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Exercise Prescription in Children With Hypertrophic Cardiomyopathy (Empower)

12 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

10

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Exercise Prescription Intervention
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Recruitment Rate (Feasibility and Acceptability) of IEP
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pediatric Quality of Life (PedsQoL)
Ramy czasowe: 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.
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Echocardiography
Ramy czasowe: Baseline
Performed to confirm phenotype-negative status. If not completed within the previous 3 months, these are conducted at Visit 0.
Baseline
Electrocardiogram (ECG)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Alder Hey Children's NHS Foundation Trust

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

24 grudnia 2025

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

22 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRAS355645

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Feasibility Study

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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