Exercise Prescription in Children With Hypertrophic Cardiomyopathy

NCT07595354 | Recruiting

• 1 other identifier: IRAS355645
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy Without Obstruction

Keywords

Exercise Prescription; Feasability; Hypertrophic Cardiomyopathy; Children

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate (Feasibility and Acceptability) of IEP

  Feasibility will be assessed using recruitment rate (i.e., number of patients consented and number of patients declined the study).

  Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.

Secondary Outcomes (6)

• Pediatric Quality of Life (PedsQoL)

  Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.

• Improvement in the participant's cardiovascular fitness.

  Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.

• Hamstring Flexibility (Length of reach in cm)

  Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.

• Sit to Stand Test (Total number of repetitions)

  Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.

• Muscle Morphology (Quadriceps femoris)

  Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.

Other Outcomes (2)

• Echocardiography

  Baseline

• Electrocardiogram (ECG)

  Baseline

Study Arms (1)

Exercise Prescription Intervention

EXPERIMENTAL

Behavioral: Exercise Prescription

Interventions

Exercise Prescription BEHAVIORAL

After a thorough clinical assessment, an Individualised Exercise Prescription (IEP) will be provided by a specialised physiotherapist. The physiotherapy team, who will complete a retrospective baseline exercise log from the preceding week with the participant . The physiotherapist will then perform a sit-to-stand test, a hamstring flexibility test, and an ultrasound of the quadriceps on the participant. The participant will also complete a standardised quality-of-life questionnaire. After this, the physiotherapy team will provide the participant with an IEP for them to follow at home. This EP will be supervised by parents or guardians, based on the exercise log and baseline test results, and will vary in intensity and length of exercise to be achievable. The IEP will be a 6-month programme with regular monthly contact with the study team to monitor progress and then a further 12-month follow-up visit. Contact will be either face to face appointments or telephone calls.

Exercise Prescription Intervention

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (1)

Alder Hey Children's Hospital

Liverpool, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Sophia Khan, MbChB MD(Res)

CONTACT

=447557356755; sophia.khan@alderhey.nhs.uk

Lora Capobianco, PhD., CPsychol

CONTACT

lora.capobianco@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 19, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)