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

NCT06661278 | Recruiting

• 1 other identifier: 341211
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Long QT Syndrome; Catecholaminergic Polymorphic Ventricular Tachycardia Type 1; Catecholaminergic Polymorphic Ventricular Tachycardia Type 2

Keywords

Children; Adolescents; Exercise; Physical activity; Exercise tolerance testing

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline assessment (week one of study assessments)

• 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.

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

Secondary Outcomes (2)

• Heart rate assessment during exercise tolerance testing

  Baseline assessment (week one of study assessment)

• Comparison of exercise tolerance testing protocols

  Immediately after the intervention

Study Arms (2)

Affected

Children diagnosed with Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia

Diagnostic Test: Exercise tolerance test; Other: Physical activity & heart rate monitoring

Unaffected

Healthy children (siblings of affected or those undergoing screening)

Diagnostic Test: Exercise tolerance test; Other: Physical activity & heart rate monitoring

Interventions

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)

Affected; Unaffected

Physical activity & heart rate monitoring OTHER

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.

Affected; Unaffected

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (2)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

RECRUITING

Royal Brompton Hospital

Sutton, SW36NP, United Kingdom

RECRUITING

Related Publications (19)

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• 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.

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MeSH Terms

Conditions

Long QT Syndrome; Polymorphic Catecholaminergic Ventricular Tachycardia; Motor Activity

Interventions

Exercise Test; Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Tachycardia; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Catherine E Renwick

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine E Renwick

CONTACT

07968534941; c.renwick@rbht.nhs.uk

Ethaar El-Emire

CONTACT

0207 351 8109; E.El-Emir@rbht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nurse / HEE/NIHR Doctoral Clinical and Practitioner Academic Fellow

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: October 28, 2024
• Study Start: March 18, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)