To investigate the clinical effectiveness of an exercise rehabilitation programme with integrated support for adherence compared to exercise rehabilitation only.
Using an intervention mapping approach, we developed an exercise adherence intervention underpinned theoretically by the COM-B behaviour change model. 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. Additionally, the intervention arm received an integrated exercise adherence intervention that used ≥ 3 behaviour change techniques from a toolkit of 9 techniques to support exercise behaviour.
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).
126 Participants were recruited aged a mean 72.7 (SD 8.0) years with a mean 2.3 (SD 1.7) VFF. 83 % (n=104) were female, 22 (17%) male, 117 (93%) reported back pain in past 2 weeks and 58 (46%) had fallen in previous year. Intervention participants received a median 5, IQR 3-6 physiotherapy sessions, control participants a median 5, IQR 2-6 sessions.
At 12-months, 112 completed the final outcome assessments. 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 OPTIN RCT found integrated, additional support for exercise behaviour within a programme of physiotherapy exercise 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.
The adherence toolkit was well received by treating physiotherapists with good fidelity and reported clinical utility. Incorporating in clinical practice may improve adherence to home exercise and improve outcomes.
exercise adherence
osteoporosis
