The ACTIVELY Study

  • Research type

    Research Study

  • Full title

    Observational, prospective, cross sectional, multicentre study for evaluation of free-living physical activity and the assessment tools used to support pharmacological therapy titration and exercise prescription in children and adolescents diagnosed with inherited arrhythmias.

  • IRAS ID

    341211

  • Contact name

    Catherine E Renwick

  • Contact email

    c.renwick@rbht.nhs.uk

  • Sponsor organisation

    Guy's and St Thomas' NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    Exercise tolerance testing (ETT) using an exercise treadmill is used to assess children’s physical response to stress and is thought to accurately reflect normal physiology during daily activities.

    The maximum heart rate (HR) achieved is used to estimate the effect of medications and guide exercise prescription in children diagnosed with inherited arrhythmias (IA).

    To accommodate children’s needs, shorter ETT protocols have been developed which increase the speed and/or incline of the treadmill. Despite this, many children rarely complete the full test. They grow tired or develop other symptoms, leading to them stopping testing early.

    Children naturally increase effort during daily physical activity (PA). Therefore, daily PA is thought to show a more accurate representation of the maximum HR (HRmax) children can achieve.

    The study aims to

    - Compare HRmax during ETT with the HRmax achieved during daily free living PA and exercise, to see if these are different.

    - Assess three different exercise testing protocols for children, and identify if one is better at estimating HRmax compared with PA.

    - Investigate the actual versus reported PA children engage in using a questionnaire and digital PA diary.

    Children aged 6-16 years diagnosed with an IA, who can run on an exercise treadmill, plus a healthy control group will be recruited.

    - A routine ETT will be performed.

    - Participants will wear a PA monitor to record PA over two-weeks. PA will also be recorded digitally to capture type and length of activity engaged in, and the estimated intensity.

    - At the end of the two-week monitoring period, participants will complete a PA questionnaire with results compared with data obtained during the monitoring period.

    A study lay advisory group will be established to advise on all aspects of the research cycle.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference

    24/PR/1000

  • Date of REC Opinion

    17 Sep 2024

  • REC opinion

    Further Information Favourable Opinion