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View larger version:In a new windowDownload as PowerPoint SlideFlow chart of trial participants. *Requested to discontinue the exercise programme; does not include some participants who were not exercising in the final month (LiFE, n=10; structured, n=18; control, n=19)We recruited and randomised 317 people from February 2006 to December 2007. We saw no important differences between intervention or control groups in baseline measures (table 1?). The fall data outcomes were missing for 31 (10%) randomised participants. For the secondary measures, 76 (24%) participants were not available at the final 12 month assessment. Since the frequency and causes of missed assessments were similar between groups (fig 1), we did a “complete case” intention to treat analysis.29View this table:View PopupView InlineTable 1 Demographic and health status of trial participants at baseline. Data are no (%) of participants unless stated otherwiseFalls outcomeAfter 12 months of follow-up, we recorded 172 falls in the LiFE group, 193 in the structured exercise group, and 224 falls in the control group. The LiFE, structure exercise, and control groups had 21, 24, and 26 people who fell once, and 39, 41, and 45 who fell at least twice, respectively. Median length of follow-up for all participants was 365 days (range 2-468, interquartile range 357-372). The overall incidence of falls in the LiFE programme was 1.66 per person years, compared with 1.90 in the structured programme and 2.28 in the control group. We recorded a clinically important reduction of 31% in the rate of falls for participants in the LiFE programme compared with the control programme (incidence rate ratio 0.69 (95% confidence interval 0.48 to 0.99), n=212). We did not see a significant reduction in the fall rate for participants in the structured programme compared with the control programme (0.81 (0.56 to 1.17), n=210).Tables 2 to 5? ? ? ? present the secondary measures summarising the major outcomes. If the general linear modelling analysis was significant for all three programmes, we then confirmed which of the interventions was effective through pairwise analysis. We also presented Cohen effect sizes to provide an indication of clinical effectiveness for easier interpretation. View this table:View PopupView InlineTable 2 Balance outcomesView this table:View PopupView InlineTable 3 Strength outcomes View this table:View PopupView InlineTable 4 Outcomes for secondary measures of function View this table:View PopupView InlineTable 5 Outcomes for other secondary measures Balance and strengthTables 2 and 3 summarise the findings for balance and strength outcomes over the 12 month study follow-up. LiFE participants significantly improved compared with controls, with moderate to large effect sizes for the two balance hierarchy scales. The structured programme showed small and significant effects for the five level scale (table 2). Dynamic balance measured by the timed tandem walk showed a significant and moderate effect for both the LiFE and structured programme compared with the control programme. Ankle strength significantly improved in the LiFE programme compared with controls (table 3). Knee and hip strength changes were not significant for either programme because the control group also made some intermittent gains.Functional outcomesTable 4 summarises secondary findings for functional measures. Activities of daily living using the NHANES measure was significantly improved for the LiFE participants compared with controls, with a moderate effect size. The Late Life Function Index showed large and significant effects for LiFE and a moderate and significant effect for the structured programme. The measure of participation, the Late Life Disability Index (frequency), was significantly improved for the LiFE group, with a moderate effect size. Both LiFE and structured programmes made significant gains in balance confidence, with small to moderate effect sizes (table 4). Physical activity, measured by the Physical Activity Scale for the Elderly, showed small but significant gains for the LiFE programme.Other secondary outcomesThe Paffenbarger scales showed increased energy expenditure by both the LiFE and structured programmes, with moderate and small effects, respectively (table 5). The life space index showed no change in temporal range of activity spaces. Health status, measured by the itemised questions of the EQ-5D, did not differ significantly between groups, however, when participants were asked to rate their health status using the EQ-VAS scale, LiFE participants reported a significantly better health status at 12 months. We saw no significant difference in fat free mass. Body mass index showed that the controls increased their body mass index, which was significant compared with the structured group.Adverse eventsTwo patients reported severe adverse effects that they attributed to the exercise programme. One participant in the structured programme had a groin strain and surgery for an inguinal hernia and ceased the programme; a LiFE participant was diagnosed with a pelvic stress fracture and attributed this to increased walking and stair climbing, but continued on the programme.AdherenceTable 6? shows the mean proportion of adherence to each exercise programme over the first six months; the structured programmed showed a significant group effect (P=0.01) with the lowest adherence. Retrospective analysis confirmed that the adherence to the structured programme was significantly lower than either the LiFE programme (mean difference 0.12, t=2.82, P<0.01) or the control programme (0.13, 2.66, P<0.01). Although each programme had similar numbers of participants who withdrew at six months of follow-up, the pattern for poor adherence (that is, =25%) varied between the three programmes (table 7?).View this table:View PopupView InlineTable 6 Analysis of variance for adherence to exercise programmes over first six monthsView this table:View PopupView InlineTable 7 Exercise status over six months. Data are no (%) of participantsThere were 68 (64%) participants exercising at 12 months in the LiFE programme (seven (6.5%) did not return records but provided self reports), 56 (53%, including 12 (11.4%) self reports) in the structured programme, and 56 (53%, including seven (6.7%) self reports) in the control programme. Of 61 LiFE participants who completed exercise records, the mean number of days in which the exercises were done per week in the final month was 3.89 (standard deviation 2.13; interquartile range 2.24-6.00), of a maximum seven days. Of 44 participants in the structured programme who returned exercise records and were exercising at 12 months, 43 (98%) were still doing the balance exercises, 26 (59%) were doing strength exercises with rod weights (weight range 1-6.5 kg, median 5 kg), and four (9%) were doing isometric strength exercises.DiscussionLiFE is a tailored programme of embedded balance and strength activities, taught over five home visits with two booster visits. It was designed to reduce fall risk and resulted in a clinically important 31% reduction in the rate of falls compared with the control programme, which involved gentle sham exercise. A 30% reduction in falls is similar to most interventions currently recommended for fall prevention in clinical guidelines. The structured lower limb strength and balance exercises, taught over a similar time frame and prescribed three times a week, did not show significant results, with a 19% reduction in the rate of falls compared with the controls. Furthermore, the LiFE programme was superior in terms of function and participation, providing support that this programme mediates both fall risk and frailty. LiFE programme participants improved in both static and dynamic balance, showing moderate effect sizes with the strongest effect observed into the high end static balance measure. The structured programme showed a small effect on static balance and a moderate effect on dynamic balance. The importance of balance, as the most important exercise component in mediating fall risk, was highlighted in a systematic review of 44 exercise trials,4 which examined trials in terms of both fall outcome and exercise intensity. Training in control of postural sway seems to affect the vestibular system by improving individual capacity to regain and control balance.30 The functional activities in the LiFE programme also translated into moderate changes in ankle strength. Ankle strength is understood to be a prime factor for an effective strategy for the ankle when a pertubation occurs, and therefore is protective of falls.31 While LiFE showed steady improvements, all programmes made variable gains for knee and hip strength.Two other exercise programmes to prevent falls have reported physical activity outcomes using the Physical Activity Scale for the Elderly.32 33 Both reported less deterioration in controls than in the intervention group, whereas we reported an increase in physical activity in both the structured and control programmes, with a small significant effect for the LiFE programme. The strong response from the Paffenbarger measure of energy expenditure for LiFE could be linked to its use of increased physical activity, in particular stair climbing, for many participants. The LiFE programme also had better outcomes than the structured programme on the functional and daily activity measures, with significant and moderate to large effect sizes for LiFE participants. This effect suggests that the LiFE programme could improve functional capacity in frail older people. There might be value in testing whether the LiFE programme and philosophy could be introduced at a younger and earlier stage, to mediate functional decline whether or not a person has experienced a fall.The LiFE programme is unique and novel; no other interventions have used a tailored approach to embedded exercise with functional activity. We did find three other programmes offering either structured exercise that included functional movement or specific balance tasks that showed positive outcomes. These programmes perhaps lend some support to the effects of the integration component of the LiFE programme.34 35 36Dual tasking LiFE activities include a range of activities and can upgrade balance and strength challenges in small but incremental ways. For some people, these exercises have included ironing while standing on one leg, talking on the phone while heel standing and moving to limits of stability, carrying a tray or drink in a cup while tandem walking, squatting in the supermarket to select an item from a lower shelf rather than bending, and carrying the groceries from the car to the porch while walking sideways. Emerging evidence suggests that a person’s capacity for dual tasking can predict their risk of falls, particularly capacity for tasks that involve gait variability and attention demanding tasks,37 with increased risk for repeat fallers.38. Furthermore, training in specific dual task activities to challenge balance in older people, undertaken in clinics, has been shown to improve gait stride and variability, and dynamic and static balance. However, these clinic interventions have not been shown to be transferable to novel situations.30Tailored and embedded activity that aligns with functional conditions and everyday tasks could enhance integration of skills such as task co-ordination, postural control, and spatial processing. Along with physiological changes, these activities could lead to translation of protective skills in other situations. Liu-Ambrose and colleagues39 presented a central benefit model of exercise for fall prevention, arguing that the contribution of attention, dual tasking, planning, and other executive functioning might be just as important as physiological outcomes. The LiFE approach shows that a sole exercise intervention designed to prevent falls can have a clinically important effect on function at the level of participation engagement.40Adherence was significantly better in the LiFE programme and control group than in the structured exercise programme, which was evident in the detailed frequency analysis over the first six months. All three programmes maintained a good adherence at 12 months, although adherence to the LiFE programme remained superior. All programmes exceeded the 42% adherence reported in the New Zealand Otago trial, which tested a successful exercise programme that was structured and home based.32 The measures of intensity varied for each programme, making an exact comparison difficult. The structured programme in our study had less follow through with the strength component, although our results were still near to the Otago result. In our study, therapists commented that many older participants struggled with the cumbersome nature of the weight cuffs, and we recommend investment in better designs. Many participants in the control group made comments; some liked the gentle exercise and others regarded them as “too easy’ and not meeting their needs.The lower performance of the structured programme in terms of a falls outcome might also be due to the range of challenge activities and upgrades needing to be enhanced. In addition, recruitment of participants with recurrent or injurious falls resulted in a higher risk group with multiple problems in our study than in the New Zealand Otago trial.32LimitationsThe control group received less contact time than both interventions, which could have caused a bias, but we saw no difference in the return rates of fall surveillance diaries, so this is unlikely. Also, adherence to the control and LiFE programmes was similar over the first six months, which spanned the interventionists’ follow-up phase. The falls outcome for the LiFE programme was significantly different from controls; however, the higher confidence interval was close to 1, indicating some caution with interpretation of these results, and further research with the LiFE intervention should aim to replicate our findings. The strong outcomes of the secondary measures point to clear mediators of benefit and confirm there was a positive fall outcome. The control group had an intervention that could have diluted the effect of the outcomes. Since the control exercises were gentle, flexible, mostly non-weightbearing, and not upgraded by the therapists, their effect on fall reduction or balance would have been marginal,41 42 43 although we did observe some minimal strength improvements. Our study had a slightly lower sample size than preferred, which could have led to a type II error. If we had greater power to detect a difference, the confidence interval would probably have been narrower. Furthermore, the fall rate was higher than expected, which could also reduce the required sample size. Despite these limitations, we did find statistical significance. The pilot study, matched against a control programme of no intervention, showed a large reduction of falls, adding further support to our findings. A meta-analysis combining the pilot study9 and our current findings gave an incidence rate ratio of 0.63 (95% confidence interval 0.45 to 0.90), using Comprehensive Meta-Analysis software (version 2).ConclusionThe LiFE programme provides an additional choice to traditional exercise and another fall prevention programme that could work for some people. Functional based exercise should be a focus for protection from falling and for improving and maintaining functional capacity for older people at risk. The programme has many positive outcomes: increased energy to do more tasks, improved function during activities, and enhanced participation in daily life. In a modern world that increasingly relies on increased automation and doing less, the LiFE programme provides a beneficial environment that offers some stressors and complexity. Furthermore, it challenges allied health professionals to expand their focus when working with older people to find opportunities to incorporate balance and strength training into daily life.What is already known on this topicBalance and strength training is known to reduce falls in older adults However, less than 10% of older people routinely engage in strength training and is probably lower for activities that challenge balanceWhat this study addsThe Lifestyle integrated Functional Exercise (LiFE) programme provides an alternative to traditional exercise for older people to reduce falls, to improve function in doing activities and to enhance participation in daily lifeThe LiFE programme demonstrates that having an environment that offers some stressors and complexity is beneficialNotesCite this as: BMJ 2012;345:e4547FootnotesWe thank Jo Munro for her contribution to the development of the LiFE programme, Elvina Weissel for her support, the Department of Veteran’s Affairs for assistance with recruitment, Melissa Abela for compiling the six month adherence data, and Augustus Yip for preparing the body composition estimates. Contributors: LC (principal investigator) designed the study and protocol, led the development of the LiFE programme, wrote the grant application, analysed data, interpreted results, and wrote the paper. LC is guarantor. MAFS contributed to the study design, grant application, and development of the LiFE programme; provided the structured and control programmes; and contributed to the interpretation of study results and writing of the paper. AB contributed to the study design, grant application, interpretation of results, and writing of the paper. RGC contributed to the study design, grant application, interpretation of study results, and writing of the paper. KM recruited participants, conducted assessments, and managed and cleaned the data. PO conducted interventions, managed the intervention team, and collected adherence data. DB provided advice on statistical analysis, interpretation of results, and writing of the paper.Funding: The trial was funded by a project grant from the National Health and Medical Research Council. Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: support from the National Health and Medical Research Council; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.Ethical approval: This study was approved by the University of Sydney human ethics committee. Data sharing: Requests for data sharing should be directed to LC and would be considered as required.Study protocol available from corresponding author.This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.References?Bleijlevens MHC, Diederiks JPM, Hendriks MRC, van Haastregt JCM, Crebolder HFJM, van Eijk JTM. Relationship between location and activity in injurious falls: an exploratory study. BMC Geriatrics2010;10:40.OpenUrlCrossRefMedline?Watson W, Clapperton A, Mitchell RT. The incidence and cost of falls injury among older people in New South Wales 2006/07. NSW Department of Health, 2010.?Irwin M, Hayen A, Finch C. 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