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NCT Number: NCT07595354

Exercise Prescription in Children With Hypertrophic Cardiomyopathy

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy Without Obstruction Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alder Hey Children's Hospital

Liverpool, United Kingdom

Location status: Recruiting

Location contact

Becky Taylor

CONTACT

[email protected]

+441512525715

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Rate (Feasibility and Acceptability) of IEP

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

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

Secondary outcomes

  1. Pediatric Quality of Life (PedsQoL)

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

    The PedsQol is a 23 item measures of health related quality of life, and includes four subscales: physical, emotional, social and school functioning. The questionnaire is commonly used in paediatric cardiology. The PedsQol will be completed by CYP.

    The items are scores from 0 (Never) to 4 (Almost always). Total scores range from 0-100, with higher scores indicating better quality of life.

  2. Improvement in the participant's cardiovascular fitness.

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

    Cardiovascular fitness assessed by cardiopulmonary exercise test. A cycle CPET using the Godfrey Protocol will be conducted. Standard CPET data will be reported including VO2, V02 peak, Heart Rate, Blood Pressure.

  3. Hamstring Flexibility (Length of reach in cm)

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

    A passive knee extension test (supine). The hip is stabilised at 90°, and the knee is extended to the first stretch sensation. The popliteal angle is measured via goniometer (mean of three readings per leg).

  4. Sit to Stand Test (Total number of repetitions)

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

    Participants stand from a chair (placed against a wall) to full extension and sit back down as many times as possible in 60 seconds without using arms. HR and SpO2 are recorded pre- and post-test.

  5. Muscle Morphology (Quadriceps femoris)

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

    The widest portion of the thigh (measured from the superior patellar border). QF anterior thickness is the sum of Vastus Intermedius (Vi) and Rectus Femoris (RF) thicknesses. Four measurements (two transverse, two longitudinal) are averaged. RF cross-sectional area is also recorded.

  6. Demographics Questionnaire

    Time frame: Baseline, 6 month follow up (post treatment), and 12 months follow up.

    The demographics questionnaire will collect variables such as participants age, sex, weight, height, type of heart problems, and ethnicity

Other outcomes

  1. Echocardiography

    Time frame: Baseline

    Performed to confirm phenotype-negative status. If not completed within the previous 3 months, these are conducted at Visit 0.

  2. Electrocardiogram (ECG)

    Time frame: Baseline

    Performed to confirm normal sinus rhythm with normal voltages and repolarisation. If not completed within the previous 3 months, these are conducted at Visit 0.

Study contacts

Contact information is provided by the study sponsor or research team.

Lora Capobianco, PhD., CPsychol

CONTACT

[email protected]

Sophia Khan, MbChB MD(Res)

CONTACT

[email protected]

=447557356755

Sponsors and collaborators

Lead sponsor

Alder Hey Children's NHS Foundation Trust

Other

Registry information

Official study title

Effects of Exercise Prescription on Cardiovascular Health and Quality of Life in Children With Hypertrophic Cardiomyopathy

Acronym: Empower

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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