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临床试验/NCT07595354
NCT07595354招募中不适用

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

Alder Hey Children's NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年12月24日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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