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)

niversity Hospitals Dorset NHS Foundation Trust0 个研究点目标入组 221 人开始时间: 2019年10月21日最近更新: 2024年4月15日

适应症

试验速览

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37138278/ (added 04/05/2023)

•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

•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

发起方

niversity Hospitals Dorset NHS Foundation Trust