Exercise Prescription in Children With Hypertrophic Cardiomyopathy

Official title

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

Overview

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.

Interventions

• 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,

Primary outcome measures

• Recruitment Rate (Feasibility and Acceptability) of IEP [Time frame: Date of Baseline Assessment, 6 month follow up (post-treatment), and 12 month follow up.]

Secondary outcome measures (6)

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United Kingdom · 1 center

• Alder Hey Children's Hospital — Liverpool

Identifiers

NCT: NCT07595354 · IRAS355645

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗