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Table 3 CHAIN Intervention description following the TIDIER checklist [24]

From: CycLing and EducATion (CLEAT): protocol for a single centre randomised controlled trial of a cycling and education intervention versus standard physiotherapy care for the treatment of hip osteoarthritis

1. Name

CHAIN: Cycling against Hip Pain

2. Why

The rationale for the CHAIN intervention is based on the need to develop an effective model of care locally to deliver the nonsurgical interventions recommended by NICE (2014). It was conceived by a consultant orthopaedic surgeon and a physiotherapist in response to discussions locally with primary care providers suggesting that ‘standard care’ for patients reporting hip stiffness to their GP can be varied and inconsistent, ranging from general advice, advice on analgesia and/or physiotherapy and self -management. It was further developed through discussion with local orthopaedic teams and physiotherapists and in partnership with the local general hospital, the county commissioning group, general practitioner localities, the county sports partnership, the borough council and the university. The aim of the programme is to reduce pain and encourage mobility through a programme of education and static cycling sessions to equip participants with the confidence to self-manage their condition.

3. What: Materials

CHAIN videos which will be shown to participants by the facilitator during the CHAIN sessions and can be accessed by the participants in their own time after the sessions. The cycling sessions were developed by senior physiotherapist and fitness instructors from the leisure centre to ensure that the sessions are the same in each cohort. Figure 2 shows a breakdown of the cycling and education content week-by-week.

4. What: Procedures

Screening: Prior to enrolment, participants are reviewed under the GP referral for exercise to ensure their suitability to attend the sessions.

Education: For the first thirty minutes, participants will take part in an education class, facilitated by a qualified physiotherapist. The education sessions will be standardised through video recordings developed by the study team and based upon NICE guidelines, aiming to promote the effective on-going self-management of hip pain. The education classes also aim to motivate participants to exercise, reassure them that it is safe to do so, and facilitate positive lifestyle/activity change. At the end of the class, the physiotherapist will encourage group discussion so that participants can share their questions and experiences.

Cycling: The education session will be followed by a 30 min indoor static cycling class (35 and 40 min for the last two sessions respectively), facilitated by a gym instructor trained in leading indoor cycling classes. On the first week, participants will be shown how to set up their bike. The intensity of the exercise class will increase on a weekly basis and will be clearly defined to ensure each cohort will be given the same programme. Each session will finish with a cool-down period which will include relevant stretches. Participants will be encouraged to work at a level that they are comfortable with and will be encouraged to increase their intensity progressively over the eight sessions.

Between sessions: After completion of the class, the participants will receive a video of the education class and of the static cycling session, via text or email, to encourage exercise and compliance to behaviour change advice at home. A home exercise programme comprising of various ankle, knee and hip stretches will also be provided and participants will be encouraged to stretch regularly. Cycling between sessions will be encouraged but will not be mandatory. To encourage participants to increase their exercise activities, an activity diary will be provided so that progress at home can be recorded and monitored for the duration of the intervention, including planned pauses in the delivery of the intervention. Plans for lifestyle changes and on-going participation in community-based activities will also be discussed.

5. Who provided

Physiotherapists: Local NHS senior physiotherapists will facilitate group discussions during each weekly education session. As trained by the study team, they will encourage participants to share experiences and ask questions related to that week’s topic or the management of their hip pain in general. The physiotherapists will also ensure adherence to the intervention by reminding participants to complete their activity diaries in between sessions.

Fitness Instructor: a qualified and experienced fitness instructor from the local leisure centre will deliver the cycling session each week. The fitness instructors have experience of leading cycling sessions with mixed ability groups and have helped to design the content of each weeks’ session alongside the study team.

6. How

The intervention will be delivered face-to-face in a group setting. After each weeks’ session, participants will be sent a link (via email or text message) to that weeks’ education and cycling session as well as the home exercise programme so that they can be reviewed in between sessions in participants’ own time. A short report detailing changes in assessment scores will be sent to participants following treatment.

7. Where

Intervention will be delivered at a suitable local leisure centre, equipped with space to deliver the education session and an appropriately equipped cycling studio that has space for up to 15 participants to take part in a single cycling session

8. When and how much

The CHAIN intervention is an 8-weeks cycling and education programme where participants will attend a one-hour education and exercise session on a weekly basis at a local leisure centre. It is not necessary for the intervention to be delivered in consecutive weeks and a short pause in delivery of the programme will be possible in the case of local facilities having to close, i.e., due to public holidays or other situations out of the study team’s control. However, if a participant misses a planned course, there will not be an opportunity to provide a catch-up session and the participant will be marked as absent from the session. Dosage received for each participant will be calculated based on sessions attended and length of those cycling sessions along with the recommended cycling intensity.

9. Tailoring

Static cycling is an accessible form of exercise which can be tailored to all levels of ability and fitness within a group setting.

10. Modifications

N/A

11. How well: Planned

Adherence will be assessed by registering the attendance of each participant at each session. Activity diaries will be given to participants to record any activities undertaken outside of the intervention. Participants will be reminded by the senior physiotherapist each week of the importance of the completion of these diaries including recording of the how frequently participants complete the Home Exercise Programme (HEP). The activity diaries will be collected at the Visit 4 and the data analysed, including adherence to the HEP

12. How well: Actual

N/A