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<p>This paper describes the challenges of undertaking a trial of a pre-operative lifestyle intervention in multiple surgical specialties, the INSPIRE trial, and additional challenges of doing so during the COVID-19 pandemic. The INSPIRE trial was a randomised controlled trial to test if inspiratory muscle training could reduce the incidence of postoperative pulmonary complications in patients undergoing cardiac, thoracic and abdominal elective surgery. We present the challenges of trial conduct alongside the adaptations introduced to mitigate the impact of those challenges. The INSPIRE trial was halted by the funder at the end of the internal pilot phase. We were therefore unable to assess the effect of some of the adaptations, and there were further adaptations we were unable to make. We are using our experience to make recommendations for future similar trials.</p>

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Challenges of delivering a lifestyle intervention before surgery in multiple surgical specialties in the NHS: experience from the INSPIRE trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月8日

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  • Emma Bridgeman,
  • Chloe Beard,
  • Katherine Joyce,
  • Denny Levett,
  • Dawn Phillips,
  • Maria Pufulete,
  • Lucy Culliford

摘要

This paper describes the challenges of undertaking a trial of a pre-operative lifestyle intervention in multiple surgical specialties, the INSPIRE trial, and additional challenges of doing so during the COVID-19 pandemic. The INSPIRE trial was a randomised controlled trial to test if inspiratory muscle training could reduce the incidence of postoperative pulmonary complications in patients undergoing cardiac, thoracic and abdominal elective surgery. We present the challenges of trial conduct alongside the adaptations introduced to mitigate the impact of those challenges. The INSPIRE trial was halted by the funder at the end of the internal pilot phase. We were therefore unable to assess the effect of some of the adaptations, and there were further adaptations we were unable to make. We are using our experience to make recommendations for future similar trials.