Radhika Patil¹, Kirsti Uusi-Rasi 1,2, Kari Tokola¹, Pekka Kannus 1,3,4, Saija Karinkanta 1, Harri Sievänen 1 IFA

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Effects of a multi-component exercise program on physical function and falls among older women: a two-year community-based, randomized controlled trial Radhika Patil¹, Kirsti Uusi-Rasi 1,2, Kari Tokola¹, Pekka Kannus 1,3,4, Saija Karinkanta 1, Harri Sievänen 1 1 The UKK Institute for Health Promotion Research, Tampere 2 Research Department, Tampere University Hospital 3 Medical School, University of Tampere 4 Department of Trauma, Musculoskeletal Surgery and Rehabilitation, Tampere University Hospital, Finland IFA 2014 13.06.2014

The UKK-Institute for Health Promotion Research, Tampere, Finland DEX (Scandinavia, Northern Europe) Unit / Name of the author, Name of the author 10/12/2014 2

BACKGROUND AND PURPOSE In older adults, exercise may effectively reduce risk factors of falling, prevent functional decline, increase confidence and improve quality of life (QoL) Multi-component exercise programs can prevent falls in community-dwelling elderly populations, and seem to prevent fall-induced injuries The purpose of this randomized study was to assess the effects of multicomponent supervised exercise on falls and physical functioning among older home-dwelling Finnish women The Vitamin D and Exercise in Falls Prevention (DEX) study A 2-year randomized controlled vitamin D and open exercise trial of 409 homedwelling women 70 to 80 years of age (NCT00986466). Uusi-Rasi K et al. Study protocol for prevention of falls: a randomized controlled trial of effects of vitamin D and exercise on falls prevention. BMC Geriatr 2012;12:12. R Patil/IFA 2014, Hyderabad 13/06/2014

METHODS 409 women aged 70-80 years were randomly assigned to the exercise group (EX) or control group (CON) Inclusion criteria: At least one fall during the previous year Moderate to vigorous exercise 2 h/week No contraindication to supervised exercise EX group participated in supervised moderate-intensity group exercise classes 2/week for the first 12 months, 1/week for the last 12 months Training was progressive and consisted of strength, balance, agility and mobility training, home exercise plan practised on the rest days CON group asked to maintain previous levels of physical activity. R Patil/IFA 2014, Hyderabad 13/06/2014

R Patil/IFA 2014, Hyderabad 13/06/2014 DEX

Falls METHODS an unexpected event in which the participant comes to rest on the ground, floor or lower level Daily fall diaries returned monthly Fall-related injuries (bruises, abrasions, muscle or joint pain, head injuries, fractures) Injuries for which participants sought medical care (nurse, physician or hospital) Physical functioning Muscle strength: Maximal isometric leg extensor strength Mobility: Gait speed, TUG test, chair stand time Dynamic balance: 6.1 m backwards walking time Concern about falling: FES-I score (16-64) R Patil/IFA 2014, Hyderabad 13/06/2014

METHODS: Statistical analyses R Patil/IFA 2014, Hyderabad 13/06/2014

Fig 1. Trial Profile Invitation letter (n = 9730) Health history questionnaire to those willing to participate (n=1213) Initial assessment for eligibility by inclusion criteria Medical examination (n=433) Baseline assessment Not eligible (n=780) Excluded (n=16) did not fulfil inclusion criteria Withdrew (n=8) Lost interest Randomization (n=409) Exercise n=205 No exercise n=204 Lost interest n=5 Health reasons n=13 Lost interest n=6 Health reasons n=10 Died n=4 Spouse unwell n=1 24-month assessment n=187 24-month assessment n=183 R Patil/IFA 2014, Hyderabad 13/06/2014

RESULTS Table 1. Descriptive characteristics Variable EX CON Age, years 74.4 (2.9) 74.0 (3.1) Weight, kg 72.2 (10.6) 72.3 (12.7) Height, cm 159.6 (6.0) 160.0 (5.7) General health and functional status Number of diagnosed illnesses 2.2 (1.3) 2.2 (1.3) MMSE score, points 28.3 (1.4) 28.4 (1.6) ADL score (6-36) 6.9 (1.9) 6.8 (1.9) IADL score (8-48) 10.1 (4.0) 10.3 (3.9) Mobility score (4-24) 4.8 (1.7) 4.9 (2.0) Exercise-related activities, hours/week 14.2 (7.4) 14.3 (6.9) Average daily steps, n 5909 (2437) 5953 (2594) Physical functioning Maximal leg extensor strength/body weight 2.3 (0.6) 2.4 (0.7) Timed Up-and-Go test, s 8.9 (1.7) 9.2 (2.1) Normal gait speed, m/s 1.0 (0.2) 1.0 (0.2) Backwards walking test, s 29.8 (18.9) 28.8 (18.7) Concern about falling (FES-I) score (16-64) 23.0 (6.2) 23.7 (6.3) DEX R Patil/IFA 2014, Hyderabad 13/06/2014

RESULTS Table 2. Rates of falls and related injuries per year, incidence rate ratios (IRR) (95% CI) for falls and hazard ratios (HR) (95% CI) for fallers in the EX and CON groups during the 24-month intervention. Outcomes EX (n=205) CON (n=204) IRR or HR (95% CI) p-value Falls (per 100 person-years) All, n 233.8 250.3 1.00 (0.79 1.26)* 0.98 No consequences, n 113.9 123.1 0.98 (0.75 1.29)* 0.90 Resulting in injury, n 119.9 127.2 1.03 (0.79 1.35)* 0.83 Medical treatment sought, n 11.5 26.2 0.45 (0.27 0.78)* 0.004 Fallers all, n 140 141 0.99 (0.78 1.25) 0.94 sustained any injury 115 111 1.03 (0.79 1.34) 0.81 sustained fracture 8 12 0.66 (0.27 1.61) 0.36 sought medical treatment 20 39 0.45 (0.26 0.77) 0.004 fell 2 times 98 92 1.07 (0.80 1.42) 0.64 *IRR = incidence rate ratio; HR = hazard ratio R Patil/IFA 2014, Hyderabad 13/06/2014

RESULTS DEX Figure 1. Predicted percentage mean differences between groups in time for change in physical functioning outcomes. R Patil/IFA 2014, Hyderabad 13/06/2014

% change DEX RESULTS Backwards walking time (n=120, p=0.013) 0% -10% -20% EX CON -30% -40% 0 6 12 18 24 mo Figure 1. Predicted percentage mean differences between groups in time for change in physical functioning outcomes. R Patil/IFA 2014, Hyderabad 13/06/2014

RESULTS Training compliance: 73% for supervised exercise, 63% for home exercise Overall drop-out rate: 9.5% (18 EX and 21 CON) Falls for which participants sought medical treatment halved in EX No between-group differences in the rates of falls, injurious falls or fallers Falls resulting in fractures lower in EX group (n=8) compared with CON (n=13), but this did not reach statistical significance EX group s mean physical performance scores improved during the intervention, with the greatest improvements achieved between 12 18 months. Quadratic trend for reduced concern about falling (p=0.055), the difference being greatest at 12 months. R Patil/IFA 2014, Hyderabad 13/06/2014

CONCLUSIONS Exercise improved physical functioning and prevented age-related functional decline in older home-dwelling Finnish women Exercise reduced fall-related healthcare visits, although it did not reduce overall falls The trend for fewer fallers with fractures also suggested some benefit in preventing the most severe consequences of falls Training was feasible and safe for this age group. R Patil/IFA 2014, Hyderabad 13/06/2014

Thank you for your attention! Acknowledgements: The DEX research group, participants Academy of Finland Medical Research Fund of Tampere University Hospital Finnish Ministry of Education and Culture Juho Vainio Foundation National Doctoral Programme of Musculoskeletal Disorders and Biomaterials (TBDP) R Patil/IFA 2014, Hyderabad 13/06/2014