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 sites221 target enrollmentOctober 21, 2019

Overview

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

Registry

who.int

Start Date

October 21, 2019

End Date

March 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospitals Dorset NHS Foundation Trust

•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

•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