The ON-PACE trial

  • Research type

    Research Study

  • Full title

    Dietary nitrate supplementation to enhance daily physical activity in hypoxic COPD: a randomised controlled trial

  • IRAS ID

    315107

  • Contact name

    Nicholas Hopkinson

  • Contact email

    n.hopkinson@ic.ac.uk

  • Sponsor organisation

    Imperial College London

  • ISRCTN Number

    ISRCTN12474100

  • Duration of Study in the UK

    3 years, 6 months, 1 days

  • Research summary

    We want to find out if taking a nutritional supplement, beetroot juice, is beneficial for people with the most severe form of chronic obstructive pulmonary disease (COPD). In this patient group, who have low oxygen levels, we will investigate whether the supplement can improve the amount of daily physical activity they can do and how hard they find it.
    COPD is a common lung condition, combining chronic bronchitis and emphysema which affects 1.3 million people in the UK. COPD causes breathlessness, cough and limits people’s ability to do daily activities like walking and housework.
    Beetroot juice is high in nitrate. The nitrate is absorbed and then broken down to nitric oxide (NO). Nitric oxide is an important molecule in the body. It influences how blood vessels work and how muscles use oxygen. We have shown that beetroot juice makes training programmes more effective in people with COPD and increases walking distance in hypoxic COPD patients.
    We will invite people with COPD who use oxygen at home to take part in a three month long clinical trial. Half will take 70mls beetroot juice each morning, the other half will consume an otherwise identical placebo beetroot juice drink from which the nitrate has been removed.
    The main outcome measure will be how difficult participants find physical activity, using a measure developed specially for COPD called the “PROactive physical activity in COPD tool”. This combines results from an activity monitor which participants wear for 7 days with a questionnaire about the amount and difficulty of daily activity. We will also measure exercise capacity directly using a timed walking test (the endurance shuttle walk test) and ask about general respiratory symptoms and if any complications have occurred.

  • REC name

    Wales REC 6

  • REC reference

    22/WA/0180

  • Date of REC Opinion

    24 Jun 2022

  • REC opinion

    Further Information Favourable Opinion