Background
Primary objective:
Secondary objectives
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To compare the effect of an exercise and fall prevention self-management program versus usual care on balance and mobility, falls risk, physical activity, walking aid use, frailty, pain, nutrition, falls efficacy, mood, positive and negative affect, quality of life, assistance from others, hospital readmission, and health-system and community-service contact in older people with a recent fall-related lower limb or pelvic fracture.
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To establish the cost-effectiveness and cost-utility of the intervention approach, compared with that of usual care, from the perspective of the health and community care funder.
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To describe the safety and tolerability of the program.
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To determine features associated with uptake of the intervention.
Methods / design
Design
Participants
Randomisation and blinding
Intervention
Home exercise program
Fall prevention education
Control group
Data collection
Outcome measures
Primary outcome measures
Secondary outcome measures
Domain | Assessment | Description |
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Balance and mobility | Coordinated stability test [53] | Measures ability to adjust body position in a controlled manner when near the limit of the base of support. |
Maximal balance range test [53] | Measures the maximum distance participants can lean backward and forward. | |
Step Test [54] | Dynamic single limb stance is assessed by counting the number of times the participant is able to step one foot on, then off, a 7.5 cm block as quickly as possible in 15 seconds. | |
Short Physical Performance Battery (SPPB), individual components | The SPPB components are the ability to stand (for 10 sec) with the feet together in the side-by-side, semi-tandem, and tandem positions; time taken to walk four metres; and time to rise from a chair and return to the seated position five times. | |
Choice stepping reaction time [55] | Time to complete a standardised stepping routine onto four white squares on a portable mat, while standing. | |
Falls and fall risk | Fallers | Proportion of fallers (people having one or more falls) over the 12-month follow-up period. |
Injurious falls and fractures | Number of falls requiring medical attention and fractures over the 12-month follow-up period. | |
Includes five measures of physiological functioning (knee extension strength, postural sway, reaction time, lower limb proprioception and visual contrast sensitivity). | ||
Physical activity | Incidental and Planned Exercise Questionnaire [57] | Level of physical activity relating to both basic and more demanding activities is assessed with a 10-item questionnaire. |
Walking aid use | Use of walking aid | The use and type of walking aid is recorded both indoors and outdoors. |
Frailty | 6-point scale based on the Fried criteria [58] | Frailty is measured using five criteria: unexplained weight loss, grip strength, exhaustion, walking speed, activity level. |
Pain | 6-point numeric rating scale | The participant selects a whole number that best reflects the intensity of their pain. |
Nutritional status | Mini Nutritional Assessment [34] | Screens for, and assesses, malnutrition in older people. |
Body mass index | Bodyweight in kilograms divided by height in metres squared. | |
Fall-related self-efficacy | Questions about self-rated fear of falling and balance | Participants are asked to rate their perceived balance and their fear of falling on 5-point ordinal scales |
Short version of the Falls Efficacy Scale-International [59] | Level of concern about falling during a range of activities is rated on a 4-point scale. | |
Mood | Five-item version of the Geriatric Depression Scale [60] | Screens mood in older people. The five-item Geriatric Depression Scale is comparable with the 15-item version in terms of psychometric properties. |
Positive and negative affect | Positive and Negative Affect Scale [61] | Two 10-item scales that measure positive and negative affect. |
Health-related quality of life | European Quality of Life-5 dimensions (EQ-5D-5 L) [36] | A standardised measure of health status that provides utility weights to allow calculation of quality adjusted life years (QALYs) for use in the economic evaluation [62]. |
Short Form 12-item Survey (SF-12) Version 2 [63] | A 12-item questionnaire that measures functional health and well-being. | |
Assistance from others | Three questions about assistance received | Establishes the presence of, and reason for, assistance from agencies, family or friends. |
Hospital re-admission | Number of hospital readmissions and days in hospital during the follow-up period | Ascertained via the same calendars used for falls follow-up over the first 12 months of the study, follow-up phone calls for missing calendars and contact with carers if contact is lost with the participant. At 2 and 4 years after randomisation, data linkage will be undertaken via the New South Wales Centre for Health Record Linkage (NSW CHeReL) to seek information regarding mortality and hospital admissions. |
Health-system and community-service contact | Number of contacts with health and community services | Collected on a monthly basis along with the falls calendars. Inpatient hospital and emergency department contact will be assessed using data linkage via the NSW CHeReL. Data will also be used in economic analyses. |
The stage of motivational readiness for change | Physical Activity Stages of Change Questionnaire [48] | The 4-item questionnaire measures the stage of readiness to change and self-efficacy to exercise. |