AzTrials
AzTrials

Syncope, VasovagalNCT05633693

Postural Sway and Counterpressure Maneuvers for Pediatric Syncope

A study testing Counterpressure Maneuvers and Baseline Stand in people with Syncope, Vasovagal and Postural Orthostatic Tachycardia Syndrome, run by Simon Fraser University at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
What is being tested?
Counterpressure Maneuvers and Baseline Stand
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteCanada
Study dates
17 Apr 2023to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Erin L Williams, BSc contact

6048976372

erin_williams_2@sfu.ca

Victoria E Claydon, PhD contact

778-782-8513

victoria_claydon@sfu.ca

Canada1 site, 1 recruiting
  • Simon Fraser University

    Burnaby, British Columbia, V5A1S6

    Victoria Claydon, PhD, 07788588118, victoria_claydon@sfu.ca

    Recruiting

Other trials in Canada

About this study

Official title: Impact of Postural Sway on Cardiovascular Control in Pediatric Patients With Syncope

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.

Read the detailed description

Purpose: The primary purpose of this investigation is to determine whether discrete counterpressure maneuvers (CPM; exaggerated sway, rhythmic gluteal muscle clenching) can demonstrably improve the return of blood to the heart and the blood pressure in paediatric patients with recurrent uncomplicated syncope (fainting), and to assess whether these discrete CPM are more effective than those commonly recommended in the clinic (leg crossing, crouching).

Protocol: Volunteers (n=35) will be asked to attend one testing session. Testing will take approximately 1.5 hours. Tests will usually be conducted in the mornings. On the day of the test volunteers will be asked to have only a light breakfast avoiding caffeine, and should avoid strenuous exercise for at least 12 hours prior to testing. Female participants that have reached menarche will be asked to make a note of the date of their last period (we would prefer to schedule testing on a day when they do not have, or expect, their period because this may influence orthostatic tolerance).

Prior to testing volunteers will be asked a brief narrative medical history including questions regarding their syncopal diagnosis, and as to whether they have any known cardiovascular or neurological disease, are taking any medications, and questions about general cardiovascular risk factors such as smoking, and alcohol consumption. Participants will also be asked to complete a short questionnaire about their fainting spells. All participants will be asked to self-identify their stage in pubertal development ("Tanner" stage) based on drawn images of biologically male and female bodies at each stage. If participants to not identify with these images, have difficulty answering the question, or do not wish to answer for any reason, they do not have to do so (and are not required to provide this reason). Participants will then complete the PEDS-QL (Pediatric Quality of Life Inventory) and PAQ (Physical Activity Questionnaire). Measures of height, weight and muscle mass will be taken using a height chart and impedance-based weighing scale. Anthropometric measurements of body composition (skinfold thickness: bicep, tricep, thigh, medial calf; circumference: mid-upper arm, mid-thigh, mid-calf) will also be performed. A copy of the prompt sheet used by the investigators to facilitate taking the medical history is included with the submission. This form outlines the medical history data collected in general terms and is used to guide a narrative history. Participants will be asked to empty their bladder in the nearby washroom, and to retain a sample of their urine for testing for sodium levels (a marker of salt intake and hydration). One the urine has been tested it will be discarded. No biological samples will be retained. A brief instruction on the different tests of nervous system function ("Valsalva maneuver") and movement patterns (see below) will occur.

Participants will then be asked to lie down on a standard hospital style examination bed. The investigators will then attach the following CSA approved cardiovascular monitoring (all monitors are non-invasive and painless):

  1. A standard 3 lead electrocardiogram (ECG) will be recorded to assess heart rate and rhythm.
  2. Beat-to-beat blood pressure will be determined using the Finometer blood pressure monitoring device. This consists of a small Velcro cuff placed around the middle finger that pulses gently against the digital arteries and records and displays blood pressure with every heartbeat.
  3. End tidal gases will be sampled using a nasal cannula. This is to enable us to evaluate any influence of possible hyperventilation and the associated decreases in carbon dioxide on cerebral blood flow.
  4. Cerebral blood flow will be determined in the middle cerebral artery using Doppler ultrasound. An ultrasound probe will positioned on the skin overlying the temple and held in place with a head band. Participants can move their head freely when wearing the ultrasound probe.
  5. Brachial blood flow will be determined using an ultrasound probe positioned overlaying the brachial artery in the upper arm. The probe will be positioned on the participant's arm using an adjustable holder. It will only be in place during the initial supine period, and the Valsalva maneuver.

Once the monitors are in place, participants will be asked to perform two Valsalva manoeuvres, which is a test of parasympathetic and sympathetic control of the circulatory system and cardiac baroreflex function. During this test, participants will blow out against a closed tube to produce a Valsalva strain (performed as though they were blowing up a balloon that would not inflate, generating a pressure of 40mmHg) and sustain this for 20 seconds. The tube will be connected to a manometer (provides a pressure reading) so the participant can regulate their expiratory pressure. The participant will perform one Valsalva maneuver while lying supine, and a second while sitting upright. Responses will be monitored continuously using the equipment mentioned above.

Next, the participants will complete a 5-minute supine rest period, after which they will be asked to rise from the supine to the standing position and stand on the force platform while we record their cardiovascular and cerebrovascular responses for 5 minutes. Volunteers will stand without shoes, and will be asked not to move their feet for the duration of each standing trial. Following this, volunteers will perform four more bouts of a 5-minute supine period, followed by a 5-minute standing period on the force platform. During each of these trials, they will perform one of the following movements:

  1. Exaggerated anterior-posterior sway: rocking the body in a fore-aft motion, as far as comfortably possible without raising the heels or toes off the force platform
  2. Gluteal clenching: rhythmic tensing of the thighs and buttocks
  3. Crouching: lowering body to the floor in a crouched position
  4. Leg crossing with muscle tensing: standing with legs crossed for the first 4 minutes of the trial, clenching legs in the crossed position for the final minute.

These standing trials will be completed in a randomized order. Following their completion, testing will be concluded. The monitoring equipment will be removed and any residue from the ultrasound gel will be wiped away by the participant.

Testing will stop if the volunteer experiences symptoms of presyncope, decreased blood pressure (<80mmHg systolic pressure for greater than 5 consecutive heart beats), slowing of the heart rate (new onset bradycardia below 50bpm), or at the participant's request. In such an instance the participant will be asked to lie flat until any symptoms or signs of presyncope resolve. If participants meet criteria to stop testing during one of the standing phases, but haven't yet finished all standing phases, they can decide if they want to try the next standing phase, or stop testing all together.

Being tested
Counterpressure Maneuvers, Baseline Stand
Medical subject headings
Syncope, Vasovagal, Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Counterpressure ManeuversBehavioural

    Also called Physical counter maneuvers, counter maneuvers,

    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 StandBehavioural

    Also called Quiet standing

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

Study groups in NCT05633693
Study groupRoleWhat they receive
Counterpressure ManeuversExperimentalCounterpressure 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.
Receives: Behavioral: Counterpressure Maneuvers; Behavioral: Baseline Stand
Baseline StandSham comparatorParticipants 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.
Receives: Behavioral: Counterpressure Maneuvers; Behavioral: Baseline Stand

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Final minute of maneuver performance

Secondary outcomes (3)
  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.

    Measured: 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

    Measured: 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

    Measured: Final minute of maneuver performance, response to maneuver release.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2022
  2. Study start17 Apr 2023
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05633693
Sponsor's protocol ID
H22-02694
Status last verified
Apr 2026
First submitted
21 Nov 2022
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20350727
  • 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.

    PubMed 36312294
  • 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.

    PubMed 8828698
  • 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.

    PubMed 16198849
  • 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.

    PubMed 14576081
  • 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.

    PubMed 17041121
  • 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.

    PubMed 17045903
  • 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.

    PubMed 31798399

Questions about this trial

What is this clinical trial studying?

A study testing Counterpressure Maneuvers and Baseline Stand in people with Syncope, Vasovagal and Postural Orthostatic Tachycardia Syndrome, run by Simon Fraser University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erin L Williams, BSc (6048976372, erin_williams_2@sfu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship between postural movement and stroke volume (time frame: Final minute of maneuver performance). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05633693, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in