PORIAS-HF

  • Research type

    Research Study

  • Full title

    Pilot testing of an online rehabilitation intervention aiming to support people with heart failure.

  • IRAS ID

    294411

  • Contact name

    Markos Klonizakis

  • Contact email

    m.klonizakis@shu.ac.uk

  • Sponsor organisation

    Sheffield Hallam University

  • Clinicaltrials.gov Identifier

    NCT04797481

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    0 years, 10 months, 0 days

  • Research summary

    The inability of the heart to pump out blood to the rest of the body organs is called heart failure (HF). HF affects almost 920,000 people in the UK, costing the NHS up to £2.33bn/year. Physical exercise programmes aiming to improve the heart's ability to pump out blood are used to a) reduce the risk of life-threatening events (e.g., heart attack), b) reduce admissions to hospital and c) improve individual's physical independence (e.g., walking unsupported, being able to perform daily essential activities). However, these physical exercise programmes have been cut short under the current COVID-19 pandemic, with support in most UK regions being restricted to online videos and advice. With many people with HF being asked to be “shielded” or “self-isolate” for an unknown duration, it is important to develop a reliable and cost-effective physical exercise service to support this clinical group. Our team has developed a novel physical exercise programme, fully-delivered online. Before assessing if it could improve clinical outcomes (e.g., heart's ability to pump out blood) and how cost-effective it could be, we propose a 10-month pilot study that will assess if the proposed online physical exercise programme could be performed in people with HF. 24-30 participants will be allocated at random into two groups: Group A will receive up to 24 exercise sessions and up-to 3 lifestyle workshops, in addition to usual care over a 2-month period. Group B will receive a self-care exercise programme (≥3 sessions per week) for a two-month period in addition to usual care. Prior to the group random allocation, online assessments will be performed including demographics and clinical history, the ability to perform daily activities, sedentary or physical activity habits and quality of life. The assessments including interviews to assess participant's experiences will be repeated at 2 months.

  • REC name

    West Midlands - Black Country Research Ethics Committee

  • REC reference

    21/WM/0056

  • Date of REC Opinion

    19 Mar 2021

  • REC opinion

    Further Information Favourable Opinion