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
Authors: Wainwright, T.W. et al.
Journal: Lancet Rheumatology
Volume: 7
Issue: 11
Pages: e764-e775
eISSN: 2665-9913
DOI: 10.1016/S2665-9913(25)00102-X
Abstract:Background Osteoarthritis of the hip is a leading cause of chronic disability. The cycling and education intervention (CLEAT) trial aimed to compare the clinical and cost-effectiveness of the cycling against hip pain (CHAIN) intervention, a group-based cycling and education programme, with usual physiotherapy care for patients with hip osteoarthritis referred for physiotherapy at a UK hospital. Methods CLEAT was a pragmatic, single-centre, randomised controlled trial done in Bournemouth, UK. Patients older than 18 years with activity-related joint pain, either no morning stiffness or morning stiffness lasting no longer than 30 min, and who met the primary-care criteria for exercise referral were eligible to participate. Patients aged 18–45 years were only eligible to participate if an x-ray confirmed the presence of hip osteoarthritis. Participants were randomly assigned (1:1) to either the CHAIN intervention or usual physiotherapy care using random permuted blocks of sizes 2, 4, and 6. Participants in the CHAIN intervention group attended an 8-week group programme at a local leisure centre comprised of education and static cycling. Participants in the physiotherapy group had usual one-to-one care with a physiotherapist at the local hospital or by telephone, depending on usual care at the time of treatment. The primary outcome was the difference in Hip Disability and Osteoarthritis Outcome Score (HOOS) activities of daily living subscale at 10 weeks post-treatment (visit 4) between groups. The trial included a parallel economic evaluation from the primary perspective of the UK NHS and personal social services. All participants who provided data at visit 4 were included in the efficacy analysis, and data on safety and adverse events were collected between baseline and visit 4. People with lived experience of hip osteoarthritis were involved in the design and management of the study. This trial is registered with ISRCTN (ISRCTN19778222). Findings Between Feb 24, 2020, and April 28, 2023, 221 participants were recruited to the study and randomly assigned to the CHAIN intervention (110 [50%]) or usual physiotherapy care (111 [50%]). 126 (57%) participants were female, 95 (43%) were male, 217 (98%) were White, and the mean age was 64·4 years (SD 9·5). Participants in the CHAIN group had greater improvements in mean HOOS activities of daily living subscale scores (from 60·8 [SD 19·2] at baseline to 73·5 [20·0] at 10 weeks) compared with participants in the usual physiotherapy care group (from 59·3 [19·6] to 65·4 [19·9]; adjusted mean difference 6·9 [95% CI 2·5–11·2]; p=0·0023). Although the primary outcome showed a statistically significant improvement for CHAIN over usual physiotherapy, the between-group difference of 6·9 HOOS points did not meet the pre-defined minimum clinically important difference of 7·4. CHAIN cost £4092 per quality-adjusted life year gained compared with usual physiotherapy care, below the £20 000 to £30 000 National Institute of Health and Care Excellence threshold for cost-effectiveness. There were no treatment-related serious adverse events. Interpretation The CHAIN intervention showed superior outcomes compared with usual physiotherapy care, and the feasibility of delivering a low-cost, community-based intervention within the NHS was shown. However, longer-term benefits and broader generalisability warrant further investigation. Funding The National Institute for Health and Care Research for Patient Benefit Programme.
https://eprints.bournemouth.ac.uk/41074/
Source: Scopus
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.
Authors: Wainwright, T.W. et al.
Journal: Lancet Rheumatol
Volume: 7
Issue: 11
Pages: e764-e775
eISSN: 2665-9913
DOI: 10.1016/S2665-9913(25)00102-X
Abstract:BACKGROUND: Osteoarthritis of the hip is a leading cause of chronic disability. The cycling and education intervention (CLEAT) trial aimed to compare the clinical and cost-effectiveness of the cycling against hip pain (CHAIN) intervention, a group-based cycling and education programme, with usual physiotherapy care for patients with hip osteoarthritis referred for physiotherapy at a UK hospital. METHODS: CLEAT was a pragmatic, single-centre, randomised controlled trial done in Bournemouth, UK. Patients older than 18 years with activity-related joint pain, either no morning stiffness or morning stiffness lasting no longer than 30 min, and who met the primary-care criteria for exercise referral were eligible to participate. Patients aged 18-45 years were only eligible to participate if an x-ray confirmed the presence of hip osteoarthritis. Participants were randomly assigned (1:1) to either the CHAIN intervention or usual physiotherapy care using random permuted blocks of sizes 2, 4, and 6. Participants in the CHAIN intervention group attended an 8-week group programme at a local leisure centre comprised of education and static cycling. Participants in the physiotherapy group had usual one-to-one care with a physiotherapist at the local hospital or by telephone, depending on usual care at the time of treatment. The primary outcome was the difference in Hip Disability and Osteoarthritis Outcome Score (HOOS) activities of daily living subscale at 10 weeks post-treatment (visit 4) between groups. The trial included a parallel economic evaluation from the primary perspective of the UK NHS and personal social services. All participants who provided data at visit 4 were included in the efficacy analysis, and data on safety and adverse events were collected between baseline and visit 4. People with lived experience of hip osteoarthritis were involved in the design and management of the study. This trial is registered with ISRCTN (ISRCTN19778222). FINDINGS: Between Feb 24, 2020, and April 28, 2023, 221 participants were recruited to the study and randomly assigned to the CHAIN intervention (110 [50%]) or usual physiotherapy care (111 [50%]). 126 (57%) participants were female, 95 (43%) were male, 217 (98%) were White, and the mean age was 64·4 years (SD 9·5). Participants in the CHAIN group had greater improvements in mean HOOS activities of daily living subscale scores (from 60·8 [SD 19·2] at baseline to 73·5 [20·0] at 10 weeks) compared with participants in the usual physiotherapy care group (from 59·3 [19·6] to 65·4 [19·9]; adjusted mean difference 6·9 [95% CI 2·5-11·2]; p=0·0023). Although the primary outcome showed a statistically significant improvement for CHAIN over usual physiotherapy, the between-group difference of 6·9 HOOS points did not meet the pre-defined minimum clinically important difference of 7·4. CHAIN cost £4092 per quality-adjusted life year gained compared with usual physiotherapy care, below the £20 000 to £30 000 National Institute of Health and Care Excellence threshold for cost-effectiveness. There were no treatment-related serious adverse events. INTERPRETATION: The CHAIN intervention showed superior outcomes compared with usual physiotherapy care, and the feasibility of delivering a low-cost, community-based intervention within the NHS was shown. However, longer-term benefits and broader generalisability warrant further investigation. FUNDING: The National Institute for Health and Care Research for Patient Benefit Programme.
https://eprints.bournemouth.ac.uk/41074/
Source: PubMed
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
Authors: Wainwright, T. et al.
Journal: The Lancet Rheumatology
eISSN: 2665-9913
ISSN: 2665-9913
DOI: 10.1016/S2665-9913(25)00102-X
https://eprints.bournemouth.ac.uk/41074/
Source: Manual
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.
Authors: Wainwright, T.W. et al.
Journal: The Lancet. Rheumatology
Volume: 7
Issue: 11
Pages: e764-e775
eISSN: 2665-9913
ISSN: 2665-9913
DOI: 10.1016/s2665-9913(25)00102-x
Abstract:Background
Osteoarthritis of the hip is a leading cause of chronic disability. The cycling and education intervention (CLEAT) trial aimed to compare the clinical and cost-effectiveness of the cycling against hip pain (CHAIN) intervention, a group-based cycling and education programme, with usual physiotherapy care for patients with hip osteoarthritis referred for physiotherapy at a UK hospital.Methods
CLEAT was a pragmatic, single-centre, randomised controlled trial done in Bournemouth, UK. Patients older than 18 years with activity-related joint pain, either no morning stiffness or morning stiffness lasting no longer than 30 min, and who met the primary-care criteria for exercise referral were eligible to participate. Patients aged 18-45 years were only eligible to participate if an x-ray confirmed the presence of hip osteoarthritis. Participants were randomly assigned (1:1) to either the CHAIN intervention or usual physiotherapy care using random permuted blocks of sizes 2, 4, and 6. Participants in the CHAIN intervention group attended an 8-week group programme at a local leisure centre comprised of education and static cycling. Participants in the physiotherapy group had usual one-to-one care with a physiotherapist at the local hospital or by telephone, depending on usual care at the time of treatment. The primary outcome was the difference in Hip Disability and Osteoarthritis Outcome Score (HOOS) activities of daily living subscale at 10 weeks post-treatment (visit 4) between groups. The trial included a parallel economic evaluation from the primary perspective of the UK NHS and personal social services. All participants who provided data at visit 4 were included in the efficacy analysis, and data on safety and adverse events were collected between baseline and visit 4. People with lived experience of hip osteoarthritis were involved in the design and management of the study. This trial is registered with ISRCTN (ISRCTN19778222).Findings
Between Feb 24, 2020, and April 28, 2023, 221 participants were recruited to the study and randomly assigned to the CHAIN intervention (110 [50%]) or usual physiotherapy care (111 [50%]). 126 (57%) participants were female, 95 (43%) were male, 217 (98%) were White, and the mean age was 64·4 years (SD 9·5). Participants in the CHAIN group had greater improvements in mean HOOS activities of daily living subscale scores (from 60·8 [SD 19·2] at baseline to 73·5 [20·0] at 10 weeks) compared with participants in the usual physiotherapy care group (from 59·3 [19·6] to 65·4 [19·9]; adjusted mean difference 6·9 [95% CI 2·5-11·2]; p=0·0023). Although the primary outcome showed a statistically significant improvement for CHAIN over usual physiotherapy, the between-group difference of 6·9 HOOS points did not meet the pre-defined minimum clinically important difference of 7·4. CHAIN cost £4092 per quality-adjusted life year gained compared with usual physiotherapy care, below the £20 000 to £30 000 National Institute of Health and Care Excellence threshold for cost-effectiveness. There were no treatment-related serious adverse events.Interpretation
The CHAIN intervention showed superior outcomes compared with usual physiotherapy care, and the feasibility of delivering a low-cost, community-based intervention within the NHS was shown. However, longer-term benefits and broader generalisability warrant further investigation.Funding
The National Institute for Health and Care Research for Patient Benefit Programme.https://eprints.bournemouth.ac.uk/41074/
Source: Europe PubMed Central
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
Authors: Wainwright, T.W. et al.
Journal: The Lancet Rheumatology
ISSN: 2665-9913
Abstract:Background. Osteoarthritis (OA) of the hip is a leading cause of chronic disability. The CLEAT trial compared the clinical and cost-effectiveness of CHAIN, a group-based cycling and education programme, with usual physiotherapy care for patients with hip OA referred for physiotherapy at a UK hospital.
Methods. This pragmatic, single-centre randomised controlled trial randomised participants 1:1 to the 8-week CHAIN intervention or usual physiotherapy care. The primary outcome was the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities of Daily Living (ADL) subscale post-treatment. The trial included a parallel economic evaluation from the primary perspective of the UK NHS and personal social services. People with lived experience were involved in the design and management of the study. Trial registration: ISRCTN19778222.
Findings. We recruited 221 participants and included in the analysis (126 females; mean age 64·4 (SD 9·54) years), 110 to CHAIN and 111 to usual physiotherapy care. CHAIN participants showed statistically significantly greater improvements in the HOOS ADL subscale post treatment (adjusted mean difference: 6·9 [95% CI 2·5 to 11·2, p=0·002]) compared to usual physiotherapy care. There were no treatmentrelated serious adverse events. CHAIN cost £4,092 per QALY gained compared to usual physiotherapy care, below the £20,000–£30,000 National Institute of Health and Care Excellence (NICE) threshold for cost-effectiveness.
Interpretation. Post-treatment, CHAIN demonstrated superior outcomes compared to usual physiotherapy care, and the feasibility of delivering a low-cost, community-based intervention within the NHS was shown. However, longer-term benefits and broader generalisability warrant further investigation.
Funding. The National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0816-20033).
https://eprints.bournemouth.ac.uk/41074/
Source: BURO EPrints