Actively Recruiting

Age: 6Years - 16Years
All Genders
Healthy Volunteers
ID06661278

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

Led by Royal Brompton & Harefield NHS Foundation Trust · Updated on 2025-05-31

110

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

R

Royal Brompton & Harefield NHS Foundation Trust

Lead Sponsor

G

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying children and adolescents aged 6 to 16 years who have inherited arrhythmias, including Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia, to understand how exercise testing relates to their daily physical activity. The study aims to find out if the maximum heart rate reached during controlled exercise tests matches the maximum heart rate during everyday activities. It also compares different exercise testing methods and assesses actual physical activity versus reported activity using questionnaires and diaries. Participants will undergo a routine clinical exercise tolerance test on a treadmill, following a 15-minute protocol with increasing speed and incline. After this test, they will wear activity and heart rate monitors for two weeks to record heart rhythm, heart rate, step count, and types and intensity of physical activity. They will also keep a digital diary and complete a physical activity questionnaire at the end of the monitoring period. Both children with inherited arrhythmias and healthy controls (unaffected siblings or children undergoing screening) will take part. Throughout the study, researchers will collect data from the exercise tests, wearable monitors, digital diaries, and questionnaires to compare heart rate and physical activity levels. Parents may help younger children with diary and questionnaire completion. The study includes an advisory group of children and parents affected by inherited arrhythmias to assist with study design and sharing results. The total observation involves initial testing followed by two weeks of activity monitoring and questionnaires.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female children aged 6 to 16 years
  • Diagnosed with Long QT Syndrome or Catecholaminergic Polymorphic Ventricular Tachycardia and treated with beta-blocker and/or sodium channel blockade (affected cohort)
  • Able to complete a treadmill exercise tolerance test (affected and healthy cohorts)
  • Siblings of affected children who are gene negative or children undergoing screening (healthy cohort)
Not Eligible

You will not qualify if you...

  • Children younger than 6 years
  • Adults aged 17 years and above
  • Unable to run on an exercise treadmill due to physical limitations
  • Unable to speak or understand English due to no translation service available
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo a clinical exercise tolerance test using an exercise treadmill to assess heart rhythm and exercise response according to the arrhythmia protocol.

1 visit (in-person)

Monitoring

Duration - 2 weeks

Participants wear physical activity and heart rate monitors for two weeks to record heart rate, heart rhythm, activities engaged in, and estimated intensity of activities during free-living physical activity.

Continuous monitoring over 2 weeks with device use

Follow-up Assessment

Duration - 1 day

Participants complete a questionnaire about their physical activity which is compared with data obtained during the monitoring period.

1 visit (in-person or remote) at end of monitoring

Trial Site Locations

Total: 2 locations

1

Great Ormond Street Hospital

London, United Kingdom, WC1N 3JH

Actively Recruiting

2

Royal Brompton Hospital

Sutton, United Kingdom, SW36NP

Actively Recruiting

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Research Team

C

Catherine E Renwick

E

Ethaar El-Emire

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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