459-69. doi: 10.1152/jappl.1996.81.1.459.

  PMID: 8828698 BACKGROUND

• Claydon VE, Hainsworth R. Increased postural sway in control subjects with poor orthostatic tolerance. J Am Coll Cardiol. 2005 Oct 4;46(7):1309-13. doi: 10.1016/j.jacc.2005.07.011.

  PMID: 16198849 BACKGROUND

• Stewart JM, Medow MS, Montgomery LD, McLeod K. Decreased skeletal muscle pump activity in patients with postural tachycardia syndrome and low peripheral blood flow. Am J Physiol Heart Circ Physiol. 2004 Mar;286(3):H1216-22. doi: 10.1152/ajpheart.00738.2003. Epub 2003 Oct 23.

  PMID: 14576081 BACKGROUND

• Claydon VE, Hainsworth R. Postural sway in patients with syncope and poor orthostatic tolerance. Heart. 2006 Nov;92(11):1688-9. doi: 10.1136/hrt.2005.083907. No abstract available.

  PMID: 17041121 BACKGROUND

• van Dijk N, Quartieri F, Blanc JJ, Garcia-Civera R, Brignole M, Moya A, Wieling W; PC-Trial Investigators. Effectiveness of physical counterpressure maneuvers in preventing vasovagal syncope: the Physical Counterpressure Manoeuvres Trial (PC-Trial). J Am Coll Cardiol. 2006 Oct 17;48(8):1652-7. doi: 10.1016/j.jacc.2006.06.059. Epub 2006 Sep 26.

  PMID: 17045903 BACKGROUND

• Coupal KE, Heeney ND, Hockin BCD, Ronsley R, Armstrong K, Sanatani S, Claydon VE. Pubertal Hormonal Changes and the Autonomic Nervous System: Potential Role in Pediatric Orthostatic Intolerance. Front Neurosci. 2019 Nov 12;13:1197. doi: 10.3389/fnins.2019.01197. eCollection 2019.

  PMID: 31798399 BACKGROUND

MeSH Terms

Conditions

Syncope, Vasovagal; Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Victoria E Claydon, PhD

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin L Williams, BSc

CONTACT

6048976372; erin_williams_2@sfu.ca

Victoria E Claydon, PhD

CONTACT

778-782-8513; victoria_claydon@sfu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: April 17, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)