Abstract
The aim of this trial was to evaluate the clinical effectiveness and cost-effectiveness of a home-based exercise program delivered four months following hip-fracture surgery. In the two-armed randomized, single blinded clinical trial we included persons who lived in the catchment area, were 70 years or older, and community-dwelling at time of the fracture. We excluded persons who were unable to walk ten meters prior to the fracture, and those who were bedridden or had medical contraindications for exercise at baseline (ie. four months after the fracture). All participants underwent routine treatment and rehabilitation. The intervention group received additional 20 sessions (10 weeks) structured, home exercise targeting gait and balance, delivered by physiotherapists in primary health care. Gait speed was the primary outcome. Secondary outcomes included physical activity, gait characteristics, cognitive function, activities of daily living, health-related quality of life, and health care costs extracted from hospital and municipality records. In total, 223 participants were included. Four months post surgery 143 were randomized for the exercise trial (70% women, mean age 83.4 (SD 6.1) years, mean gait speed 0.6 (SD 0.2) m/sec). Estimated between group difference in gait speed was 0.09 m/sec (95% CI: 0.04 to 0.14, p<0.001) at posttest and 0.07 m/sec (95% CI: 0.02 to 0.12, p = 0.009) 12 months post surgery. The mean between-group QALY difference was -0.009 (95% CI: -0.061 to 0.038). The mean between-group total cost difference was +242.9 EUR (95% CI: -8397 to 8584). Our findings suggest that gait recovery after hip fracture can be improved by introducing a home-based balance and gait exercise program four months post surgery, without increasing total health care costs. Future research should focus on how to implement gait and balance exercise in comprehensive interventions that increase adherence among the most vulnerable persons and have an effect on daily life activities and patient-centred outcomes.Trial registration: ClinicalTrials.gov NCT01379456.
Highlights
Hip fracture in old age represents a dramatic change in life situation [1, 2] and triggers increased use of health and care services [3, 4]
Participants who were included at T0 but not randomized at T1, scored lower on measures of activities of daily living (ADL) and cognitive function (S1 Table)
We found that 30% of the participants randomised to the exercise intervention never started or completed the intervention mainly due to decline in health status, indicating a need for alternative approaches to target the most vulnerable individuals [7]
Summary
Hip fracture in old age represents a dramatic change in life situation [1, 2] and triggers increased use of health and care services [3, 4]. Gait speed is regarded as a vital sign and a robust indicator of health and function in older adults [12] and is recommended to be used as an outcome in clinical trials including frail populations [13]. Older people who have sustained a hip fracture report mobility to be the most valued outcome of rehabilitation [15]. Systematic reviews conclude that extended rehabilitation following hip fracture, delivered outside a hospital setting and after formal rehabilitation is completed, has a beneficial effect on gait and mobility [17, 18]. Cognitive impairment [23], depressive symptoms [24, 25], and limitations in outdoor mobility [26] are common among older people with hip-fractures and may be a barrier for participation in clinical trials. At present, increased costs are often an argument used against supervised, homebased exercise [27], the cost-effectiveness of such interventions has been scarcely evaluated
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