Exercise Prescription in Children With Hypertrophic Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorAlder Hey Children's NHS Foundation Trust
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Exercise Prescription
BehavioralAfter 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Exercise Prescription InterventionExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.Secondary outcomes
1
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.
Time frame
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.2
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.
Time frame
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.3
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).
Time frame
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.4
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.
Time frame
Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.Other outcomes
1
Echocardiography
Performed to confirm phenotype-negative status. If not completed within the previous 3 months, these are conducted at Visit 0.
Time frame
Baseline2
Electrocardiogram (ECG)
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov