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Exercise intervention and health checks for middle-aged men with elevated cardiovascular risk: A randomized controlled trial

Liira, Helena,Enberg, Elina,Leppävuori, Jenni,From, Svetlana,Kautiainen, Hannu,Liira, Juha,Remes-Lyly, Taina,Tikkanen, Heikki,Pitkälä, Kaisu

Abstract

OBJECTIVE: To study the effects of a health check by a nurse alone or combined with an exercise intervention in middle-aged men at increased cardiovascular risk. DESIGN: A randomized controlled trial. SETTING AND INTERVENTION: Primary care in Kirkkonummi municipality with 36 000 inhabitants. A health check by a nurse alone or combined with an exercise intervention to controls with no intervention was compared. SUBJECTS: A total of 168 men aged 35 to 45 years with at least two cardiovascular risk factors and physical activity (PA) frequency < 3 times a week. MAIN OUTCOME MEASURES: Metabolic syndrome (MetS) as defined by International Diabetes Federation/American Heart Association and self-reported PA frequency. RESULTS: Overall, focusing on health increased physical activity frequency in middle-aged men. After one year, 19% had increased PA to ≥ 3 times a week (95% CI 12-26). All study groups increased PA to ≥ 3 times: 26% of men in the exercise intervention group, 15% of men in the health check group, and 16% of controls. The differences between the groups were not statistically significant. The intervention did not have any meaningful impact on MetS or other cardiovascular outcomes at one-year follow up. CONCLUSIONS: Physical activity increased in all study groups of middle-aged men in this health-promotion trial. The interventions had no effect on metabolic syndrome or other cardiovascular outcomes in the participants. The trial increased awareness and collaboration in physical activity promotion among municipal health care and exercise

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Full Te ms & Condi ions o access and use can be ound a h p://www. and online.com/ac ion/jou nalIn o ma ion?jou nalCode=ip i20 Download by: [Tampe e Uni e si y] Da e: 24 No embe 2016, A : 05:07 Scandina ian Jou nal o P ima y Heal h Ca e ISSN: 0281-3432 (P in ) 1502-7724 (Online) Jou nal homepage: h p://www. and online.com/loi/ip i20 Exe cise in e en ion and heal h checks o middle-aged men wi h ele a ed ca dio ascula isk: A andomized con olled ial Helena Lii a, Elina Engbe g, Jenni Leppä uo i, S e lana F om, Hannu Kau iainen, Juha Lii a, Taina Remes-Lyly, Heikki Tikkanen & Kaisu Pi kälä To ci e his a icle: Helena Lii a, Elina Engbe g, Jenni Leppä uo i, S e lana F om, Hannu Kau iainen, Juha Lii a, Taina Remes-Lyly, Heikki Tikkanen & Kaisu Pi kälä (2014) Exe cise in e en ion and heal h checks o middle-aged men wi h ele a ed ca dio ascula isk: A andomized con olled ial, Scandina ian Jou nal o P ima y Heal h Ca e, 32:4, 156-162, DOI: 10.3109/02813432.2014.984967 To link o his a icle: h p://dx.doi.o g/10.3109/02813432.2014.984967 © 2014 The Au ho (s) Published online: 01 Dec 2014. Submi you a icle o his jou nal A icle iews: 483 View ela ed a icles View C ossma k da a Ci ing a icles: 1 View ci ing a icles Scandina ian Jou nal o P ima y Heal h Ca e, 2014; 32: 156–162 ISSN 0281-3432 p in /ISSN 1502-7724 online © 2014 The Au ho (s) DOI: 10.3109/02813432.2014.984967 ORIGINAL ARTICLE Exe cise in e en ion and heal h checks o middle-aged men wi h ele a ed ca dio ascula isk: A andomized con olled ial HELENA LIIRA 1,4 , ELINA ENGBERG 2,3 , JENNI LEPP Ä VUORI 2,3 , SVETLANA FROM 4 , HANNU KAUTIAINEN 5 , JUHA LIIRA 6 , TAINA REMES-LYLY 7 , HEIKKI TIKKANEN 2,3 & KAISU PITK Ä L Ä 4 1 Depa men o Gene al P ac ice, School o Medicine, Uni e si y o Tampe e, 2 Depa men o Spo s and Exe cise Medicine, Ins i u e o Clinical Medicine, Uni e si y o Helsinki, 3 Founda ion o Spo s and Exe cise Medicine, Clinic o Spo s and Exe cise Medicine, Helsinki, 4 Uni o P ima y Heal h Ca e, Helsinki Uni e si y Cen al Hospi al and Depa men o Gene al P ac ice, Uni e si y o Helsinki, 5 Medca e Founda ion, Ä ä nekoski, 6 Finnish Ins i u e o Occupa ional Heal h, Helsinki, and 7 Ki kkonummi Heal h Cen e Abs ac Objec i e. To s udy he e ec s o a heal h check by a nu se alone o combined wi h an exe cise in e en ion in middle-aged men a inc eased ca dio ascula isk. Design. A andomized con olled ial. Se ing and in e en ion. P ima y ca e in Ki k- konummi municipali y wi h 36 000 inhabi an s. A heal h check by a nu se alone o combined wi h an exe cise in e en ion o con ols wi h no in e en ion was compa ed. Subjec s. A o al o 168 men aged 35 o 45 yea s wi h a leas wo ca dio- ascula isk ac o s and physical ac i i y (PA) equency ⬍ 3 imes a week. Main ou come measu es. Me abolic synd ome (Me S) as de i ned by In e na ional Diabe es Fede a ion/Ame ican Hea Associa ion and sel - epo ed PA equency. Resul s. O e all, ocusing on heal h inc eased physical ac i i y equency in middle-aged men. A e one yea , 19% had inc eased PA o ⱖ 3 imes a week (95% CI 12 – 26). All s udy g oups inc eased PA o ⱖ 3 imes: 26% o men in he exe cise in e en- ion g oup, 15% o men in he heal h check g oup, and 16% o con ols. The di e ences be ween he g oups we e no s a is ically signi i can . The in e en ion did no ha e any meaning ul impac on Me S o o he ca dio ascula ou comes a one-yea ollow up. Conclusions. Physical ac i i y inc eased in all s udy g oups o middle-aged men in his heal h-p omo ion ial. The in e en ions had no e ec on me abolic synd ome o o he ca dio ascula ou comes in he pa icipan s. The ial inc eased awa eness and collabo a ion in physical ac i i y p omo ion among municipal heal h ca e and exe cise se ices. Key Wo ds: Ca dio ascula isk , exe cise in e en ion , Finland , gene al p ac ice , heal h check , me abolic synd ome wi h die a y changes, i dec eases he incidence o ype 2 diabe es melli us in high- isk g oups [3], imp o es he Me S in gene al [4], and educes HbA1c le els in pa ien s wi h ype 2 diabe es [5]. The challenge is ha people do no adhe e o PA ecom- menda ions. The main easons o his in he middle- aged include economic ac o s, lack o ime, and low mo i a ion [6]. Al hough he e ec i eness o such in e en ions on mo bidi y may now be ques ionable [7], he e was a end in Finland o conduc heal h checks o 40-yea -old men o imp o e hei li es yle habi s. Also in Ki kkonummi municipali y, he heal h ca e In oduc ion Middle-aged men s a o p esen symp oms o me - abolic synd ome (Me S), which makes hem a ele- an a ge o heal h p omo ion. In Finland, he No h Ka elia p ojec ocused mos ly on nu i ion and se es as a model o an e ec i e heal h-p omo- ion in e en ion o educe ca dio ascula isk [1]. Nowadays, a seden a y li es yle has become p e a- len and i appea s ha inc easing physical ac i i y (PA) may be one o he mos e ec i e means o con- ol ca dio ascula isk. The posi i e e ec s o PA a e well s udied: i p o- mo es weigh loss [2], especially when combined Co espondence: Helena Lii a, Kuninkaan ie 4, 02400 Ki kkonummi, Finland. E-mail: [email p o ec ed] This is an Open Access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion-Non-Comme cial License (h p://c ea i ecommons.o g/licenses/by-nc/3.0) (Recei ed 9 Ap il 2014 ; accep ed 10 Oc obe 2014 ) Heal h checks and exe cise in e en ion o men wi h ca dio ascula isk 157 policy-make s wan ed o commence a p og amme o heal h checks. Howe e , in addi ion o heal h checks we we e able o s a a andomized con olled ial s udying he e ec i eness o heal h checks alone o in combina ion wi h an exe cise in e en ion. Because an indi idual app oach may no be su - i cien o li es yle changes, we added a g oup-based exe cise in e en ion o he ial. This was especially impo an as Ki kkonummi is a commu e own in he Helsinki a ea whe e mos inhabi an s mo e o wo k in he capi al egion and as a esul o his men end up lacking hei na u al g oups o pee s o exe - cise. The e o e, as one o he communi y a ge s wi h his ial we aimed o es ablish g oups o men exe cis- ing oge he . We also wan ed o c ea e coope a ion be ween he heal h cen e and o he municipal ac i - i ies, such as adul educa ion and exe cise se ices in heal h p omo ion. Al hough he e is e idence o he e ec s o exe - cise plus die in indi iduals al eady p esen ing wi h impai ed glucose ole ance [3] and o he clinical mani es a ions [4,5], he e is s ill a need o s udies on exe cise alone in p ima y heal h ca e a ge ed a isk g oups. Ou aim was o a ge he isk g oup o middle-aged men wi h ca dio ascula isk ac o s wi h wo in e en ions: heal h checks and an exe cise in e en ion, and o s udy he e ec s in a andomized con olled ial. In his pape , we p esen he i ndings o he ial wi h ega d o i s main ou comes: me a- bolic synd ome and physical ac i i y. Ma e ial and me hods Gene al design We planned a h ee-a med one-cen e andomized con olled ial (see Figu e 1). The me hods ha e been desc ibed in de ail ea lie [8]. Men we e ec ui ed by h ee me hods: by in i a ion le e s o 40-yea -olds, by mass media and local campaigning, and by a ge ed ec ui ing in he heal h se ices. A e sc eening and andomiza ion, he i s s udy a m ecei ed a 1 ½ -hou heal h check in e en ion by a public heal h nu se. The second in e en ion a m ecei ed, in addi ion o he heal h check, a guided g oup exe cise in e en ion o 12 weeks. The hi d g oup se ed as a con ol g oup, and men in his g oup had he oppo uni y o pa icipa e in he heal h checks and exe cise in e en ions a e one yea . Pa icipan s Inclusion c i e ia we e p ede i ned as ollows: men aged 35 o 45 wi h a leas wo ca dio ascula isk ac o s. These included BMI 27 – 34 kg/m 2 , wais ci - cum e ence ⬎ 94 cm, as ing glucose ⬎ 6.1 mmol/l, o al plasma choles e ol ⬎ 5.0 mmol/l, LDL-choles- e ol ⬎ 3.0 mmol/l, iglyce ides ⬎ 2.0 mmol/l, sys- olic blood p essu e ⬎ 140 mmHg, dias olic blood p essu e ⬎ 90 mmHg and cu en ly ei he smoking o on choles e ol-lowe ing o blood p essu e-lowe - ing medica ion. Exclusion c i e ia we e as ollows: BMI o e 34 (o any o he physical ba ie p e en ing pa icipa- ion in he exe cise in e en ion) o ac i e exe cise (exe cising o a leas 30 minu es h ee imes a week o mo e) o ha ing an immedia e heal h p oblem equi ing ea men o a se e e isk ac o , o exam- ple, ecen ly diagnosed o uncon olled ype I diabe- es, o symp oma ic co ona y a e y disease. Randomiza ion Once he men had consen ed o pa icipa e in he s udy and he baseline measu emen s we e ca ied ou , hey we e andomly alloca ed o one o he h ee s udy g oups. A andomiza ion lis based on andom num- be s was made and ans e ed o sequen ially num- be ed, sealed en elopes. The s udy coo dina o (SF) opened he en elopes in numbe ed o de and in o med pa icipan s o hei s udy a m and p ocedu es. S udy in e en ions Heal h check in e en ion by a nu se . Public heal h nu ses used s anda d p ac ices in hei heal h-p o- mo ion in e en ion. P io o he onse o he ial, hey a ended a aining session a anged by he Finnish Hea Associa ion. In hei in e en ions, he nu ses used he ype 2 diabe es disease isk assessmen o m (Finnish Diabe es Associa ion) [9], and he ca dio ascula isk assessmen cha ( he Finnish Hea Associa ion). The in e en ion I is known ha p omo ion o physical ac i i y in p ima y ca e o seden a y adul s leads o a small o medium imp o emen in sel - epo ed physi- cal ac i i y a 12 mon hs. A 19% inc ease was obse ed a one yea in • o e all sel - epo ed physical ac i i y in mid- dle-aged men who pa icipa ed in a heal h- p omo ion ial. The change in physical ac i i y did no ha e • an e ec on he heal h ou comes a one-yea ollow-up. The ial had communi y e ec s: g oups o • men con inued exe cising oge he and he ial inc eased collabo a ion be ween heal h and exe cise se ices in he municipali y. 158 H. Lii a e al. included assessmen s o indi idual isks, die a y habi s, PA, and a mo i a ional alk abou hese hab- i s. The in e en ion las ed up o 90 minu es and did no include a ollow-up. Exe cise in e en ion. In addi ion o he heal h checks, he second in e en ion g oup was also in i ed o a g oup exe cise in e en ion. The size o hese g oups a ied om 10 o 20 people. The exe cise in e en- ion g oup me once a week and was guided by a physical educa ion counsello and consis ed o a i- ous ypes o basic physical aining. The exe cise ses- sions las ed 60 minu es each. Du ing he 12 weekly mee ings se e al sa e exe cise ac i i ies o a leas mode a e in ensi y we e in oduced, such as No dic walking, i ness ci cle, olleyball, swimming, ci cui aining, gym, boxing, zumba, e c. In addi ion o he s udy in e en ions, all g oups ecei ed, i necessa y, s anda d ea men a Ki kkon- ummi Heal h Cen e, a municipal public p ima y ca e uni . I a pa icipan showed any need o medical ea men , o his medica ions equi ed medical a en- ion, he was e e ed o a p ima y ca e physician. Ou come measu es The ou comes we e measu ed a e h ee and 12 mon hs o he andomiza ion. The blood es s we e aken a mon hs 0, 3, and 12. O he ou comes we e measu ed by In e ne su eys and, i he pa icipan did no espond, by elephone su eys. We had wo p ima y ou come measu es. Fi s , Me S as de i ned by he In e na ional Diabe es Fede a ion/Ame ican Hea Associa ion [10], i.e. 436 eligible o labo a o y es ing and isk assessmen A = Heal h check by a nu se n = 60 168 men ga e consen and we e andomized B = Exe cise in e en ion and heal hcheck n = 54 C = Con ols n = 54 665 men sc eened Excluded: 39 wi h BMI >34 190 exe cised a leas 3 imes e week 3 mon h ollow up n = 47 3 mon h ollow up n = 32 3 mon h ollow up n = 46 12 mon h ollow up n = 42 12 mon h ollow up n = 46 12 mon h ollow up n = 43 Figu e 1. Pa icipan l ow diag am. Heal h checks and exe cise in e en ion o men wi h ca dio ascula isk 159 checking whe he h ee o mo e o he ollowing c i- e ia we e ul i lled: (i) sys olic blood p essu e ⱖ 130 o dias olic blood p essu e ⱖ 85 o speci i c medica- ion; (ii) iglyce ides ⱖ 1.7 mmol/L o speci i c medica ion; (iii) HDL choles e ol ⬍ 1.0 mmol/L o speci i c medica ion; (i ) as ing plasma glucose ⱖ 5.6 mmol/L o speci i c medica ion; o ( ) wais ci cum e ence ⬎ 94 cm. We chose me abolic syn- d ome as ou main ou come measu e as we expec ed ha in his g oup o men wi h ele a ed ca dio ascu- la isk i could be modi i ed by ou in e en ions. The second p ima y ou come measu e was sel - epo ed PA assessed by asking how many imes pe week a pa icipan pe o med any exe cise ha induced swea ing and go he pe son a leas sligh ly ou o b ea h, i.e. was a leas o mode a e in ensi y, o a leas 30 minu es. S a is ical analyses The esul s a e exp essed as p opo ions o means and s anda d de ia ions (SD). S a is ical compa i- sons be ween he g oups wi h con inuous a iables in baseline cha ac e is ics we e pe o med using analysis o a iance o he K uskall-Wallis es and wi h a chi-squa ed es o Fishe ’ s exac es o dicho omous a iables. The di e ences be ween g oups in PA and Me S we e es ed by using boo - s ap echniques. Boo s apping is a e-sampling me hod, in which no assump ions on dis ibu ion a e made [11]. The α -le el was se a 0.05. All s a is ical analyses we e pe o med using STATA ( o Windows), e sion 10 (S a a Co p, College S a- ion, TX, USA). Resul s Th ee age coho s we e in i ed o he s udy, he 1969 bo n (n ⫽ 313 and 122 esponded), he 1970 bo n (n ⫽ 330 and 110 esponded), and he 1971 bo n (n ⫽ 303 and 88 esponded). O e all, 320 o 946 in i ed men (34%) esponded and pa icipa ed in he sc eening. An addi ional 345 men became in e es ed in he ial ia he mass media, campaigning, o a - ge ed in i a ions. Be ween 2009 and 2011, a o al o 665 men aged be ween 35 and 45 yea s esponded o he sc eening ques ionnai e o he ial. The pa - icipan l ow diag am is p esen ed in Figu e 1. A e labo a o y es ing and isk assessmen , al oge he 168 men consen ed and we e andomized in o he ial. The baseline cha ac e is ics o he men a e p e- sen ed in Table I. Physical ac i i y O e all, he men in he ial inc eased hei PA e- quency. Since men who exe cised a leas h ee imes pe week we e excluded om he ial, none o he pa icipan s exe cised h ee imes pe week a baseline. All s udy g oups inc eased hei PA (Figu e 2), and o all pa icipan s, 19% (95% CI 12 – 26) con inued Table I. Baseline pa icipan cha ac e is ics: mean (and s anda d de ia ion). All (n ⫽ 168) Heal h check (n ⫽ 60) Exe cise in e en ion (n ⫽ 54) Con ols (n ⫽ 54) P 1 Mean age, yea s (SD) 40.3 (2.9) 40.2 (2.5) 40.4 (2.8) 40.3 (3.5) 0.95 (NS) Weigh , kg (SD) 88.4 (11.9) 89.3 (12.9) 89.6 (11.1) 86.2 (11.4) 0.26 (NS) Heigh , cm (SD) 180.8 (6.4) 181.3 (6.6) 180.5 (6.3) 180.7 (6.2) 0.79 (NS) Wais ci cum e ence, cm (SD) 99 (13.4) 99 (11.6) 101 (18.0) 98 (10.2) 0.55 (NS) Sys olic blood p essu e, mmHg (SD) 134 (12.9) 132 (14.3) 135 (10.2) 136 (13.9) 0.28 (NS) Dias olic blood p essu e, mmHg (SD) 84 (9.0) 82 (9.5) 86 (7.6) 84 (9.7) 0.09 (NS) RR medica ion (%) 8 3 11 9 0.27 (NS) Glucose, mmol/l (SD) 5.7 (0.7) 5.8 (0.9) 5.7 (0.6) 5.6 (0.4) 0.67 (NS) Choles e ol, mmol/l (SD) 5.4 (0.8) 5.5 (0.8) 5.3 (0.8) 5.2 (0.8) 0.05 (NS) LDL, mmol/l (SD) 3.6 (0.7) 3.7 (0.7) 3.5 (0.7) 3.5 (0.7) 0.10 (NS) HDL, mmol/l (SD) 1.4 (0.4) 1.3 (0.4) 1.4 (0.4) 1.4 (0.3) 0.90 (NS) T iglyce ides, mmol/l (SD) 1.4 (0.7) 1.6 (0.9) 1.4 (0.7) 1.2 (0.5) 0.01 ( * ) Me abolic synd ome, n (%) 45 (7) 59 (13) 42 (13) 35 (13) 0.03 ( * ) F equency o physical ac i i y (a leas mode a e in ensi y, ⱖ 30 minu es), n (%) 2 Some imes o ne e 1 – 2 imes/week 58 (35) 110 (65) 21 (35) 39 (65) 21 (31) 33 (69) 16 (40) 38 (60) 0.07 (NS) No es: 1 S a is ical compa isons be ween he g oups we e pe o med using analysis o a iance o K uskall – Wallis es o con inuous a iables and chi-squa ed es o Fishe ’ s exac es o ca ego ical a iables. 2 The men who exe cised ⱖ 3 imes/week we e excluded om he ial and he e o e no one exe cised his much a baseline. 160 H. Lii a e al. exe cising a leas h ee imes a week a 12 mon hs. In he exe cise in e en ion g oup, 26% (95% CI 11 – 40) o men pu sued exe cising a leas h ee imes a week, in he heal h check g oup 16% (95% CI 5 – 27) and in he con ol g oup 17% (95% CI 5 – 29); howe e he di e ences be ween he g oups we e no s a is ically signi i can (Figu e 2). Me abolic synd ome A baseline, 45% o men ul i lled he c i e ia o Me S. Al hough he e was a end owa ds a dec eased p opo ion o men wi h Me S a h ee mon hs, a e 12 mon hs he p e alence o Me S had e u ned o he o iginal le el o abo e (Figu e 3). The e we e no di e ences be ween he in e en ion g oups and he con ol g oup in he p e alence o Me S. O he ou comes The ca dio ascula ou comes a e p esen ed in Table II. The in e en ions had no s a is ically sig- ni i can e ec s on hese ou comes a h ee mon hs o a 12 mon hs. Discussion Ou p agma ic ial o an exe cise in e en ion and heal h checks in a municipal heal h cen e was able o change he exe cise habi s o middle-aged men in all s udy g oups. We ec ui ed men wi h a leas wo ca dio ascula isk ac o s and low le els o PA. A e one yea , 19% o hese seden a y men had inc eased hei PA equency o a leas h ee imes a week. The e we e no di e ences be ween he s udy g oups in PA. Ou esul s a e simila o p e ious s udies on heal h p omo ion in p ima y ca e. A sys ema ic e iew published in 2012 [12] obse ed small e ec s wi h physical ac i i y p omo ion o pa ien s ec ui ed in p ima y ca e. I p o ided an es ima ion o a numbe needed o ea (NNT) o 12, which means ha 12 pa ien s need o be a ge ed wi h physical ac i i y p omo ion o one o become ac i e. This can be compa ed wi h smoking cessa- ion ad ice, whe e NNTs o 50 o 120 ha e been epo ed [13]. Al hough men inc eased he equency o exe cise, we ound no e ec s on heal h ou comes, me abolic synd ome, o indi idual ca dio ascula ou comes. Fo subs an ial heal h bene i s, adul s should do a leas 150 minu es a week o mode a e in ensi y, o 75 min- u es a week o igo ous-in ensi y ae obic physical ac i i y, o an equi alen combina ion o hese [14,15]. Ou ou come measu e, sel - epo ed physical ac i i y, is somewha c ude and does no ake in o accoun he in ensi y o he exe cise o he po en ial exe cise du - ing wo king hou s. Howe e , in a p agma ic p ima y heal h ca e ial i was he mos easible me hod. Time, mon hs 312 Physical ac i i y ≥3 imes pe week, % 0 6 12 18 24 30 36 42 48 54 60 Heal h Exe cise Con ol p=0.51 p=0.42 Key: Heal h = heal h check. Exe cise = exe cise in e en ion and heal h check. Figu e 2. Pe cen age o men who pe o med physical ac i i y a leas h ee imes a week a h ee and 12 mon hs in s udy g oups. Time, mon hs 03 12 Pe cen age o Me S 0 10 20 30 40 50 60 70 80 90 100 p=0.013 p=0.19 p=0.33 Heal h Exe cise Con ol Key: Me S = me abolic synd ome. Heal h = heal h check. Exe cise = exe cise in e en ion and heal h check. Figu e 3. Pe cen age o men wi h 95% con i dence in e als wi h me abolic synd ome a h ee and 12 mon hs in s udy g oups. Heal h checks and exe cise in e en ion o men wi h ca dio ascula isk 161 The changes in exe cise habi s did no ha e e ec s on he p e alence o me abolic synd ome in he pa icipan s. Ei he he change in ac i i y was no la ge enough, he ollow-up was no long enough o obse e he e ec s, o o he li es yle changes such as die ing would ha e been equi ed. I also appea s ha me abolic synd ome is di i cul o al e and may no be an op imal ou come measu e. The choice o he ou come measu es mus be conside ed as a lim- i a ion o his ial. Randomized con olled ials a e no commonly conduc ed in p ima y ca e in Finland. This e o augh us se e al lessons. Using mass media and local campaigning was e ec i e o ec ui men bu i also con amina ed he ial as he p ojec was e y isible in he local newspape and e en s, which led o he con ol men also ecei ing some o he in e en ion. The weakness o ou s udy is ha i lacks powe . I was designed o 300 men, and we we e able o ec ui and andomize only 168 men. Al hough he ial ecei ed much a en ion in he communi y and men eage ly ook pa in he sc eening su ey, i was di i cul o mo i a e hem o a end o labo a o y es ing and o pa icipa e in he ollow-up. Middle-aged men li e busy li es wi h wo k and amilies and i is challenging o hem o commi hemsel es o a weekly in e en ion. Acco ding o he g oup counsello s, he pa icipa ion a es in he exe cise g oups a ied be ween 50% and 80%. Pa icipan s in he con ol g oup we e in i ed o comple e an online ques ionnai e wi h heal h- and li es yle- ela ed ques ions a baseline and a h ee and 12 mon hs. Fu he mo e, hey we e p omised heal h counselling and g oup exe cise aining a e he 12-mon h s udy pe iod. The ques ionnai es, keeping in con ac wi h he s udy coo dina o , and u u e heal h counselling and exe cise aining may ha e mo i a ed hem o inc ease hei PA. Ou esul s a e consis en wi h p e ious p ima y ca e s udies epo ing inc eases in PA le els also among he con ol g oup. In a Du ch s udy, a ailo ed PA in e en ion inc eased PA le els bu no mo e han in he con ol g oup [16]. I appea ed ha he physical ac i i y measu emen s independen ly a ec ed pa icipan s ’ beha iou [17]. The communi y a ge s in ou s udy we e suc- cess ul. Some men in he exe cise in e en ion g oups con inued exe cising oge he a e he ial, which was one o ou communi y aims. In addi ion, he ial also inc eased collabo a ion be ween he heal h and exe cise se ices in he municipali y. An exe cise counsello s a ed consul a ions a he heal h cen e, and physicians lea n o be e e e hei pa ien s o he municipal exe cise se ices. Since amily medi- cine is no only o indi iduals bu also o communi- Table II. Ca dio ascula ou comes h ee mon hs and 12 mon hs a e he in e en ion: Mean (and s anda d de ia ion). 1. All Heal h check Exe cise in e en ion Con ols Weigh , kg 3 m 12 m 87.3 (11.8) 88.3 (11.8) 90.0 (12.8) 89.6 (11.3) 87.9 (12.1) 89.9 (10.9) 84.7 (10.3) 85.5 (13.0) Sys olic blood p essu e, mmHg (SD) 3 m 12 m 135 (13.0) 136 (11.9) 131 (8.0) 135 (11.8) 138 (14.1) 139 (11.7) 136 (14.8) 134 (12.2) Dias olic blood p essu e, mmHg (SD) 3 m 12 m 83 (8.7) 85 (9.4) 81 (8.3) 83 (10.2) 86 (8.6) 87 (8.2) 80 (9.1) 83 (9.7) Glucose, mmol/l (SD) 3 m 12 m 5.6 (0.6) 5.7 (0.6) 5.5 (0.5) 5.6 (0.6) 5.6 (0.8) 5.7 (0.6) 5.6 (0.5) 5.7 (0.6) Choles e ol, mmol/l (SD) 3 m 12 m 5.2 (0.8) 5.4 (0.9) 5.4 (0.8) 5.5 (0.8) 5.1 (0.9) 5.3 (0.9) 5.1 (0.8) 5.2 (0.8) LDL, mmol/l (SD) 3 m 12 m 3.5 (0.7) 3.5 (0.7) 3.6 (0.7) 3.7 (0.7) 3.4 (0.8) 3.5 (0.8) 3.4 (0.7) 3.4 (0.7) HDL, mmol/l (SD) 3 m 12 m 1.4 (0.3) 1.4 (0.4) 1.3 (0.3) 1.4 (0.3) 1.4 (0.3) 1.4 (0.4) 1.4 (0.3) 1.5 (0.4) T iglyce ides, mmol/l (SD) 3 m 12 m 1.3 (0.6) 1.4 (0.7) 1.4 (0.7) 1.5 (0.8) 1.2 (0.5) 1.4 (0.7) 1.1 (0.4) 1.2 (0.5) No e: 1 Di e ences a e s a is ically non-signi i can . 162 H. Lii a e al. ies, i is impo an o pu he ocus on communi y consequences o ials [18]. In conclusion, ou ial led o small changes in he physical ac i i y o middle-aged men bu we obse ed no changes in ca dio ascula heal h. We we e, howe e , able o inc ease awa eness and col- labo a ion in he municipali y on physical ac i i y heal h p omo ion. E hics app o al The ial was app o ed by he municipal au ho i ies and by he Coo dina ing E hics Commi ee a Helsinki Uni e si y Hospi al on 8 June, 2009 ( e : 4/13/03/00/09). The s udy was egis e ed a Con olled T ials (h p://www.con olled- ials.com). T ial numbe : ISRCTN80672011. Acknowledgemen s The au ho s would like o hank Ms Ma ia Te ä ä inen o help wi h he s udy ma e ial, and he public heal h nu ses ha pe o med he heal h checks as well as he employees a he municipal adul educa ion and exe cise se ices o excellen collabo a ion. Decla a ion o in e es The au ho s epo no con l ic s o in e es . 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