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

May 30, 2025 updated by: Renwick Catherine, Royal Brompton & Harefield NHS Foundation Trust

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?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital
        • Contact:
        • Principal Investigator:
          • Juan Pablo Kaski
      • London Borough of Sutton, United Kingdom, SW36NP
        • Recruiting
        • Royal Brompton Hospital
        • Contact:
        • Principal Investigator:
          • Catherine Renwick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

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

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Affected
Children diagnosed with Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia
Diagnostic test: Exercise tolerance 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)
Other: Physical activity & heart rate monitoring
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.
Unaffected
Healthy children (siblings of affected or those undergoing screening)
Diagnostic test: Exercise tolerance 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)
Other: Physical activity & heart rate monitoring
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of maximum heart rate during clinical exercise tolerance test and daily physical activity
Time Frame: Baseline assessment (week one of study assessments)
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.
Baseline assessment (week one of study assessments)
Physical activity questionnaire
Time Frame: End of two-week physical activity monitoring (week two of study assessments)
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.
End of two-week physical activity monitoring (week two of study assessments)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate assessment during exercise tolerance testing
Time Frame: Baseline assessment (week one of study assessment)
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)
Baseline assessment (week one of study assessment)
Comparison of exercise tolerance testing protocols
Time Frame: Immediately after the intervention
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.
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Guy's and St Thomas' NHS Foundation Trust
Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

  • Principal Investigator: Catherine E Renwick, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 29, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 341211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To be completed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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