OsteoPorosis Tailored exercise adherence INtervention (Opt-In)
Research type
Research Study
Full title
Physiotherapy exercise rehabilitation with tailored exercise adherence support for people with osteoporosis and vertebral fractures: A randomised controlled trial. OsteoPorosis Tailored exercise adherence INtervention (OPTIN):
IRAS ID
287716
Contact name
Karen Barker
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
ISRCTN Number
ISRCTN14465704
Duration of Study in the UK
2 years, 3 months, days
Research summary
Summary of Research
Background: Osteoporosis is a condition where bones lose strength and break easily. People with osteoporosis need to keep active and exercise regularly to help manage their condition. Exercise can help to maintain an upright posture, maintain strength and balance, to continue everyday activities and prevent falls and fractures. Unfortunately, research shows sticking to exercise programmes is difficult. Techniques to encourage exercise habits may be helpful.
Aim: This study will test if adding a personalised programme of support techniques to encourage exercise adherence to a course of exercise based physiotherapy is of more benefit to patients compared to exercise based physiotherapy alone.
Methods: Patients who have osteoporosis and a spinal fracture will be invited to take part. The study will compare two groups. One group will be offered exercise based physiotherapy (Usual Care). The other group will be offered this plus adherence to exercise support techniques (Intervention group). A computer programme will place patients at random into either group (similar to the toss of a coin).
Patients in the intervention group will be asked about their preferences, motivators and barriers related to exercise. The physiotherapist will prescribe exercises and at least 2 exercise adherence support techniques to suit the individual, selecting from a toolkit of tested support techniques.
The study will be completed in four NHS physiotherapy departments. It will test whether enhancing physiotherapy exercise rehabilitation with adherence support benefits patient wellbeing, physical function and exercise participation. Patients will be asked to complete five brief questionnaires and measures of balance, back strength, spinal shape and walking before and at 4, 8 and 12 months after treatment.
12-15 patients who undertake the physiotherapy plus exercise support treatment will be invited to participate in an interview about their experiences of exercise adherence.
8-10 physiotherapists delivering the intervention will be invited to a focus group.Summary of Results
The OPTIN trial sought to compare physiotherapy exercise rehabilitation with adherence support with physiotherapy exercise rehabilitation alone in terms of effects on physical function, quality of life, and fear of falling in patients with symptomatic vertebral fragility fractures.
It also sought to explore if the intervention was acceptable to patients and whether it was economic.
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 techniques, selecting from an intervention toolkit of nine techniques to support exercise behaviour. Ninety minutes of additional physiotherapy time are provided to deliver the intervention, integrated within the initial assessment and across six follow-up visits.We evaluated this with a two-arm, individually randomised controlled trial (RCT) with blinded outcome assessments at baseline, 4, 8 and 12 months. Eligible participants were 55 years or older with ≥1 Vertebral Fragility Fracture (VFF) associated with osteoporosis and back pain. Both arms received progressive exercise rehabilitation including strength, posture, balance, and weight-bearing exercises prescribed by a physiotherapist.
The primary outcome was lower extremity function, dynamic balance and fall risk, measured via the Timed-Up and Go (TUG) at 12-months.
Secondary outcomes included quality of life (QUALEFFO-41), Thoracic kyphosis, standing balance (Functional reach: FR), muscle strength (timed loaded standing: TLS) and walking exercise capacity (6-minute walk: 6MW).We recruited 126 participants with final outcome data for 112 participants (sample size calculations required 116 participants allowing for 10% withdrawals).
Clinically relevant, statistically significant gains were seen favouring the intervention group in the TUG intervention mean 10.1 (SE 0.38) seconds versus mean12.9s, effect size: 2.1s, 95% CI: -3.1 to -1.0s, p=0.000) and 6MW intervention mean 354.6 (SE 6.6) metres versus control 325.7(SE 6.9) m, effect size 24.5m, 95% CI: 5.7 to 43.4m, p=0.011).
Differences in QoL, FR, Thoracic Kyphosis and TLS between arms at 12-months were not significant.There were 23 adverse events (8 intervention, 15 control), none related to physiotherapy exercise rehabilitation.
The health economic evaluation found at 12-month follow-up, the intervention group outperformed the usual care group in terms of mean utility scores (0.740 vs. 0.716), indicating that the intervention may have contributed to more sustained improvements in HRQoL. Participants in the intervention group incurred a higher mean cost of £578.23 compared to £500.85 for the usual care group. This difference of £77.38 reflects the more intensive nature of the intervention, which involved longer physiotherapy sessions and additional contact time focused on adherence support.
In our embedded qualitative study, we interviewed 12 participants (10 female, 83%) from the intervention group of four different sites. We interviewed each participant at three timepoints: within 2 weeks after their initial session, at 4 months and at 12 months.
These interviews found the importance of an individualised approach to exercise and adapting exercises into everyday life, the influence of emotions on the physical state and how this may impact exercise adherence behaviour and a transition from adhering to exercise to incorporating activity in everyday lifestyle changes.In the future we intend to further explore the OPTIN toolkit to assess if there may be benefits in utilising it in other long term musculoskeletal conditions where exercise forms a key part of management strategies.
REC name
West of Scotland REC 4
REC reference
21/WS/0071
Date of REC Opinion
10 Jun 2021
REC opinion
Favourable Opinion