VOLUME 55 TO aoe 927-1090 OIE oy PXOoRs} Brisa GERIATRICS SOCIETY The Association between Obesity and the Frailty Syndrome in Older Women: The Women's Health and Aging Studies Apolipoprotein E Genotype and Mortality: Findings from the Cache County Study BUN air RM sO ee CCST eat EP Olean Me Tre OMG tems cetel nett Woy stots SS ipelieuire me Ceryeste-IPe lie ae Wa eer aT Randomized Clinical Tri: WUTC oue Rm Eels M an tN roe MN Ns cena Utena Notes Age on Commonly Used Diagnostic Tests and Ritossa Heterocyclics and Selective Serotonin Reuptake Inhibitors in the Treatment and Prevention of Poststroke Depression Where Does Research Occur in Geriatrics and Cerro costes www. blackwellpublishing.com/jgsA Simple Gait-Stabilizing Device Reduces Outdoor Falls and Nonserious Injurious Falls in Fall-Prone Older People During the Winter Fergus Eom MeKiernan, MD OBJECTIVES: To determine whether Yaktrax Walker YW), a nonmedical gait-stabilizing device, prevents our dloor fall and injurious falls i fall-prone older people duc ing the winter. DESIGN: Prospective, randomized, interventional rial. SETTING: Community-based, winter, outdoors. PARTICIPANTS: Ambulatory, community-dwellin and older. northern United States, fal prone people aged 6: INTERVENTION: Parcicipants were randomized to wear YW or their usual winter footwear (UWE) outdoors during, the winter of 2003/2004, MEASUREMENT: sfips, falls, and injurious falls was recorded daily im a fall liars, Winter foorwear satisfaction strvey was completed after study completion, RESULTS: One hundred nine subjects completed 10,724 diary days. Mean age was 74.2. There were 93 indoor slips, 1B indoor falls, 714 outdoor slips, and 62 outdoor falls. The tendency for both groups to slip/fall indoors was compa: rable. The relative risk (RR) of outdoor slip for YW was 0.50 (P'<.04) for all diary days and 0.61 (P=.14) when only days walked on snow and ice was the exposure 9’ ble. The RR of outdoor fall for YW was OA2 (P<.0 when only days walked on snow and ice was the exposure variable, RR of injurious falls per day walked on snow and, ice for YW was 01,13 (P=<.02), Twelke of 19 outdoor falls, occurred when YW subjects were not wearing their as signed device. No serious injury or fracture oecurred in et ther group. The number needed to rreat for the YW ro. prevent one nonserious injurious fallin one winter Was six CONCLUSION: YW may reduce the risk of outdoor wine falls, and of nonserious injurious falls in older commu nity-chvelling people with a history of previous falls. J Am, Geriatr Soe 53:943-947, 2005, he number of indoor and outdoor From ehe Center tor Bone Dnsasey Marah Cink, Manik, Waconsn, Fanded by che Mashed Clinic Research Fomadaion, Adress contespondence to Fes Faun Meicnan, MD, Cee for Tne Discs Marl Clan 1090 Noth Oak Aven, Matched, WT 54449 a jae eee tere DOK 10.11114.1532-5415.2005 Wes s3a Key words: falls; nonserious injurious falls; older people; winter; Yaktrax Walker Frits eating cane of accdenal death ad te sixth leading cause of all deaths in older people (aged 155) in the United States." Approximately 20% of falls in ‘older people require emergency meclical attention, anid 30°% to 50% of these result in hospitalization. Five percent to 10% of falls in older people result in serious soft tissue injury, 3% to 5% in skeletal fracture, an! 1% co 2% in hip fracture.'~* Conversely, a fall precedes 90% of hip fra tures’ and 25% to. 40% of verteheal compression frac- tures." Ifa person has low bone mineral density the risk of hip facture resulring from a fall is tripled,” The personal, family, and societal consequences of fractures in older peo ple, particularly hip fracture, can be devastating. Therefore, important facet of any osteoporotic fall prevention is fracture reduction scheme The predisposition co fall represents a complex inter play of environmental conditions, visual acui cular agility, and strength that iatrogenic factors such as polypharmacy can aggravate. In dry environmental cond tions, fall-prevention strategies have resulted in fewer frac tures.* Similar trials in hazardous winter conditions have not been published. Falls may oceur more frequently in the winter in northern latitudes because of more hazardous en: Vironmental conditions and suboptimal sitamin D- sta tus." Improving gait stability in these conditions should result in fewer falls and injuries. Recently, he American and. British Geriatric Societies and American Academy of Or thopedic Surgeon's Panel on Falls Prevention published guidelines For the prevention of falls in older persons." One ‘of 12 questions that this panel identified as high priority for future research was “What isthe safest footwear for people who have fallen or are at risk for falling?” The purpose of this study is to determine whether a simple, nonmedical device designed to improve gait stability in hazardous win ter conditions (Yakteax Walker (YW), Figure 1)!" reduces ‘outdoor slips and falls oF results in fewer injurious falls in . ambulatory older people fall-prone, community-dwvelli 61 408115.00Figure 1. The Yakerax Walker METHODS: “The Marshfield Clinic Research Foundation institutional review board approved this study procacal. The prospective study was condicted at Marshfield Clinic, Marshfield, W consin (ltitde 4449175 N) ancl Marshfield Clinic Lake land Center, Minocqua, Wisconsin (latitude 45.82466 N) luring the winter of 2003/2004. A fal registry was con structed froma darabase of community dwelling older peo- ple who had fallen at least once ducing the previous year and had been evaluated in clinic urgent care or primary’care centers or in either of two aliated hospieal emergency de- partments. Participants were recruited from the fall egistry using a single clicect mailing and in response to a sin announcement in Ioeal print media. Respondents were italy sereened by telephone incerview to confirm that they were aged 65 and older, community dwelling, and inde- pendently ambulatory and had sustained at least one (in door or oucdoor) fall within the preceding year. Falls were defined as any unintentional assamption of the nonupright position on the ground oF any other intervening surface Slips were defined as any unintentional deviation from the upright positon that would have resulted in a fallin the absence of an immediate correetive action, Candidates had ‘o be willing ro aecept assignment tothe intervention (YW) winter footwear (UWE)) group and not to enroll withthe a prior intention of violating che assignment. YW (Figure 1) isa proprietary inection-mold- ed chermal plastic elastomer netting sized to conform to the external length and width of a boot or shoe. High strength coils encase the netting in a configuration intended t0 pro vide multidirectional gait stabiliy under outdoor winter conditions. Study candidates had to be capable of applying the YW correctly and to discern appropriate outdoor conditions for their use according t0 manufacturer's recommendations. Candidates had to be able and vwlling to: maintain a fall diary and accurately record all indoor and outdoor slips and falls throughout the study duration, the surface upon which the fall occurred, footwear worn’at the time of the ship or fall (including use ofthe YW or similar device), and any {allerelated injuries. Candidates who satisfactorily met all inclusion criteria were randomized using independent nu ‘or noningervention (usu: WUNEIS-VOL, $3, NO.6 _1AGS ‘merical assignment ro wear YW under appropriate envi ronmental conditions or their UWF outdoors during the winter of 2003/2004. Yakrrax, Inc. provided each YW study subject wich one pair of appropriately sized YWs ancl agreed to replace that pair in the event of device failure Sabjects were strictly counseled never to wear YW indoors ‘oF on smooth outdoor nonice surfaces, Subjects were al- lowed to reside outside of the immediate geographic region for up co L month during the study duration without dis- qualification, All subjects completed a footwear satisaction survey after study termination. After receipt of all com- pleted fall diaries and footwear satisfaction surveys, each study subject was nominally compensated ($20) for the in- conveniences incurred because of study participation, Inju- rious falls were rated as mild (no medical attention), ‘moderate (medical attention), or serious (hospitalization) Indoor slip and fall raves served as the control to compare the tendeney to fall between groups. Subjects whose indoor slip or fall rare exceeded the geoup mean by more than 3 d_deviations were considered outliers and were excluded from final a . on am intention. to-treat asis. Chi-sq tive Binomial Model, and Fisher exact tests using SAS software (SAS Institute, Inc., Cary NC) were used co test the difference of outcomes be- raven intervention and nonintervention groups, Yaktrax, Inc. had no involvement in the conception, design, imple mentation, or analysis of the study and had no invelyement in the preparation or review of the manuscript, Neither the author nor his institution has any director indirect financial are, Ne interest in Yakteax, Ine. or received any compensation from Yaktrax, Ine. or any other commercial interest in conduct- his research, RESULTS ‘One hundred thirteen subjects met inclusion criteria and were randomized. Four randomized subjects were excluded from the final daca analysis: wo UWE subjects met the test for exclusion as outliers, one YW subject withdrew consent after randomization, and one UWE subject completed only 10 diary days, The final study population consisted of 109) older people, of whom 65 (60%) were female and 44 (40%) male. Mean subjectage was 74.2 (range 65-96). Ninety-five percent of all fall diaries and footwear satisfaction surveys, were completed and returned for analysis. OF those as signed to wear YW, 78% confirmed that they had used the YW as their primary winter footwear during the course of the study under appropriate environmental conditions. OF those assigned to UWE, 19% admitted hac they had used the YW or a similar gaiestabilizing device during the course of the study. The difference in use of the YW between groups was highly significane (P-<.001). Throughout 10,724 obser \ation-days, there were a total of 93 indoor slips, 13 indoor falls, 714 outdoor slips, and 62 outdoor falls. ce was the most common surface involved in outdoor slips and falls in both groups. Boots (with or without the YW) were the most commonly worn footwear at the time of ontdoor slips and falls in both groups. Age, sex, and foorwear assignment did not influence mdoor ship and fall rates. Compaced with the UWF group, the relative risks (RRs) for indoor slips and indoor falls in the YW group were 147 (P=.45) and 1.19 (P=,78), respectively, indicating that the tendeney for both‘Table 1, Indoor Slip and Fall Rates and Relative Risks (RR) i Footwear Group Yaktrax Walker Group Compared with Usual Winter Indoor Slips Indoor Falls Diary Days: ae Group A (RR) Yaktrax Walker (n= 55) 5.958 55 (1.47)" 71.19) Usual winter footwear (n= 54) 5,966 38 (1.0) 6(1.0) Wald 99% conten ers) = U.SS-RBT, >A groups to slip or fall indoors was comparable (Table 1). Age ‘lid not influence outdoor slip and fall rates. Men slipped and fell more often than women ourdoors, with RRS of 1.5 (P-<.02) andl 4.0 (P-<.001), eespectively. Compared with the UWE group, the RR of outdoor slips in the YW group was 10,50 (P-=.04) when all diary days was used as the exposure variable (Table 2). When the exposure variable was only those days walked on snow and iee, the RR of outdoor slips in the YW group was 0.61 (P?=.14) (Table 3). The RRs of ‘outdoor falls in the YW group were 0.45 (P-<.02) using all tary days as the esposure variable and 0.42 (P'<.03) when only days walked on snow and ice, was the exposure var able. Approwimately one-thied of all outdoor slips and ewo- thieds ofall outdoor falls recorded in she YW group occurted when subjects were nr wearing their assigned device (Table 4), Falls resulted in 10 injuries (8 mild, 2 moderate) in the URW group and one mild injury in YW group. No serious, injury oF fracture occurred in either group. The RR of a onserious injurious fall over the course of the winter in subjects assigned to wear the YW was 0.10 (P-<.02). The RR, ‘of a nonserious injurious fall per day walked on snow and ice for YW was 0.13 (P<.02). The number of persons that had to be assigned to wear the YW (number needed to treat (NNT) to prevent one nonserions injurious fall per win was six, The NTs to prevent one wintertime outdoor slip ‘or outdoor fall were 1 and 3, cespectively (Table 3) ighty percent of the YW group bus only 40% UWE group felt strongly chat chey planned to use their as of che signed winter footwear the following winter (P-<.001), Sixty-three percent of the YW group bur only 26% of the UWE group indicated that they got outdoors more often because of their assigned footwear (P<,001), Seventy-four percent of the YW group but only 18% of the UWF group. strongly agreed that they felt very secure while walking ‘outdoors during the winter (P-<.001). Both groups agreed that applying their assigned footwear was easy, although ss $4%; P-<,01), There device replacement, and no device fare contribuced to a slip, fall, or injury the difference favored YW (80 ‘were three device failures requirin CONCLUSION These results indicate th abilizing device (VW) can prevent outdoor falls and nonserious injurious a simple falls in fall-prone, ambulatory older people when carefully applied and worn under appropriate environmental condi ns. Strengths of this study include che unusually high d sentative outdoor winter conditions during the course of the jure of the study: pop- ulation. The reported magnitude of outdoor fall reduction gece of patticipanc compliance and follow-up, the repre- study, and the community-based 1. in this study is likely conservative because the majority of ‘outdoor falls in the YW group oceursed when subjects were not wearing their assigned dlevice. Furthermore, a substan tial number of subjects assigned to the UWF group ind cated thar they had used YWs of similar gait-stabilizing devices during the course of the study. In this later group, seven outdoor slips in five subjects were recorded, but there ‘were no outdoor falls. This unintended crossover likely ed the measured beneficial effect af the device, The absolute magnitude of fall reduction and thus the NNT to prevent falls and injurious falls will vary with the propen- sity to fall in the population using the device. This study population was enriched with fall-prone older people, 90 Similar benefits may not be appheable to a less-fall-prone population. Conversely, a frailer or older population might hot find application of the YW to be as straightforward. Misapplication of the device or failure 10 recognize device failure might increase the risk of fall There were no serious injurious falls or fractures in this study; Ie has been estimated thar, each year, 5% of older people in Wisconsin experience a fall that results in hosp eee Table 2, Outdoor Ship, Fall, and Injurious Fall Rates and Relative Risks (RRs) in Yaktrax Walker Group Compared with Usual Winter Footwear Group Using All Diary Days as the Exposure Variable Total Outdoor Slip Total Outdoor Fall Total Outdoor injurious Fal Total Diary Days. Group n (RR) Yakirax Walker (n= 55) 5,358 229 (0.50)° 19 (0.45) 10.1) Usual winter footwear (n= 54) 5,306 485 (1.0) 43.(1.0) 10 (1.0) eral (Ch SPJUNE2@5-VOL 5%, NOL6 —_INGS ‘Table 3. Outdoor Slip, Fall, and Injurious Fall Rates and Relative Risks (RR) in Yaktrax Walker Group Compared with Usual N ‘er Footwear Group Using Only Days Walked on Snow and Ice as the Exposure Variable Total Outdoor Total Outdoor Total Outdoor Slips” Falls Injurious Falls Total Diary Days, Group n BR Yaktrax Walker (n= 55) 3.634 229 (0.617 19 (0.42) 40.13)" Usual winter footwear (n= 54) 4274 435 (1.0) 43 (1.0) 10(1.0) ome pean nus wcse Yaka Walker sow nde to prevent eli all oc nomsenowsijanous fall over the course one winter umber node tsar NNT SNNT-=1 (48% condense neva (C1) = tt talloss c= talization.!2 One-quarter of these falls occurred during January, February, and March, so 1-4 fall-relaced hospital izations might have been anticipated duu the current study. Considering the significant reduction of onserious injurious falls in the YW group, the current study was probably underpowered so detect a significant differenc n falls that result m hospitalization becween the ion and nonintervention arms, The average est: mated medical cost for fall-relaced emergency department valuation in older people is $9,400!” and for fall-related, hospitalization is $19,440." The manufacturer's current stuggested retail price for the YW is less than $20 per pair." Given a NNT of six, these data suggest that it may cost less than $120 to prevent one nonserious injurious fall in a population of fall-prone older people during one winte From 2000 to 2040, the number af people aged 65 and older is projected to increase from 35.1 million to 86.7 million."° In 1999, Medicare spent more than $8 billion an, ‘of injuries to older people (6% of all Medi- care fee-for-service claims), and ‘wo-thirds of this cost!" Falling and fall-related consequences will constitute an Ichcare system. Fall-reduction strategies should result in fewer serious injuries, fractures, and fatalities and an increase in healthcare savings. Target ing the most appropriate fallereduction intervention to the right population should yield the best rate of therapeutic return, Under appropriate environmental conditions, YW appears to be an inexpensive means of preventing falls and the treatme ruires accounted for increasing burden on the he ‘Table 4. Status of Yaktray Walker at the Time of Outdoor Slip and Fall Total Total (Outdoor Slips ‘Outdoor Falls (n= 229) (n=19) Wearing Yakirax Walker f Yes 145 7 No 80 12 Uncertain 4 ° nonserious injurious falls in fall-prone, ambulatory, com munity-dwelling older people during the winter. ACKNOWLEDGMENTS The author gratefully acknowledges the contributions of Hong Liang, PhD, for statistical works Mss. Deb Krieg, Sheryl Souhrada, Pamela Munds, and Deb» Tauschek for patient re tions Lorelle Benetti for statistical programming; Richard Fossen, MD, and Thomas Gabert, MD, for securing off-site I review board approval; and Ms. Michelle Isandt for secretarial work, The Marshiield Clinic Research Foundation Physician Research Eund funded this study internally. Yakteax, Inc c. Yaktrax, Inc. provided jtment and retention and research coordina Wel provided the devices free of charge Marshfield Clinic Research Foundation with $20 per sub. ance of study partic~ ject to compensate for the inconver ipation. The subjects received their blinded compensation after completion of the study. Yaktrax was nor the study sponsor nor did ithave any role mn design, methods, subject recruitment, cata collections, analysis, or preparation of this manuscript. REFERENCES 1. 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