CLEAT

Study Description: The purpose of the CLEAT study is to investigate whether people who receive an 8 week education and static cycling treatment have an improvement in their hip function and less pain than those patients who receive physiotherapy treatment as per standard care and practice within the NHS.

Primary Objective: To determine whether there is a difference in self-reported function between those receiving the cycling and educational intervention compared to those with usual physiotherapy care.

Secondary Objectives: To determine whether there is a difference in self-reported hip pain, patient defined/observed function and activation levels (defined as the individual’s knowledge, skill and confidence to manage their own health) between those receiving the cycling/educational intervention compared to those with usual physiotherapy care. To estimate the resources used and costs of providing the cycling and educational intervention. To determine whether there is a difference in resources used, associated costs and quality of life between those receiving the cycling and educational intervention compared to those with usual physiotherapy care. To determine whether the cycling and educational intervention is cost-effective compared with usual physiotherapy care.

Results: 221 participants were recruited. Participants in the CHAIN group had greater improvements in mean Hip Disability and Osteoarthritis Outcome Score (HOOS) activities of daily living subscale scores compared with participants in the usual physiotherapy care group. CHAIN cost £4092 per quality-adjusted life year gained compared with usual physiotherapy care, below the £20,000 to £30,000 NICE threshold for cost-effectiveness.

Publications:

Wainwright TW, Immins T, Docherty S, et al. Clinical and cost-effectiveness of a cycling and education intervention versus usual physiotherapy care for the treatment of hip osteoarthritis in the UK (CLEAT): a pragmatic, randomised, controlled trial. The Lancet Rheumatology. 2025.

Registry Link:

ISRCTN – ISRCTN19778222: A cycling and education programme in the treatment of hip osteoarthritis