Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial ========================================================================================================================================================= * Lindy Clemson * Maria A Fiatarone Singh * Anita Bundy * Robert G Cumming * Kate Manollaras * Patricia O’Loughlin * Deborah Black ## Abstract **Objectives** To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older, high risk people living at home. **Design** Three arm, randomised parallel trial; assessments at baseline and after six and 12 months. Randomisation done by computer generated random blocks, stratified by sex and fall history and concealed by an independent secure website. **Setting** Residents in metropolitan Sydney, Australia. **Participants** Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months, recruited from Veteran’s Affairs databases and general practice databases. Exclusion criteria were moderate to severe cognitive problems, inability to ambulate independently, neurological conditions that severely influenced gait and mobility, resident in a nursing home or hostel, or any unstable or terminal illness that would affect ability to do exercises. **Interventions** Three home based interventions: Lifestyle integrated Functional Exercise (LiFE) approach (n=107; taught principles of balance and strength training and integrated selected activities into everyday routines), structured programme (n=105; exercises for balance and lower limb strength, done three times a week), sham control programme (n=105; gentle exercise). LiFE and structured groups received five sessions with two booster visits and two phone calls; controls received three home visits and six phone calls. Assessments made at baseline and after six and 12 months. **Main outcome measures** Primary measure: rate of falls over 12 months, collected by self report. Secondary measures: static and dynamic balance; ankle, knee and hip strength; balance self efficacy; daily living activities; participation; habitual physical activity; quality of life; energy expenditure; body mass index; and fat free mass. **Results** After 12 months’ follow-up, we recorded 172, 193, and 224 falls in the LiFE, structured exercise, and control groups, respectively. 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 saw a significant reduction of 31% in the rate of falls for the LiFE programme compared with controls (incidence rate ratio 0.69 (95% confidence interval 0.48 to 0.99)); the corresponding difference between the structured group and controls was non-significant (0.81 (0.56 to 1.17)). Static balance on an eight level hierarchy scale, ankle strength, function, and participation were significantly better in the LiFE group than in controls. LiFE and structured groups had a significant and moderate improvement in dynamic balance, compared with controls. **Conclusions** The LiFE programme provides an alternative to traditional exercise to consider for fall prevention. Functional based exercise should be a focus for interventions to protect older, high risk people from falling and to improve and maintain functional capacity. **Trial registration** Australia and New Zealand Clinical Trials Registry 12606000025538. ## Introduction Falling in older age has debilitating and isolating social consequences, along with high and escalating economic costs.1 2 Falls can start a downward spiral of immobility, reduced confidence, and incapacity leading to institutionalisation. Fall related admissions have not declined over the past ten years,3 and there is an imperative to develop effective strategies for fall prevention that are acceptable and sustainable over the long term for older people. The optimum exercise modality for falls prevention in older adults has been defined as balance enhancing activity and lower limb resistance training.4 However, the number of older people that routinely engage in strength training remains low at less than 10%5 and possibly much lower for activities that challenge balance. Those people older than 70 years who do engage in balance and resistance training are much more likely to be healthy and functionally capable than those who do not. Integration of exercise into lifestyle activities could enhance exercise adoption and adherence in other cohorts,6 7 8 but this approach has never been investigated in frail, older people at risk for falls. Therefore, we designed and tested the Lifestyle integrated Functional Exercise (LiFE) programme, which embeds balance and lower limb strength training into habitual daily routines. In a small pilot study,9 this alternate approach to traditional exercise had high potential to reduce falls (incidence rate ratio 0.23, 95% confidence interval 0.07 to 0.83), and a larger trial was needed to confirm the new approach’s effectiveness compared with placebo and to determine mechanisms of benefit. We hypothesised that a lifestyle integrated approach (using the LiFE programme) to balance and strength training would be more effective than a sham control programme (comprising of gentle exercise) in reducing falls in high risk people aged 70 years and over and living at home over one year. We further hypothesised that a traditional structured exercise programme would be as effective as LiFE in reducing falls, compared with the control programme; that intermediate outcomes of strength, balance, functional capacity, and quality of life would show equal benefit in LiFE participants compared with the structured programme; and that balance confidence in daily tasks and habitual physical activity levels would improve to a greater extent from the LiFE programme than from either the traditional or the control programme. ## Methods ### Trial design We conducted a three arm, randomised parallel trial with assessments measured at baseline, six months, and 12 months after randomisation. The study was approved by the University of Sydney human research ethics committee and registered on 20 January 2006. ### Participant recruitment, randomisation, and blinding Participants were recruited by mailings to Department of Veteran’s Affairs (DVA) Databases across the metropolitan area of Sydney, Australia, and three general practice databases inviting them to participate. DVA databases included veterans, their spouses, and war widows. Inclusion criteria were men and women aged 70 years or older and who had two or more falls or one injurious fall in the past 12 months, which was determined by self report. Exclusion criteria were moderate to severe cognitive problems (