Title: A pragmatic multi-centred randomised controlled trial with economic evaluation, to compare a cycling and educational programme with usual physiotherapy care in the treatment of hip osteoarthritis: CycLing and EducATion (CLEAT)
Funder: Department of Health and Social Care

Abstract: Background to the research Around a third of people aged over 45 years in the UK (8.75 million) have sought treatment for osteoarthritis, and 2.12 million for hip osteoarthritis8. Over 17 million people are expected to be living with osteoarthritis by 20309. Hip osteoarthritis is associated with hip pain, stiffness, and dysfunction in activities of daily living. National Institute for Health and Care Excellence (NICE) guidance10 for the care and management of osteoarthritis recommends three core treatments; education and self-management, exercise (specifically local muscle strengthening and general aerobic fitness) and interventions to achieve weight loss where necessary. Currently, physiotherapy services offer varying programmes of treatment but are often no more effective than placebo16. Cycling is a healthy form of physical activity26 and a non-weight bearing activity that is considered less stressful on the body than impact or other running sports27. Cycle training induces muscle hypertrophy, with increased strength gains seen more favourably in older adults24. In the downstroke of cycling, the hip, knee and ankle joints extend simultaneously for the pushing action25 and as such cycling is an excellent method of addressing and improving extension impairments in the hip, knee and ankle joints. Aims To investigate the effectiveness and cost-effectiveness of a cycling and educational intervention compared to usual physiotherapy care to manage symptoms of hip osteoarthritis in over 45 year olds. The objectives are to investigate whether there are differences in function, hip pain, quality of life, attitudes to managing hip osteoarthritis and psychological wellbeing, between those who receive the intervention and those who receive usual physiotherapy care, and to assess the cost effectiveness of the intervention compared to usual care. Plan of investigation 256 people with hip osteoarthritis will be recruited from physiotherapy services in Dorset. Participants will be randomised to receive usual physiotherapy care or a cycling, exercise and education intervention. Those in the intervention group will attend an exercise and education class once a week for eight weeks at a leisure centre. Each session consists of an education talk, and an indoor stationary cycling exercise class. A home-based exercise programme will also be prescribed, and plans for lifestyle changes and on-going exercise will be made. The usual physiotherapy care will be semi-standardised and will comprise core components plus optional techniques and exercises depending on assessment findings. All participants will receive 4-6 home exercises and advice. Information from patient notes on the exact treatment and number of sessions delivered will be recorded. Potential benefits to patients and the NHS The feasibility work completed has found that the cycling and exercise programme is very effective at improving patient symptoms.12 Given the current number of people with hip osteoarthritis, the aging population, and the need to provide treatment in accordance with NICE guidelines, the cycling and exercise intervention provides potential cost and capacity benefits. In the intervention group, the physiotherapist can see 15 patients in 8 hours, compared to standard care, where in the same hours they would see 4 patients. Seeing 11 more patients will help in capacity and reduce waiting times for physiotherapy. The potential to prevent the need for hip replacement is highly significant. Ninety percent of primary hip replacement patients have a diagnosis of osteoarthritis59 and in 2015, costs for primary hip replacements in England, Wales and Northern Ireland were in the region of &pound;530 million59 62 (approx 89,300 procedures at &pound;5,884 each).

Lay abstract: Background Over two million people have arthritis of the hip in the UK, and many may have pain and interference to their activities. Some need hip replacements which are invasive and costly. As our population ages, this will affect more people. Treatments are required which offer value for money. Exercise can improve people s ability to do everyday activities, whilst also reducing their pain and need for surgery. Aims This study will compare a group of hip arthritis patients taking part in a cycling/advice programme with a group having usual physiotherapy treatment, to see if their ability to do everyday activities improves. Design and methods used Two-hundred-and-fifty-six patients will take part, having been referred by GPs or hospital consultants. Patients who take part in the cycling/advice programme will attend a local leisure centre for one hour a week over eight weeks. In each session they will receive 30 minutes advice from a physiotherapist on how to manage their arthritis, and 30 minutes using a static bike. Patients who are in the physiotherapy group will have usual physiotherapy treatment which is likely to be around 3 &ndash; 5 treatment sessions at their local hospital. At the start and end of treatment, we will measure patients activity levels, pain, and quality of life. The results from two groups will then be compared. Six months after treatment we will assess whether the cycling/advice group are more likely to keep up their increased activity; and which group offers the better value for money. Patient and public involvement People who participated in a smaller-scale version of the cycling/advice programme helped design this study, and will assist in running and managing the study. Dissemination The findings will be presented at international conferences, published in medical journals, posted on social media, and put on a dedicated website.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL