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A cycling and education programme in the treatment of hip osteoarthritis

A pragmatic randomised controlled trial with economic evaluation to compare a cycling and education programme with usual physiotherapy care in the treatment of hip osteoarthritis: CycLing and EducATion (CLEAT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19778222
Enrollment
256
Registered
2019-10-21
Start date
2020-01-29
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip osteoarthritis Musculoskeletal Diseases

Interventions

The study will use block randomisation. Each programme in the study will have up to 30 participants randomised to the intervention: the education and cycling programme, or routine physiotherapy care,

Sponsors

University Hospitals Dorset NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 08/11/2022: 1. Diagnosed with osteoarthritis of the hip as per OARSI criteria 2. Male and female, aged 18 years and over. If under 45, an x-ray confirming diagnosis of osteoarthritis is required. 3. Meeting the GP criteria for exercise referral (British Heart Foundation 2010) 4. Capable of giving informed consent 5. Willing to commit to the exercise intervention if randomised to the treatment arm. 6. Able to commit to the exercise intervention if randomised to the treatment arm as assessed by the physiotherapist after reviewing participant medical records at the baseline assessment 7. Be able to understand English as necessary to benefit from the intervention, in the investigators' opinion _____ Previous inclusion criteria: 1. Diagnosed with osteoarthritis of the hip as per OARSI criteria 2. Male and female, aged 45 years and over 3. Meeting the GP criteria for exercise referral (British Heart Foundation 2010) 4. Capable of giving informed consent 5. Willing to commit to the exercise intervention if randomised to the treatment arm. 6. Able to commit to the exercise intervention if randomised to the treatment arm as assessed by the physiotherapist after reviewing participant medical records at the baseline assessment 7. Be able to understand English as necessary to benefit from the intervention, in the investigators' opinion

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 08/11/2022: 1. Hip surgery within the last 6 months 2. On the waiting list for a hip replacement or planning back or lower limb surgery in the next 9 months 3. Current or past (within 3 months) intra-articular corticosteroid injection (or any other therapeutic injection) of the hip. 4. Due to the safety limitations of the static bikes used, participants need to be >=150cm tall and weight <=135kg. 5. Women who are pregnant and have not previously or are not currently exercising regularly to the equivalent of 30 minutes of static cycling per week 6. Judged by the investigator to have high levels of functional limitations which will prevent the participant from getting on and off the exercise bike _____ Previous exclusion criteria: 1. Hip surgery within the last 6 months 2. On the waiting list for a hip replacement or planning back or lower limb surgery in the next 9 months 3. Current or past (within 3 months) oral or intra-articular corticosteroid use 4. Women who are pregnant and have not previously or are not currently exercising regularly to the equivalent of 30 minutes of static cycling per week 5. Judged by the investigator to have high levels of functional limitations which will prevent the participant from getting on and off the exercise bike

Design outcomes

Primary

MeasureTime frame
Self-reported function measured using the function, daily living component from the Hip Disability and Osteoarthritis Outcome Scale (HOOS) at baseline and at 10 weeks

Secondary

MeasureTime frame
1. Hip Disability and Osteoarthritis Outcome Score (HOOS) function measured as a score out of 100 after completion of the HOOS Questionnaire at baseline and 24 weeks (score at 10 weeks is primary outcome) 2. HOOS pain score after completion of the HOOS Questionnaire at baseline, 10 weeks and 24 weeks 3. HOOS symptoms score after completion of the HOOS Questionnaire at baseline, 10 weeks and 24 weeks 4. HOOS stiffness score after completion of the HOOS Questionnaire at baseline, 10 weeks and 24 weeks 5. HOOS sports and recreational activities score after completion of the HOOS Questionnaire at baseline, 10 weeks and 24 weeks 6. HOOS Quality of Life score after completion of the HOOS Questionnaire at baseline, 10 weeks and 24 weeks 7. Function assessed by 30-second chair stand test at baseline and 10 weeks 8. Function assessed by stair climb test at baseline and 10 weeks 9. Function assessed by 40-metre walk test at baseline and 10 weeks 10. Patient activation measured by responses to PAM Questionnaire at baseline, 10 weeks and 24 weeks 11. BMI, body composition, blood pressure and resting heart rate measured at baseline and 10 weeks 12. Analgesia use measured by Resource Use Questionnaire at baseline, 10 weeks and 24 weeks 13. Patient-perceived general health measured using EQ-5D Visual Analogue Score (VAS) at baseline, 10 weeks and 24 weeks 14. Patient-perceived quality of life measured by EQ-5D-5L Questionnaire at baseline, 10 weeks and 24 weeks, used to derive Quality Adjusted Life Years (QALYs) 15. Self-reported resource use measured by responses to the Resource Use Questionnaire at baseline, 10 weeks and 24 weeks

Countries

England, United Kingdom

Contacts

Public ContactTikki Immins
t.immins@nhs.net+44 (0)1202 961941

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026