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.