Development and implementation of a physiotherapy exercise intervention with tailored support for exercise adherence for people with vertebral fragility fractures (OPTIN trial).

Objectives: The OsteoPorosis Tailored exercise adherence INtervention (OPTIN) trial is a two-arm, multi-centre randomised controlled trial. It compares the effectiveness of physiotherapy exercise rehabilitation with integrated support for exercise adherence, to physiotherapy exercise rehabilitation alone, for people with vertebral fragility fracture (VFF) and back pain. This paper describes the development of the physiotherapist-led adherence enhanced intervention.

Methods: We used an intervention mapping approach and followed Medical Research Council guidelines for developing complex interventions. We co-created the intervention involving expert clinicians, service managers, researchers, and adults with long-term musculoskeletal conditions, including osteoporosis. We identified a theoretical framework, reviewed the evidence, used a feasibility study, and considered clinical practice and deliverability within UK National Health Service (NHS) outpatient physiotherapy secondary care. Through a collaborative workshop, we refined the intervention, involved patients again and re-tested the intervention. Finally, we manualised the intervention, produced patient and physiotherapist materials and trained physiotherapists for delivery.

Results: The OPTIN intervention uses a motivational interviewing approach and captures information about patient goals, barriers, and facilitators to exercise. Physiotherapists assess exercise capability, opportunities and motivation and utilise at least three behaviour change approaches, selecting from an intervention toolkit of nine approaches to support exercise behaviour. Ninety minutes of additional physiotherapy are provided to deliver the intervention, integrated within the assessment and six follow-up visits.

Conclusions: A theory-informed intervention to support exercise adherence was developed and delivered by physiotherapists trained in the intervention to older adults with VFF and back pain in the intervention arm (n = 63) of the OPTIN trial.

Trial Registration Number: ISRCTN 14465704. CONTRIBUTION OF PAPER.