Structured Exercise Training in Idiopathic Pulmonary Fibrosis

• Research type

  Research Study

• Full title

  Investigating the Effects of a Structured Responsive Exercise Training Programme in Idiopathic Pulmonary Fibrosis – a Pilot Study

• IRAS ID

  229497

• Contact name

  Timothy Wallis

• Contact email

  Tim.Wallis@uhs.nhs.uk

• Sponsor organisation

  UHS

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease characterised by exercise intolerance and breathlessness. In 2012 there were 32 500 people living in the UK with IPF. Average life expectancy from time of diagnosis is 2-3 years. Despite recent advances in drug-therapy, no medication has been shown to halt disease progression.

  Pulmonary Rehabilitation (PR) is a structured exercise and education intervention that is well established in Chronic Obstructive Pulmonary Disease. Current limited evidence shows that PR is safe in patients with IPF and leads to short-term improvements in exercise tolerance and quality of life. However, the optimal exercise protocol, the longer-term benefits and which group or patients benefit most is unclear, and further quality research is needed to clarify these issues. Further it is unknown what patho-physiological mechanisms underlie any improvement.

  Aims: This pilot study aims to determine whether a Structured Responsive Exercise Training Programme (SRETP) for patients with IPF
  i) Is feasible, safe and tolerable
  ii) To reconfirm that exercise training leads to improvement in exercise tolerance, symptoms and health related quality of life scores in IPF
  iii) Is able to aid identification of the potential mechanisms behind this, which will then be further elucidated in a fully powered, RCT.

  Study Design: Single center cohort pilot study located at a NHS Foundation trust teaching hospital. Interim analysis will be performed throughout the study.

  We aim to recruit 6-10 patients with a confirmed diagnosis of IPF aged 18-85 years with Medical Research Council (MRC) Breathlessness score 1-3

  Intervention
  An 8-week, twice weekly, STREP.

  Outcomes
  a. Primary: endurance time on a fixed load static cycling test
  b. Secondary: 6 minute walk test, outputs from Cardiopulmonary exercise testing (CPET), pulmonary function tests and validated health and symptom questionnaires
  c. Exploratory: pre and post intervention blood markers of disease activity, markers of oxidative stress and gene analysis

  End Points: adherence > 66%, adverse events

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  17/SC/0342

• Date of REC Opinion

  21 Jul 2017

• REC opinion

  Favourable Opinion