Exercise rehabilitation with tailored support for exercise adherence for people with vertebral fragility fractures is more effective than standard rehabilitation: the OPTIN randomised controlled trial.

UNLABELLED: This study assessed the effect of adding an adherence support intervention to exercises for vertebral fragility fractures. The findings showed the intervention group demonstrated significantly better outcomes for Timed-up and Go test and 6 min walk test. Additional support for exercise behaviour provided greater benefits than exercise alone. PURPOSE: To investigate whether an exercise rehabilitation programme with integrated adherence support would be more effective than exercise alone. METHODS: Two-arm, individually randomised controlled trial with concealed allocation, assessor blinding and intention to treat analysis. PARTICIPANTS: One hundred twenty-six people over 55 years with at least one vertebral fragility fracture and back pain; 63 per group. Both arms received progressive exercise rehabilitation including strength, posture and balance exercises. Additionally, the intervention arm received an integrated exercise adherence intervention that utilised a motivational interviewing approach, goal setting and ≥ 3 behaviour change techniques to support exercise behaviour. The primary outcome was 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-min walk: 6MW). RESULTS: At 12 months, 57 intervention and 55 control participants were analysed. Clinically relevant, statistically significant gains were seen favouring the intervention group in TUG mean 10.1 (SE 0.38) seconds versus mean 12.9 s; effect size, 2.1 s; 95% CI, - 3.1 to - 1.0 s; p = 0.000) and 6MW mean 354.6 (SE 6.6) m versus control 325.7 (SE 6.9) m, effect size 24.5 m, 95% CI, 5.7 to 43.4 m, p = 0.011). There were no significant differences in the other outcome measures and no related adverse events. CONCLUSIONS: This RCT found integrated, additional support for exercise behaviour within a programme of physiotherapy rehabilitation for people with VFF provided greater benefits to lower extremity function, balance and walking at 12 months as measured by the TUG and 6MW tests.