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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-16
SponsorRoyal Brompton & Harefield NHS Foundation Trust

About this trial

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?

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Exercise tolerance test

    Diagnostic 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 monitoring

    Other intervention

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Affected2 interventions
Group B: Unaffected2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
End of two-week physical activity monitoring (week two of study assessments)

Secondary outcomes

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)

Time frame
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.

Time frame
Immediately after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal Brompton & Harefield NHS Foundation Trust

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborator

Guy's and St Thomas' NHS Foundation Trust

Collaborator