CLEAT: a cycling and education programme in the treatment of hip OA
Research type
Research Study
Full title
A pragmatic 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
IRAS ID
232991
Contact name
Thomas W. Wainwright
Contact email
Sponsor organisation
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN19778222
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Over 2 million people have hip osteoarthritis in the UK. Hip osteoarthritis can cause pain and interfere with many usual daily activities. The latest NICE guidance on the treatment of osteoarthritis recommends exercise, education and weight loss, if indicated. Cycling strengthens muscles around the hip and is an excellent form of low impact exercise.
This study will compare the effectiveness of an eight-week static-cycling and educational programme with usual physiotherapy care for the treatment of hip osteoarthritis. Patients’ ability to complete activities of daily living, pain levels, and quality of life will be compared and cost-effectiveness assessed.
Male and female individuals aged 45 and over with hip pain and/or with a diagnosis of osteoarthritis of the hip who have been referred for Physiotherapy treatment will be potentially eligible to take part.
Once approvals have been given and informed consent received, participants will undergo baseline assessment to ensure that they are suitable to take part. If eligible, participants will be randomly allocated to either take part in a cycling/educational programme or receive usual physiotherapy care. Participants on the cycling/educational programme will attend a one-hour session once a week for eight weeks at a local leisure centre. Participants in the usual care group will receive usual physiotherapy care.
As well as a baseline assessment prior to the treatment, participants will also be assessed once they have competed treatment. These assessments will include measures of function, hip pain, quality of life, attitudes to managing hip osteoarthritis, relevant medications use and costs of care. After six months participants will be asked to complete some of the same questionnaires from their previous assessments relating to their symptoms, pain, ability to perform daily tasks, quality of life and resource use. In total, 256 participants will be involved in this study.
Lay summary of study results:Over 3 million people have hip osteoarthritis in the UK. Hip osteoarthritis can cause pain and interfere with many usual daily activities. The latest NICE guidance on the treatment of osteoarthritis recommends muscle strengthening, exercise, and education and advice on managing osteoarthritis. Cycling strengthens muscles around the hip and is an excellent form of low impact exercise.
This study compared an eight-week cycling exercise and educational programme (CHAIN) with usual physiotherapy care for the treatment of hip osteoarthritis. Patients’ ability to complete daily activities, pain levels, and quality of life were compared, and cost-effectiveness assessed before treatment began, at the end of treatment, and 3 months later.
Two hundred and twenty-one patients were randomly allocated to receive either CHAIN or physiotherapy. Participants assigned to CHAIN were given 30 mins education and 30 minutes on a static bike each week at a leisure centre. Those assigned to physiotherapy received up to four sessions. People who participated in a smaller-scale version of the programme helped design the research. A small group went on advise on how to deliver the study and share findings.
The study found that people reported improvements in undertaking everyday activities, pain levels and quality of life for both CHAIN and usual physiotherapy care. However, those who had CHAIN reported a greater improvement in undertaking everyday activities, pain and quality of life when tested after treatment, compared to those who had physiotherapy. Both groups reported a reduction in the improvements three months after treatment finished. No differences between the groups were found for performance and physiology tests. The CHAIN intervention was found to be cost-effective when compared to usual physiotherapy care.
Findings are being shared with patients, the public, professional colleagues and policy makers through conferences, publications, a website and an app which enables people to do CHAIN virtually.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
19/SC/0502
Date of REC Opinion
14 Oct 2019
REC opinion
Favourable Opinion