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Exercise Prescription in Children With Hypertrophic Cardiomyopathy

Sponsor: Alder Hey Children's NHS Foundation Trust

NCT ID: NCT07595354

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Exercise Prescription (behavioural)
How long the study runs
Study runs about 20 months (dates as stated)
About the drug or intervention
Exercise Prescription — behavioural: After a thorough clinical assessment, an Individualised Exercise Prescription (IEP) will be provided by a specialised physiotherapist.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
10 Years to 18 Years
Who
All
Number of participants
10
Started
2025-12-24
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for hypertrophic cardiomyopathy without obstruction
  • • NA - 10 participants
  • • Hypertrophic Cardiomyopathy (HCM) is an inherited cardiac condition that affects the heart muscle of adults and children

Who can take part?

  • • Ages 10 Years to 18 Years
  • • Diagnosed with hypertrophic cardiomyopathy without obstruction

Where?

  • • Liverpool - Alder Hey Children's Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Hypertrophic Cardiomyopathy (HCM) is an inherited cardiac condition that affects the heart muscle of adults and children. Historically, doctors have been cautious about encouraging patients with HCM to exercise, as they were worried it could be unsafe due to the risk of heart problems or emergencies. But recent evidence shows that the risks of exercise for a patient with HCM are far lower than previously thought and exercise has many benefits for a child's general health and mental well-being and is an important part of their social development. One way to help children with HCM feel confident to exercise is with an individualised exercise 'prescription'. This is where a team of specialist doctors, nurses, and physiotherapists assess patients and advise them on how to exercise safely and effectively. They then provide an exercise plan or 'prescription' individualised to them. This study aims to establish whether the investigators can deliver an individualised exercise prescription (IEP) service for children with HCM who attend outpatient cardiology. A further aim is to see if children will want to take part and adhere to the IEP. In this study children aged 10 to 18 years old attending outpatient cardiology clinic at Alder Hey Children's Hospital (AHCH) under screening for HCM will be asked if they wish to take part in the study. Those who wish to take part will have extra appointments at AHCH, during which the investigators will measure their height and weight. They will also have other tests done like blood pressure, a cycle test, sit-to-stand test, measurement of their hamstring flexibility and an ultrasound measure of their thigh muscle. The participants will be asked to complete a questionnaire about their quality of life. The participants will then be given an individualised exercise plan. In the first month, they will be given a supervised exercise session and asked to record their activity levels in an exercise log. The participants will have either a monthly telephone call or a face-to-face visit to see how they are getting on. After 6 months, all the initial tests will be repeated. The investigators will look at the data to see if the exercise prescription was helpful, if children could stick to it and if there have been improvements in their fitness and quality of life. Finally, the investigators will see them again six months later to see if the IEP programme has had a lasting impact on their exercise levels, fitness, and well-being.

Hypertrophic Cardiomyopathy Without Obstruction

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 10 Years - 18 Years
  • Who can join: All genders

What the study is looking for

  • ✓Undergoing screening for HCM due to a family history or gene-positive
  • ✓Aged 10 to 18 years (inclusive)
  • ✓Known to the inherited heart conditions clinic at Alder Hey Children's Hospital
  • ✓Normal heart function
  • ✓Able to complete an exercise log weekly with support from carers

Who cannot take part

  • ✗Moderate to severe co-morbidities, including neuromuscular and respiratory illness and conditions affecting mobility
  • ✗Learning difficulties precluding exercise participation
  • ✗Phenotype of HCM
  • ✗History of exercise-induced arrhythmia and/or syncope
  • ✗History of unexplained syncope
See the full criteria
Inclusion Criteria: * Undergoing screening for HCM due to a family history or gene-positive * Aged 10 to 18 years (inclusive) * Known to the inherited cardiac conditions clinic at Alder Hey Children's Hospital * Normal cardiac function * Able to complete an exercise log weekly with support from carers * Child or carer able to participate in telephone follow-up Exclusion Criteria: * Moderate to severe co-morbidities, including neuromuscular and respiratory illness and conditions affecting mobility * Learning difficulties precluding exercise participation * Phenotype of HCM * History of exercise-induced arrhythmia and/or syncope * History of unexplained syncope * Patients with an implantable cardiac defibrillator (ICD) * Family History of sudden cardiac death in first-degree relative * Child or carer unable to comply with telephone follow-up

Where Is This Study? (1 UK site)

Alder Hey Children's Hospital

Liverpool, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Sophia Khan, MbChB MD(Res)

Sponsor contact

CONTACT

=447557356755 sophia.khan@alderhey.nhs.uk

Lora Capobianco, PhD., CPsychol

Sponsor contact

CONTACT

lora.capobianco@manchester.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-04