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Long QT SyndromeACTIVELYNCT06661278

Evaluation of Exercise Testing and Physical Activity in Children and Adolescents Living With Inherited Arrhythmias

An observational study of Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia Type 1, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to evaluate exercise testing and daily physical activity in children and adolescents who are diagnosed with an inherited arrhythmia. The main question it aims to answer is: Does maximum heart rate during controlled exercise tolerance testing accurately reflect maximum heart rate… Read more about this study

Who is it for?
Ages 6 to 16 yearsHealthy volunteers can take part
What is being tested?
Exercise tolerance test and Physical activity & heart rate monitoring
How many people
55 participants
Where
2 sitesUnited Kingdom
Study dates
18 Mar 2025to 31 May 2026
Phase
Observational
Are there results?
None posted in the registry

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 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Affected cohort: 60 children aged 6-16 years, diagnosed with inherited arrhythmias (IAS) Unaffected cohort: 50 healthy children aged 6-16 years (siblings of affected children and those undergoing screening for inherited arrhythmias)

Who may be able to join

  • Affected cohort
  • Male and female children
  • Aged 6-16 years
  • Diagnosed with long QT syndrome or catecholaminergic polymorphic ventricular tachycardia
  • Treated with beta-blocker and/or sodium channel blockade
  • Able to complete a treadmill ETT
Show all 12Show fewer
  • Healthy cohort
  • Male and female children
  • Aged 6-16 years
  • Siblings of affected children (gene negative)
  • Undergoing IAS screening
  • Able to complete a treadmill ETT

Who cannot join

  • Children aged less than 6 years
  • Adults, 17 years of age and above
  • Unable to run on an exercise treadmill due to physical limitations.
  • Individuals unable to speak or understand English, due to no translation service available.
  • Pregnancy

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Great Ormond Street Hospital

    London, WC1N 3JH

  • Royal Brompton Hospital

    Sutton, SW36NP

Other trials in United Kingdom

About this study

Official title: Evaluation of Free-living Physical Activity and the Assessment Tools Used to Support Pharmacological Therapy Titration and Exercise Prescription in Children and Adolescents Diagnosed With Inherited Arrhythmias

The goal of this observational study is to evaluate exercise testing and daily physical activity in children and adolescents who are diagnosed with an inherited arrhythmia.

The main question it aims to answer is: Does maximum heart rate during controlled exercise tolerance testing accurately reflect maximum heart rate and peak exercise levels during free living daily physical activity in children and adolescents diagnosed with an inherited arrhythmia?

Read more

Participants will:

  • Complete routine exercise tolerance testing
  • Record daily physical activity and exercise over two weeks, while wearing an activity and heart rate monitor and digit diary.
  • Complete a physical activity questionnaire at the end of two weeks.
Read the detailed description

Exercise tolerance testing (ETT) using an exercise treadmill is a tool used to assess children's physical response to stress, which is thought to accurately reflect normal physiology during normal daily activities and can be used to:

  • Evaluate heart rhythm and symptoms occurring during exercise.
  • Evaluate children with a family history of sudden death and inherited heart conditions.
  • Assess the response of medications prescribed to control heart rhythm.

The maximum heart rate achieved during ETT is used to estimate the effect of daily medications and to guide exercise prescription.

Originally designed to assess adult heart disease patients, ETTs were not intended for use in children. To accommodate the needs of children, shorter ETT protocols have been developed which increase the speed and/or incline of the treadmill quickly.

Despite this, many children rarely complete the full ETT protocol as they grow tired or develop other symptoms, which leads to them stopping exercise early, resulting in variable lengths of testing.

Children naturally increase exercise effort during day-to-day free-living physical activity (PA). Free-living PA is therefore thought to show a more accurate representation of the maximum heart rate (HR) children can achieve. Presently there is no strong evidence base to determine what children with an Inherited Arrhythmia (IA) (a genetically inherited heart condition which causes abnormalities in the heart rhythm) are doing in terms of daily free-living PA and exercise. The current recommendations used to prescribe exercise for this patient group are based on expert opinion and are not child specific. The study I propose supports the development of a greater evidence base to guide future exercise prescription and better tailored medications.

The study aims to:

  • To compare the maximum HR achieved during controlled ETT with the maximum HR achieved during daily free-living PA and exercise, to see if these are different.
  • To assess three different exercise testing protocols for children, and identify if one is better than the others at estimating maximum heart rate compared with free-living PA.
  • To investigate the actual versus reported PA children engage in using a questionnaire and digital PA diary.

To achieve these aims, the study will recruit children (aged 6-16 years) diagnosed with an IA and who are able to run on an exercise treadmill, plus a healthy control group (unaffected siblings, or children undergoing screening).

A clinical ETT will be performed as part of routine care. Each participant will be given a wearable PA monitoring device to monitor free-living PA over two-weeks. The device will record parameters such as electrocardiogram, HR, and step count. PA will also be recorded digitally to capture type and length of activity they engage in, and estimated intensity.

At the end of the two-weeks, participants will complete a questionnaire about their PA which will be compared with the data obtained during the monitoring period. Parents will be invited to support younger children with questionnaire and digital recording completion.

A study lay advisory group will be established including children and their parents affected by an IA. They will advise on study design and development of all patient-facing information throughout the study.

The results of the study will be discussed with lay advisory groups who will advise on the best ways to share results with the wider public but will include publication in high quality Open Access journals and dissemination at relevant national and international conferences. Invitations will also be provided to the voluntary support groups involved in the early planning phases to publish the results on their websites

Being tested
Exercise tolerance test, Physical activity & heart rate monitoring
Keywords
Children, Adolescents, Exercise, Physical activity, Exercise tolerance testing
Medical subject headings
Long QT Syndrome, Polymorphic Catecholaminergic Ventricular Tachycardia, Motor Activity

What participants receive

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

  • Exercise tolerance testDiagnostic test

    Clinical routine exercise tolerance test using an exercise treadmill, according to the arrhythmia protocol (15 minute protocol utilising increasing speed and incline with a 6 minute recovery)

  • Physical activity & heart rate monitoringOther

    Physical activity monitoring over two weeks using Actiheart and Pro-Diary monitors to record heart rate, heart rhythm, activities engaged in and estimated intensity of activities.

Study groups in NCT06661278
Study groupRoleWhat they receive
AffectedChildren diagnosed with Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia
Receives: Diagnostic Test: Exercise tolerance test; Other: Physical activity & heart rate monitoring
UnaffectedHealthy children (siblings of affected or those undergoing screening)
Receives: Diagnostic Test: Exercise tolerance test; Other: Physical activity & heart rate monitoring

What is being measured

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

  1. Correlation of maximum heart rate during clinical exercise tolerance test and daily physical activity

    Assess the correlation between maximum heart rate (HRmax) obtained during controlled exercise tolerance test (ETT) and wearable heart rate devices during daily free-living (FL) physical activity (PA) and exercise.

    Measured: Baseline assessment (week one of study assessments)

  2. Physical activity questionnaire

    Investigate actual versus reported PA children engage in using a questionnaire to record accuracy of child/parent recall of the type and intensity of PA.

    Measured: End of two-week physical activity monitoring (week two of study assessments)

Secondary outcomes (2)
  1. Heart rate assessment during exercise tolerance testing

    Assess differences in HRmax relative to age of children completing three ETT protocols i. Bruce/modified Bruce with accelerated sprint - Evelina London Children's Hospital (ELCH) ii. Arrhythmia high intensity (HIT) - Royal Brompton Hospital (RBH) iii. Arrhythmia - Great Ormond Street Hospital (GOSH)

    Measured: Baseline assessment (week one of study assessment)

  2. Comparison of exercise tolerance testing protocols

    To compare protocols between the centres to determine if one protocol correlates more closely with HRmax (protocol completion or no further rise in HR despite increasing workload) achieved during FL PA.

    Measured: Immediately after the intervention

Timeline

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

  1. First posted28 Oct 2024
  2. Study start18 Mar 2025
  3. Primary completion31 May 2026
  4. Study completion31 May 2026

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06661278
Sponsor's protocol ID
341211
Acronym
ACTIVELY
Status last verified
Aug 2026
First submitted
29 Aug 2024
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To be completed

Publications

  • Chockalingam P, Wilde AA. Inherited arrhythmia syndromes leading to sudden cardiac death in the young: a global update and an Indian perspective. Indian Heart J. 2014 Jan-Feb;66 Suppl 1(Suppl 1):S49-57. doi: 10.1016/j.ihj.2013.11.008. Epub 2013 Dec 17.

    PubMed 24568830
  • Zarain-Herzberg A, Estrada-Aviles R, Fragoso-Medina J. Regulation of sarco(endo)plasmic reticulum Ca2+-ATPase and calsequestrin gene expression in the heart. Can J Physiol Pharmacol. 2012 Aug;90(8):1017-28. doi: 10.1139/y2012-057. Epub 2012 Jul 11.

    PubMed 22784385
  • Gibbons RJ, Balady GJ, Beasley JW, Bricker JT, Duvernoy WF, Froelicher VF, Mark DB, Marwick TH, McCallister BD, Thompson PD, Winters WL Jr, Yanowitz FG, Ritchie JL, Cheitlin MD, Eagle KA, Gardner TJ, Garson A Jr, Lewis RP, O'Rourke RA, Ryan TJ. ACC/AHA guidelines for exercise testing: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). Circulation. 1997 Jul 1;96(1):345-54. doi: 10.1161/01.cir.96.1.345. No abstract available.

    PubMed 9236456
  • Mellor GJ, Behr ER. Cardiac channelopathies: diagnosis and contemporary management. Heart. 2021 Jun 11;107(13):1092-1099. doi: 10.1136/heartjnl-2019-316026. No abstract available.

    PubMed 33589428
  • Cheung CC, Laksman ZW, Mellor G, Sanatani S, Krahn AD. Exercise and Inherited Arrhythmias. Can J Cardiol. 2016 Apr;32(4):452-8. doi: 10.1016/j.cjca.2016.01.007. Epub 2016 Jan 14.

    PubMed 26927864
  • Bruce RA, Blackmon JR, Jones JW, Strait G. Exercising testing in adult normal subjects and cardiac patients. 1963. Ann Noninvasive Electrocardiol. 2004 Jul;9(3):291-303. doi: 10.1111/j.1542-474X.2004.93003.x. No abstract available.

    PubMed 15245347
  • Sagray E, Allison TG, Wackel PL. Is a high-intensity exercise test better than a graded exercise test in eliciting exercise-related arrhythmias? HeartRhythm Case Rep. 2021 May 15;7(8):549-552. doi: 10.1016/j.hrcr.2021.05.001. eCollection 2021 Aug. No abstract available.

    PubMed 34434706
  • Duff DK, De Souza AM, Human DG, Potts JE, Harris KC. A novel treadmill protocol for exercise testing in children: the British Columbia Children's Hospital protocol. BMJ Open Sport Exerc Med. 2017 Apr 22;3(1):e000197. doi: 10.1136/bmjsem-2016-000197. eCollection 2017.

    PubMed 28761700
  • van der Cammen-van Zijp MH, Ijsselstijn H, Takken T, Willemsen SP, Tibboel D, Stam HJ, van den Berg-Emons RJ. Exercise testing of pre-school children using the Bruce treadmill protocol: new reference values. Eur J Appl Physiol. 2010 Jan;108(2):393-9. doi: 10.1007/s00421-009-1236-x. Epub 2009 Oct 11.

    PubMed 19821120
  • CAVAGNA GA, SAIBENE FP, MARGARIA R. MECHANICAL WORK IN RUNNING. J Appl Physiol. 1964 Mar;19:249-56. doi: 10.1152/jappl.1964.19.2.249. No abstract available.

    PubMed 14155290
  • Schepens B, Willems PA, Cavagna GA. The mechanics of running in children. J Physiol. 1998 Jun 15;509 ( Pt 3)(Pt 3):927-40. doi: 10.1111/j.1469-7793.1998.927bm.x.

    PubMed 9596810
  • Van Hooren B, Fuller JT, Buckley JD, Miller JR, Sewell K, Rao G, Barton C, Bishop C, Willy RW. Is Motorized Treadmill Running Biomechanically Comparable to Overground Running? A Systematic Review and Meta-Analysis of Cross-Over Studies. Sports Med. 2020 Apr;50(4):785-813. doi: 10.1007/s40279-019-01237-z.

    PubMed 31802395
  • Schoffl I, Ehrlich B, Stanger S, Rottermann K, Dittrich S, Schoffl V. Exercise Field Testing in Children: A New Approach for Age-Appropriate Evaluation of Cardiopulmonary Function. Pediatr Cardiol. 2020 Aug;41(6):1099-1106. doi: 10.1007/s00246-020-02359-2. Epub 2020 May 9.

    PubMed 32388667
  • Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.

    PubMed 32860412
  • Priori SG, Blomstrom-Lundqvist C. 2015 European Society of Cardiology Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death summarized by co-chairs. Eur Heart J. 2015 Nov 1;36(41):2757-9. doi: 10.1093/eurheartj/ehv445.

    PubMed 26745817

Questions about this trial

What is this clinical trial studying?

An observational study of Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia Type 1, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.

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 12 inclusion and 5 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of maximum heart rate during clinical exercise tolerance test and daily physical activity (time frame: Baseline assessment (week one of study assessments)). The study lists 2 primary outcomes in all. 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 NCT06661278, which also lists 19 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 1 Sep 2026.

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