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1 Cliical Sectio / Origial Paper Received: September 21, 2015 Accepted: December 22, 2015 Published olie: March 11, 2016 Log-Term Effects of Idividually Tailored Physical Traiig ad Activity o Physical Fuctio, Well-Beig ad Cogitio i Scadiavia Nursig Home Residets: A Radomized Cotrolled Trial Kersti Frädi a Helea Gröstedt a, b Joru L. Helbostad c, d Astrid Berglad e Mette Adrese f Lis Puggaard g Kari Harms-Rigdahl a, b Radi Grabo h Kari Hellström i a Departmet of Neurobiology, Care Scieces ad Society, Karoliska Istitutet, ad b Departmet of Physiotherapy, Karoliska Uiversity Hospital Huddige, Huddige, Swede; c Departmet of Neurosciece, Norwegia Uiversity of Sciece ad Techology, ad d Cliical Services, Departmet of Geriatrics, St. Olav Uiversity Hospital, Trodheim, ad e Faculty of Health Sciece, Oslo ad Akershus Uiversity College, Oslo, Norway; f Departmet of Research ad Iovatio, Uiversity College Sjaellad, Naestved, ad g Uiversity of Souther Demark, Odese, Demark; h Faculty of Health Educatio ad Social Work, Sør-Trødelag Uiversity College, Trodheim, Norway; i Departmet of Neurosciece, Uppsala Uiversity, Uppsala, Swede Key Words Idividually tailored physical activity Physical fuctio Nursig home Well-beig Abstract Backgroud: The preservatio of physical fuctios such as muscle stregth, balace ad mobility is fudametal to maitaiig idepedece i activities of daily livig (ADL). The physical activity level of most ursig home residets is very low, which implies that they are ofte subject to a declie i health, mobility, autoomy ad social cotacts ad are also at risk of sufferig a declie i metal well-beig. I a previous study, we demostrated that trasfers, balace ad physical activity level improved after 3 moths of idividually tailored itervetio i ursig home residets. Ob- karger@karger.com S. Karger AG, Basel X/16/ $39.50/0 jective: To evaluate the log-term effects o ADL, balace fuctio, physical activity level, physical performace, fallsrelated self-efficacy, well-beig ad cogitive fuctio 3 moths after the completio of our itervetio i ursig home residets. Methods: The study was a multiceter radomized, cotrolled cliical trial with a parallel-group desig. It was coducted i ursig homes i Swede, Norway ad Demark, with a itervetio period lastig 3 moths ad a follow-up at 6 moths. Iitially, 322 ursig home residets with a mea age of 85 years were icluded; 85 from Swede, 171 from Norway ad 66 from Demark. Of these, 241 [129 itervetio group (IG), 112 cotrol group (CG)] were eligible for the 6-moth follow-up tests. The level of depedece i ADL, physical activity level, several dimesios of physical fuctio, well-beig, falls-related self-efficacy ad cogitive fuctio were assessed with reliable ad Kersti Frädi Neuropsychiatric Epidemiology Uit, Istitute of Neurosciece ad Physiology Sahlgreska Academy at Göteborg Uiversity, Wallisgata 6 SE Möldal (Swede) euro.gu.se

2 valid istrumets at baselie, immediately after 3 moths of itervetio ad 3 moths later at the 6-moth follow-up. Results: After 3 moths of itervetio ad a additioal period of 3 moths without itervetio, oly the followig 2 variables demostrated sigificat group differeces: social ad cogitive fuctio, measured by the Fuctioal Idepedece Measure -r, where the IG deteriorated while the CG was almost stable. However, regardig trasfers, the IG deteriorated sigificatly less tha the CG. Coclusio: Without supervised physical exercise that challeged the idividuals capability, gais i ADL fuctio, balace ad trasfer ability deteriorated durig the 3 moths followig the itervetio period. Thus, cotiuous, idividually adjusted ad supported physical activity seems crucial for the maiteace of physical fuctios i these vulerable elderly persos S. Karger AG, Basel 2 Itroductio Physical fuctios such as muscle stregth, balace ad mobility are fudametal to the maiteace of idepedece i activities of daily livig (ADL), ad physical activities performed as a itegrated part of daily life are crucial i order for ursig home residets to maitai idepedece, or to become less depedet i ADL, which could also lead to a heighteed feelig of self-esteem [1]. A high level of physical activity is associated with the preservatio of physical fuctioig i daily life [1 3], a low prevalece of depressive symptoms [4, 5], reduced axiety ad ehaced mood ad self-esteem [6], ad is also positively related to metal health ad wellbeig [7]. A systematic review directed towards older adults i ursig homes foud sigificat improvemets i muscle stregth ad fuctioal performace outcomes, icludig chair stad, stair climbig, gait speed, balace ad fuctioal capacity followig progressive resistace traiig exercise. This occurred despite advaced age, presece of chroic diseases, extremely sedetary habits ad fuctioal disabilities [8]. Older people who are physically active ad sped less time sittig dow experiece higher levels of self-rated metal health ad well-beig tha those who are less active [9]. A Swedish study amog persos aged 85 ad older showed a 27% prevalece of depressio i commuity-dwellig elderly persos ad a 42% prevalece amog those livig i istitutios [10]. I spite of this, ursig home residets sped up to 94% of their daytime sittig or lyig dow, eve if may are capable of idepedet or assisted activity [11, 12]. Idividuals with demetia, commo i ursig home settigs, have higher levels of fuctioal depedece tha others ad are more likely to require assistace i task-specific ADL domais such as mobility ad persoal care [13, 14]. It has, however, bee demostrated that older persos with severe cogitive or physical impairmets ca beefit from a high-itesity fuctioal exercise program [15]. A systematic review cocluded that it is uclear whether physical exercise ca improve cogitive fuctios i people with demetia [16]. I our previous study i ursig home residets, we demostrated a sigificat group differece regardig balace, physical activity level ad trasfers directly after 3 moths of idividually tailored itervetio, where the itervetio group (IG) had improved but the cotrol group (CG) had deteriorated [17]. We also demostrated that low physical activity levels, impaired physical fuctioig ad a high degree of depedece i ADL at baselie were associated with a impaired cogitive fuctio [18]. However, it is also essetial to assess whether the gaied effects remai eve without cotiuous, supervised traiig. Thus, the aim of the preset study was to evaluate the log-term effects o ADL, balace fuctio, physical activity level, physical performace, falls-related self-efficacy, well-beig as well as cogitive fuctio 3 moths after the completio of our itervetio i ursig home residets. Methods Desig ad Sample The study was a multiceter radomized, cotrolled cliical trial with a parallel-group desig addressig ursig home residets from city areas i Swede, Norway ad Demark. Participats from 24 ursig homes (4 Swedish, 9 Norwegia ad 11 Daish) i the 3 coutries were radomized to either a IG or a CG. Iclusio criteria were as follows: (1) age over 64 years; (2) eed of daily assistace i a miimum of oe persoal ADL (P- ADL); (3) expected stay i the ursig home durig the study period. Residets at a termial stage of disease were excluded. I Demark, a Mii-Metal State Examiatio (MMSE) score <16 poits was added as a extra exclusio criterio followig a decisio made by the Regioal Ethics Committee. Thirty percet of the ivited residets declied to participate. Baselie data from 322 residets (237 wome, 85 me) were collected; 85 from Swede, 171 from Norway ad 66 from Demark. Of these, 241 (75%) were eligible for the 6-moth follow-up test. The mortality rate durig the study period was 8 participats i the IG ad 10 i the CG ( fig. 1 ). The study desig has bee fully described i a previous article [19]. The project was approved by the ethics committees i all participatig coutries, ad the study is registered uder Cliical Trials.gov (idetifier: NCT ). Frädi et al.

3 Assessed for eligibility ( = 419) Declied to participate ( = 97) Radomized ( = 322) Itervetio group ( = 170) Cotrol group ( = 152) Dropouts ( = 27) Ad mortem: 5 Refusal to participate: 2 Moved: 1 Acute disease: 1 Ukow cause: 18 Dropouts ( = 29) Ad mortem: 7 Refusal to participate: 5 Moved: 1 Acute disease: 0 Ukow cause: 16 Aalyzed at 3-moth follow-up ( = 143) Aalyzed at 3-moth follow-up ( = 123) Dropouts ( = 14) Ad mortem: 3 Refusal to participate: 2 Moved: 1 Acute disease: 0 Ukow cause: 8 Dropouts ( = 11) Ad mortem: 3 Refusal to participate: 2 Moved: 0 Acute disease: 0 Ukow cause: 6 Aalyzed at 6-moth follow-up ( = 129) Aalyzed at 6-moth follow-up ( = 112) Fig. 1. Flow chart of the participats icluded i the trial. Itervetio I additio to the ordiary care ad treatmet that were give to both groups, the IG was offered idividually tailored physical ad daily activities [19]. A team comprisig 1 physiotherapist (PT) ad 1 occupatioal therapist (OT) was resposible for the itervetio at each locatio. Whe a residet was icluded i the IG, cliical assessmets were carried out by both the PT ad the OT, ad a idividual treatmet goal was set i cooperatio with the participat. The idividually tailored programs cosisted of physical ad daily activities i differet combiatios, depedig o the goals ad physical ad cogitive fuctio of each participat. The PT ad OT resposible for the itervetio recorded the total umber of miutes each participat spet o each category of itervetio [19]. Idividually Tailored Physical Traiig i Nursig Homes Primary Outcomes ADL was described accordig to the Fuctioal Idepedece Measure (FIM) [20 21]. FIM describes residets performace accordig to a 7-poit scale, where grade 1 meas total assistace ad grade 7 meas full idepedece. The istrumet cosists of 18 items, of which 13 address physical fuctio (items a m) ad 5 social ad cogitive fuctios (items r). Both subscales were used separately i our aalysis. Participats with results from less tha 75% of the items were excluded. I the preset study, evaluatio was doe by the ursig home staff, primarily by the perso workig closest to the residet. Fuctioal balace was evaluated with the Berg Balace Scale (BBS) [22]. I order to iclude as may test scores as possible i the aalysis, we replaced missig values o item 3 (= seated without support) i empty protocols accordig to participats results o the Physiotherapy Cliical Outcome Variables (COVS) [23] item 3. If participats had 3 poits ( able to perform movemets i a sittig positio withi the support surface ) o COVS, they received 3 poits o BBS. If they had 5 7 poits ( able to perform movemets i a sittig positio beyod the support surface ) o COVS, they received 4 poits o BBS. 3

4 Secodary Outcomes Physical activity level was assessed with the Nursig Home Life Space Diameter (NHLSD) [24]. The NHLSD describes the extet ad frequecy of a perso s patter of movig aroud i specified areas (i.e. his/her room, the corridor or outside the ward) durig the previous 2 weeks, accordig to a 6-poit gradig scale ragig from 0 (ever) to 5 (>3 times a day). Depedece o huma assistace durig the activity is dichotomously recorded as 0 = idepedet/1 = depedet. The NHLSD is divided ito two subscales: semi-total, which addresses the area where the participat is movig aroud (max 50 poits), ad total, which adds iformatio about the eed of assistace i this activity (max 100 poits). High scores o the scale idicate a high physical activity level. Trasfers were assessed with COVS [23, 25], which covers 13 differet activities related to trasfers. Each item is scored o a scale ragig from 1 to 7, ad with a sum score ragig from 12 to 91, where a high score idicates good ability. Participats with more tha 3 items missig o the scale were excluded from the calculatios. Walkig ad wheelchair propulsio at self-selected ad at maximum speeds (m/s) was tested for 10 m idoors [26]. Leg muscle stregth was evaluated with the Timed Chair Stad Test [27]. Subjects were asked to stad up from a chair 5 times i a row as quickly as possible. The total time i secods was used as outcome. Falls-related self-efficacy was assessed with the Swedish versio of the Falls Efficacy Scale [FES(S)], which cosists of two subscales (P-ADL, I-ADL) [28, 29]. Participats with more tha oe item missig o a subscale were excluded from calculatios. The results from FES(S) total were used for aalysis. Well-beig, i.e. morale, is ofte used syoymously with psychological well-beig, quality of life ad life satisfactio [30], ad it reflects a idividual s perceptio of physical ad metal health [31]. I this study, the defiitio of well-beig ad morale accordig to Lawto [32] was used. It was measured with the Philadelphia Geriatric Ceter Morale Scale (PGCMS), which is a scale suitable for older people ad those with memory loss [32]. It icludes 17 items (questios) with two respose alteratives (yes/o), ad the maximum score is 17. Missig aswers were cosidered to be 0. A total score betwee 13 ad 17 poits represets high morale, poits middle rage morale ad 0 9 poits low morale. The Swedish versio of the scale has bee foud to have satisfactory iter-rater reliability [33]. Cogitive fuctio was assessed accordig to MMSE, a brief screeig test that quatitatively assesses the severity of cogitive impairmet ad documets cogitive chages over time. It rages from 0 to 30, where high scores idicate good cogitive fuctio [34]. The severity of cogitive impairmet ca be classified ito three levels: = o cogitive impairmet; = mild cogitive impairmet, ad 0 17 = severe cogitive impairmet [35, 36]. Backgroud Variables Data o the age of the participats, legth of stay i the ursig home, umber of diagoses ad drugs were obtaied from medical records. Sample Size ad Power Calculatio A estimate of power of 80% based o assumptios of detectig group differeces i ADL, with a alpha value of 0.05, showed that subjects i each group would be a sufficiet umber [19]. I order to detect group differeces of 3 poits for BBS [37], 155 participats would be a sufficiet umber i each group. Radomizatio Eligible participats were idetified accordig to the iclusio criteria ad ivited to participate by ward staff. After the baselie assessmet, participats were categorized ito either idepedet or depedet o persoal assistace i mobility (i.e. walkig or wheelchair propulsio). Participats were the stratified accordig to geder ad level of depedece i ADL. After the stratificatio, radomizatio was carried out withi each ursig home ward by the researcher at each ceter, accordig to radom sample lists provided by a statistical adviser [19]. Procedure Iformed coset was obtaied from all participats or from sigificat others whe the participat was diagosed with demetia. Research PTs or OTs employed for the study assessed all participats, at baselie, durig the week immediately after the ed of the 3-moth itervetio period ad 6 moths after eterig the study. The assessors were traied i the test procedures before the start of the study i order to secure high iter-tester reliability [19]. Blidig The assessors were blided to the group assigmet ad ot ivolved i the itervetio. Statistical Aalysis Descriptive statistics were used for computig frequecies, cetral tedecy ad variability. Mea chage was preseted as the differece (positive or egative) betwee the participats baselie values ad the values at 6-moth follow-up for each measuremet. The two-sample t tests, Ma-Whitey U test ad χ 2 test were used to assess betwee-group differeces i chage. Withi-group differeces were calculated accordig to the Wilcoxo siged-rak test. Rak tests were used because of ordial scale data outcome measures or o-ormality distributio of cotiuous scale variables. To check the sesitivity of usig rak tests, we also compared the result of mixed models for repeated measures with group, time ad the iteractio betwee time ad group beig modelled as fixed effects. Both methods gave the same results. The level of sigificace was set to p Statistical aalysis was performed with the Widows 22 versio of SPSS Software (SPSS Ic., Chicago, Ill., USA). Missig data were hadled as described uder Measuremets, ad i some cases replaced by media scores [38], as described i a previous article [18]. The itetio to treat (ITT) aalysis was doe by the last value carried forward method. Results Itervetio Due to loss of data at oe of the ceters, the iformatio regardig the duratio ad frequecy of the activities performed accordig to each idividual s activity program is preseted for 100 of the participats who com- Frädi et al.

5 Table 1. Baselie characteristics of the IG ad CG IG ( = 129) CG ( = 112) p (%) media (rage) mea ± SD (%) media (rage) mea ± SD Age, years (65 101) 85 ± (64 98) 84.5 ± Female sex 91 (70.5) 88 (79) Legth of stay, moths (0 252) 27.2 ± (0 186) 24.5 ± Number of diagoses (1 7) 3 ± (1 7) 2.6 ± Number of drugs 88 6 (0 14) 6.3 ± (0 18) 6.8 ± Able to walk 84 (75) 73 (77) Able to rise from a chair 81 (64) 66 (59.5) FIM items a m (13 90) (13 91) FIM items r (5 35) (5 35) BBS (0 56) (0 54) NHLSD semi-total (0 50) (0 50) NHLSD total (5 100) (0 100) COVS (15 91) (13 91) Walkig/wheelchair propulsio Self-selected speed, m/s ( ) ( ) Maximum speed, m/s ( ) ( ) The Timed Chair Stad Test, s (8 219) (8 187) FES(S) (0 130) (0 130) PGCMS (2 17) (0 17) MMSE (0 29) (0 30) Idepedet t test; 2 χ 2 test; 3 Ma-Whitey U test. p values <0.05 were cosidered sigificat. pleted the whole 6-moth study. Of these, 74 took part i weeks of itervetio with a mea of 93 mi/week (SD 60.1). The most commo itervetio was focused o decreasig activity limitatios such as trasfers, walkig ad persoal care [16]. Illess, acute hospital admissio ad uwilligess to cotiue to participate i the study were the most commo reasos for ot completig the whole itervetio period [16]. No major adverse evets associated with the prescribed exercises ad activities were observed. Characteristics of the Study Populatio There were o sigificat differeces betwee the IG ( = 129) ad CG ( = 112) regardig baselie values ( table 1 ). The mea age was 85.0 (IG) ad 84.5 years (CG), mea legth of stay 25.0 (IG) ad 24.4 moths (CG), ad about 75% were females. The participats had o average 3 medical diagoses ad used 6.5 drugs. About 75% were able to walk with or without walkig aids, ad aroud 60% were able to rise from a chair idepedetly. The media PGCMS score was 11 poits for both groups, which idicates middle-rage morale, ad 19 poits o Idividually Tailored Physical Traiig i Nursig Homes MMSE, which idicates mild cogitive impairmet ( table 1 ). Aalysis of iteral dropouts revealed that those who did ot complete the 6-moth follow-up had a higher cogitive level (MMSE, p = 0.03; FIM r, p = 0.007) but walked more slowly (p = ad 0.05) tha those who completed the 6-moth follow-up. Participats i the IG who dropped out before the 6-moth follow-up had completed fewer weeks of itervetio tha those who completed the whole study period. Log-Term Effects Betwee-Group Differeces Regardig All Outcome Variables There were o sigificat differeces betwee the IG ad CG i mea chage from baselie to the 6-moth follow-up, with two exceptios. While the IG deteriorated i social ad cogitive fuctios, measured by FIM r, the value for the CG was close to stable (p = 0.008). I cotrast to the per protocol aalysis, the ITT aalysis showed a sigificat differece i trasfers (COVS, p = 0.042), i favor of the IG. No other chages i the results were revealed by the ITT aalysis ( table 2 ). 5

6 Table 2. Compariso betwee the IG ad the CG regardig mea chages from baselie to the 6-moth follow-up: aalysis per protocol ad ITT Outcome variables IG CG IG-CG ITT, mea chage±sd ITT, mea chage±sd ITT, mea chage±sd ITT 1, mea chage±sd ITT, FIM items a m ± ± ± ± FIM items r ± ± ± ± BBS ± ± ± ± NHLSD semi-total ± ± ± ± NHLSD total ± ± ± ± COVS ± ± ± ± Walkig/wheelchair propulsio Self-selected speed, m/s ± ± ± ± Maximum speed, m/s ± ± ± ± The Timed Chair Stad Test, s ± ± ± ± FES(S) ± ± ± ± PGCMS ± ± ± ± MMSE ± ± ± ± High scores o PGCMS idicate a higher level of well-beig; a high score o MMSE idicates a better cogitive fuctio; a high score o FIM or COVS idicates a high degree of idepedece i ADL; a high score o the BBS idicates a better balace fuctio; a high score o the NHLSD idicates a high physical activity level ad more idepedece i mobility; a high score o FES(S) idicates a high degree of fall-related self-efficacy. NHLSD semi-total = Extesio of physical activity; NHLSD total = extesio ad depedecy i physical activity. 1 Ma-Whitey U test, sigificace level <0.05. Withi-Group Differeces Regardig All Outcome Variables Withi the IG, the results of social ad cogitive fuctios (FIM r, p = 0.001) deteriorated from baselie to the 6-moth follow-up. The ITT aalysis did ot chage the results ( table 3 ). Withi the CG, the results for physical fuctio (FIM a m, p = 0.031), fuctioal balace (Berg, p = 0.014) ad trasfers (COVS, p = 0.003) deteriorated sigificatly from baselie to the 6-moth follow-up. The ITT aalysis did ot chage the results ( table 4 ). 6 Discussio The preset study shows that after 3 moths of itervetio ad a additioal period of 3 moths without itervetio, oly the followig two variables still demostrated sigificat group differeces. The IG deteriorated while the CG was almost stable regardig social ad cogitive fuctio (FIM r). However, for trasfers (COVS), the IG deteriorated sigificatly less tha the CG. I the CG, a sigificat decrease i balace, trasfers ad ADL, physical fuctios, was demostrated from baselie to the 6-moth follow-up. I a RCT by Rosedahl et al. [15], the FOPANU study, a high-itesity fuctioal exercise program for ursig home residets over a period of 3 moths resulted i improved self-paced gait speed i their IG compared to the CG. At 6 moths, sigificat improvemets i favor of the exercise group were obtaied i BBS, self-paced gait speed ad lower limb stregth [15]. This is i cotrast to our results, where, withi the IG, fuctioal leg muscle stregth improved after 3 moths but deteriorated after aother 3 moths. However, the desig of the FOPANU study icluded cotiuous ecouragemet of the participats to go o with their physical traiig for aother 3 moths after the itervetio period, which could explai their positive log-term effects. I our study, the withdrawal of the itervetio measures might have led to disappoitmet for some of the IG participats. Those who had ejoyed itesified activity could have bee egatively iflueced ad therefore lost iterest ad become iactive. Ecouragemet ad stimulatio to be physically active is of great importace, ad access to rehabilitatio staff seems crucial to achieve improvemets i fuctio amog ursig home residets. These residets form a frail group ad are ofte uable to carry out physical traiig o their ow. I order to maitai positive results, physical traiig should be a costatly ogoig activity. As older people form a heterogeeous group, itervetio programs should focus o persoal skills ad self-cofidece. Goals should be as realistic as possible ad aim at improvig activity ad idepedece [39]. The fact that the more cogitively itact idividuals dropped out after baselie is iterestig. The explaatio Frädi et al.

7 Table 3. Differeces withi the IG ( = 129): aalysis per protocol ad ITT Outcome variables Aalysis per protocol Aalysis of ITT baselie, media (rage) 6-moth follow-up, media (rage) (T1 T3) baselie, media (rage) 6-moth follow-up, media (rage) (T1 T3) FIM items a m (13 90) 45 (13 91) (13 90) 45 (13 91) 0.11 FIM items r (5 35) 22 (6 35) (5 35) 22 (6 35) BBS (0 56) 16 (0 55) (0 56) 13 (0 55) 0.07 NHLSD semi-total (4 50) 22 (0 50) (0 50) 20 (0 50) 0.09 NHLSD total (5 100) 33 (0 100) (5 100) 30 (0 100) 0.23 COVS (15 91) 60 (14 91) (15 91) 60 (14 91) 0.94 Walkig/wheelchair propulsio Self-selected speed, m/s ( ) 0.48 ( ) ( ) 0.45 ( ) 0.30 Maximum speed, m/s ( ) 0.67 ( ) ( ) 0.67 ( ) 0.18 The Timed Chair Stad Test, s (8 219) 28.5 (8 216) (8 219) 30 (8 216) 0.94 FES(S) (0 130) 84 (0 130) (0 130) 83.5 (0 130) 0.22 PGCMS (2 17) 11 (1 17) (2 17) 11 (1 17) 0.16 MMSE (0 29) 18 (0 30) (0 29) 19 (0 30) 0.41 High scores o PGCMS idicate higher level of well-beig; a high score o MMSE idicates a better cogitive fuctio; a high score o FIM or COVS idicates a high degree of idepedece i ADL; a high score o the BBS idicates a better balace fuctio; a high score o the NHLSD idicates a high physical activity level ad more idepedece i mobility; a high score o FES(S) idicates a high degree of fall-related self- efficacy. NHLSD semi-total = Extesio of physical activity; NHLSD total = extesio ad depedecy i physical activity. 1 Wilcoxo siged rak test, sigificace level Table 4. Differeces withi the CG ( = 112): aalysis per protocol ad ITT Outcome variables Aalysis per protocol Aalysis of itetio to treat baselie, media (rage) 6-moth follow-up, media (rage) (T1 T3) baselie, media (rage) 6-moths follow-up, media (rage) (T1 T3) FIM items a m (13 91) 39 (13 91) (13 91) 39 (13 91) 0.02 FIM items r (5 35) 22.5 (5 35) (5 35) 23 (5 35) 0.95 BBS (0 54) 17 (0 52) (0 54) 16 (0 52) 0.01 NHLSD semi-total (0 50) 23 (0 50) (0 50) 22 (0 50) 0.07 NHLSD total (0 100) 36 (0 100) (0 100) 30.5 (0 100) 0.21 COVS (13 91) 60 (13 91) (13 91) 55 (13 91) Walkig/wheelchair propulsio Self-selected speed, m/s ( ) 0.40 ( ) ( ) 0.40 ( ) 0.76 Maximum speed, m/s ( ) 0.56 ( ) ( ) 0.56 ( ) 0.25 The Timed Chair Stad Test, s (8 187) 25 (8 73) (8 187) 27 (8 73) 0.96 FES(S) (0 130) 75 (0 130) (0 130) 75 (0 130) 0.40 PGCMS (0 17) 10 (1 17) (0 17) 10 (1 17) 0.81 MMSE (0 30) 20 (0 30) (0 30) 19 (0 30) 0.62 High scores o PGCMS idicate a higher level of well-beig; a high score o MMSE idicates a better cogitive fuctio; a high score o FIM or COVS idicates a high degree of idepedece i ADL; a high score o the BBS idicates a better balace fuctio; a high score o the NHLSD idicates a high physical activity level ad more idepedece i mobility; a high score o FES(S) idicates a high degree of fall-related self- efficacy. NHLSD semi-total = Extesio of physical activity; NHLSD total = extesio ad depedecy i physical activity. 1 Wilcoxo siged rak test, sigificace level for this might be that they were more likely to itetioally stop participatig because they still had the ability to do so, while those residets who were severely cogitively impaired were likely to be icapable of makig such a resolute decisio. Those who dropped out after the itervetio period had completed fewer itervetio weeks Idividually Tailored Physical Traiig i Nursig Homes tha the others ad were i may cases exposed to illess ad had to be admitted to hospital i case of emergecy. I the preset study, o sigificat differeces betwee the groups could be demostrated regardig wellbeig. It could be the case that well-beig i this group does ot chage i such a short time as 3 or 6 moths, or 7

8 that a more comprehesive itervetio is eeded. Few exercise studies have bee performed with the aim of ifluecig depressive symptoms ad well-beig i ursig home residets with a high prevalece of physical ad cogitive impairmets, ad the results are icosistet [40, 41]. Most existig studies have excluded people who were uable to walk or people with severe cogitive impairmets [40]. Accordig to a systematic review i 2010, it is possible to modify metal well-beig i later life through exercise ad physical activity, but more kowledge is eeded regardig the log-term effects o wellbeig [7]. A study by Chi et al. [41] demostrated that either stregth traiig or all-roud, fuctioal traiig of moderate itesity is effective i improvig quality of life, vitality or depressio of older people livig i logterm care facilities. However, their traiig was performed oly twice a week ad ot for 30 mi a day, as recommeded for older adults [42]. Neither could the FOPANU study show ay impact o well-beig i older ursig home residets [40]. A sigificat differece betwee the groups regardig the mea chage score i the FIM subscale Social ad Cogitive Fuctio was demostrated, i.e. the IG deteriorated while the CG was stable. As the evaluatio was doe by the ursig home staff workig close to the residets, the disappoitmet for some of the IG participats after cessatio of the itervetio might be reflected i worse scores o the social subscale. The absece of chage show i MMSE cotradicts this fidig as both groups maitaied ad eve slightly icreased their cogitive fuctio over the 6-moth period. Oe explaatio for this cotradictio could be that FIM items r also iclude other areas tha cogitio, such as commuicatio ability ad social iteractio [20], ad therefore do ot measure exactly the same cocept. I a recetly preseted RCT [43], improvemet ad maiteace of cogitive fuctios ad a reductio i the risk of cogitive declie i elderly persos at risk selected from the geeral populatio were demostrated. Their multidomai itervetio (diet, exercise, cogitive traiig, vascular risk moitorig) lasted for 2 years, idicatig that a cosiderably loger itervetio time tha 3 moths is eeded for positive effects o cogitive fuctios. There are some limitatios i the preset study. The iclusio of such frail persos as ursig home residets i a study ofte affects the rate of compliace egatively ad makes it difficult to draw coclusios cocerig itervetio effects over time. The extra Daish exclusio criterio of participats with MMSE scores lower tha 17 could i some way have iflueced the cogitive ad 8 physical coditio of the study group. However, the Daish group represeted oly 16% of the whole study group, so we judged the impact to be limited. Aalysis of the results at baselie showed o ifluece besides age differeces regardig legth of stay ad FES I-ADL [18]. The stregths of the study are factors such as blidig of testers, radomizatio ad aalysis by ITT ad per protocol, but also its desig as a multiceter study. We chose to perform the ITT aalyses by the last value carried forward as the imputig method. It is a commo method that is recommeded for this type of data [38]. We made the assumptio that the results from those who dropped out would ot chage over time. This could have meat that the results show for the participats i the IG were too low, while those for the participats i the CG were too high, so that differeces betwee the groups could ot be detected. The frequecy of traiig sessios (5 days/ week) ad the log period of itervetio (12 weeks) also stregtheed the study. However, from a lifespa perspective, 3 moths of itervetio is a short period. Physical traiig should be a regular ad cotiuous activity throughout life, also i ursig home residets, which is clearly supported by the results from this study. Future research should focus o effects of a ogoig itervetio, similar to the setup practiced i this study, repeatedly adjusted to the wishes ad status of the ursig home residets. Coclusio Our study has demostrated that the effects of 3 moths of idividually tailored itervetio drop back to almost baselie level after 3 moths of detraiig. This strogly stresses the importace of cotiuous physical exercise adjusted to the fuctioal level ad eeds of each residet ad supported by rehabilitatio staff. This approach is crucial for the maiteace of the best possible physical fuctio i these vulerable elderly persos. Ackowledgemets The authors warmly thak Valter Sudh for ivaluable statistical advice. We also sicerely thak the residets i the 3 coutries who coseted to take part i the study, ad all staff who plaed ad carried out the itervetio measures. This work was supported by the Natioal Society for Research o Agig, the Swedish Research Coucil, the Cetre for Carig Scieces at Karoliska Istitutet, the Swedish Order of St. Joh; Kig Gustaf V s ad Quee Victoria s Foudatio, Ageig ad Health, Stockholms Sjukhem Foudatio, the Norwegia Cetre Frädi et al.

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