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Exercise Prescription in Children With Hypertrophic Cardiomyopathy (Empower)

12 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Exercise Prescription Intervention
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment Rate (Feasibility and Acceptability) of IEP
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pediatric Quality of Life (PedsQoL)
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Echocardiography
Lasso di tempo: Baseline
Performed to confirm phenotype-negative status. If not completed within the previous 3 months, these are conducted at Visit 0.
Baseline
Electrocardiogram (ECG)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alder Hey Children's NHS Foundation Trust

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 dicembre 2025

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

22 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRAS355645

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Feasibility Study

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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