Hypertrophic Cardiomyopathy Without ObstructionEmpowerNCT07595354
Exercise Prescription in Children With Hypertrophic Cardiomyopathy
A study testing Exercise Prescription in people with Hypertrophic Cardiomyopathy Without Obstruction, run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy Without Obstruction
- What is being tested?
- Exercise Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Dec 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lora Capobianco, PhD., CPsychol contact
United Kingdom1 site, 1 recruiting
- Recruiting
Alder Hey Children's Hospital
Liverpool
Becky Taylor, +441512525715, becky.taylor@alderhey.nhs.uk
About this study
Official title: 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.
Read more
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.
- Being tested
- Exercise Prescription
- Keywords
- Exercise Prescription, Feasability, Hypertrophic Cardiomyopathy, Children
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise PrescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Prescription Intervention | Experimental | Not described Receives: Behavioral: Exercise Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
Secondary outcomes (6)
Pediatric Quality of Life (PedsQoL)
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.
Measured: Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
Improvement in the participant's cardiovascular fitness.
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.
Measured: Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
Hamstring Flexibility (Length of reach in cm)
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).
Measured: Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
Sit to Stand Test (Total number of repetitions)
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.
Measured: Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
Muscle Morphology (Quadriceps femoris)
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.
Measured: Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.
Demographics Questionnaire
The demographics questionnaire will collect variables such as participants age, sex, weight, height, type of heart problems, and ethnicity
Measured: Baseline, 6 month follow up (post treatment), and 12 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start24 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy Without ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alder Hey Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595354
- Sponsor's protocol ID
- IRAS355645
- Acronym
- Empower
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Feasibility Study
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Prescription on Cardiovascular Health and Quality of Life in Children With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07595354
- Acronym / sponsor ID
- Empower / IRAS355645
- Keywords
- Exercise Prescription, Feasability, Hypertrophic Cardiomyopathy, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alder Hey Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Prescription Intervention | Experimental | Behavioral: Exercise Prescription |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise PrescriptionAfter 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. | Behavioural | Exercise Prescription Intervention |
Primary outcome
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).
6 secondary outcomes
Pediatric Quality of Life (PedsQoL)
Time frame: 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.
Hamstring Flexibility (Length of reach in cm)
Time frame: 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.
Muscle Morphology (Quadriceps femoris)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Feasibility Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lora Capobianco, PhD., CPsychol contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Prescription in people with Hypertrophic Cardiomyopathy Without Obstruction, run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Khan, MbChB MD(Res) (=447557356755, sophia.khan@alderhey.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (Feasibility and Acceptability) of IEP (time frame: Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.