Exercise Prescription in Children With Hypertrophic Cardiomyopathy (Empower)

May 12, 2026 updated by: Alder Hey Children's NHS Foundation Trust

Effects of Exercise Prescription on Cardiovascular Health and Quality of Life 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Prescription Intervention
Behavioral: Exercise Prescription

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
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.
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
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).
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
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.
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
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.
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
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
Baseline, 6 month follow up (post treatment), and 12 months follow up.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiography
Time Frame: Baseline
Performed to confirm phenotype-negative status. If not completed within the previous 3 months, these are conducted at Visit 0.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alder Hey Children's NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS355645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Feasibility Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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