STUDY PROTOCOL Open Access
ICT-based sys em o p edic and p e en alls
(iS oppFalls): s udy p o ocol o an in e na ional
mul icen e andomized con olled ial
Y es J Gschwind
1†
, Sabine Eichbe g
2†
, Hannah R Ma s on
2
, And eas Ejupi
3
, Helios de Rosa io
4
, Michael K oll
2
,
Ma io D obics
3
, Janneke Annega n
5
, Raine Wieching
6
, S ephen R Lo d
1
, Kons an in Aal
6
and Kim Delbae e
1*
Abs ac
Backg ound: Falls a e e y common, especially in adul s aged 65 yea s and olde . Wi hin he cu en in e na ional
Eu opean Commission’s Se en h F amewo k P og am (FP7) p ojec ‘iS oppFalls’an In o ma ion and Communica ion
Technology (ICT) based sys em has been de eloped o egula ly assess a pe son’s isk o alling in hei own home
and o deli e an indi idual and ailo ed home-based exe cise and educa ion p og am o all p e en ion. The
p ima y aims o iS oppFalls a e o assess he easibili y and accep abili y o he in e en ion p og am, and i s
e ec i eness o imp o e balance, muscle s eng h and quali y o li e in olde people.
Me hods/Design: This in e na ional, mul icen e s udy is designed as a single-blinded, wo-g oup andomized
con olled ial. A o al o 160 communi y-dwelling olde people aged 65 yea s and olde will be ec ui ed in
Ge many (n = 60), Spain (n = 40), and Aus alia (n = 60) be ween No embe 2013 and May 2014. Pa icipan s in he
in e en ion g oup will conduc a 16-week exe cise p og am using he iS oppFalls sys em h ough hei ele ision
se a home. Pa icipan s a e encou aged o exe cise o a o al du a ion o 180 minu es pe week. The aining
p og am consis s o a a ie y o balance and s eng h exe cises in he o m o ideo games using exe game
echnology. Educa ional ma e ial abou a heal hy li es yle will be p o ided o each pa icipan . Final eassessmen s
will be conduc ed a e 16 weeks. The assessmen s include physical and cogni i e es s as well as ques ionnai es
assessing heal h, ea o alling, quali y o li e and psychosocial de e minan s. Falls will be ollowed up o six
mon hs by mon hly alls calenda s.
Discussion: We hypo hesize ha he egula use o his newly de eloped ICT-based sys em o all p e en ion a
home is easible o olde people. By using he iS oppFalls senso -based exe cise p og am, olde people a e
expec ed o imp o e in balance and s eng h ou comes. In addi ion, he exe cise aining may ha e a posi i e
impac on quali y o li e by educing he isk o alls. Taken oge he wi h expec ed cogni i e imp o emen s, he
indi idual app oach o he iS oppFalls p og am may p o ide an e ec i e model o all p e en ion in olde people
who p e e o exe cise a home.
T ial egis a ion: Aus alian New Zealand Clinical T ials Regis y T ial ID: ACTRN12614000096651.
In e na ional S anda d Randomised Con olled T ial Numbe : ISRCTN15932647.
Keywo ds: Fall p e en ion, Fall isk assessmen , Olde adul s, Exe cise, S eng h, Balance, Exe games, Video games
* Co espondence: [email p o ec ed]
†
Equal con ibu o s
1
Neu oscience Resea ch Aus alia, Uni e si y o New Sou h Wales, Ba ke
S ee , Randwick, Sydney, New Sou h Wales 2031, Aus alia
Full lis o au ho in o ma ion is a ailable a he end o he a icle
© 2014 Gschwind e al.; licensee BioMed Cen al L d. This is an Open Access a icle dis ibu ed unde he e ms o he C ea i e
Commons A ibu ion License (h p://c ea i ecommons.o g/licenses/by/4.0), which pe mi s un es ic ed use, dis ibu ion, and
ep oduc ion in any medium, p o ided he o iginal wo k is p ope ly c edi ed. The C ea i e Commons Public Domain
Dedica ion wai e (h p://c ea i ecommons.o g/publicdomain/ze o/1.0/) applies o he da a made a ailable in his a icle,
unless o he wise s a ed.
Gschwind e al. BMC Ge ia ics 2014, 14:91
h p://www.biomedcen al.com/1471-2318/14/91
Backg ound
In he nex decades a ise in he p opo ion o people aged
65 yea s and olde is expec ed [1,2]. Success ul independen
li ing in olde people can be comp omised by a numbe o
key heal h condi ions including hea disease, s oke, dia-
be es, and alls [3]. Abou one hi d o communi y-dwelling
olde people alls a leas once a yea [4], inc easing o hal
o people aged 80 yea s and o e [5]. Falls can be de as a -
ing, con ibu ing o a conside able inc ease in mo ali y
and mo bidi y [6]. I is he e o e c ucial o in es in e-
sea ch aimed a dealing wi h heal h challenges o an ageing
popula ion such as all p e en ion. The p e en ion o alls
and i s se ious consequences (e.g., hip ac u e) may enable
olde people o li e independen ly, main ain hei quali y o
li e, and educe heal h ca e cos s [7].
Se e al sys ema ic e iews and me a-analyses ha e p o-
ided obus e idence o suppo in e en ions o p e en -
ing alls in olde people [8,9]. Exe cise in e en ions a e one
o hesinglemos e ec i es a egies o p e en ing alls
[10]. Sys ema ic e iew e idence sugges ha , o be e ec i e
in p e en ing alls, exe cise p og ams mus include a leas
mode a ely-challenging and p og essi e balance exe cises
and be pe o med equen ly (i.e., o mo e han 50 hou s
o e he cou se o he in e en ion pe iod) [10]. Despi e
e idence o he bene i s o exe cising, se e al ba ie s ha e
been iden i ied ha a ec pa icipa ion such as unsui able
schedules o g oup sessions, insu icien means o anspo
o ge o aining acili ies, lack o ime o exe cise due o
o he social commi men s, and eelings o loneliness and
isola ion [11]. Mo e esea ch on al e na i e app oaches o
deli e y o exe cise p og ams is needed o add ess he chal-
lenges and imp o e adhe ence o exe cise p og ams, espe-
cially o olde people and mo e socially dep i ed people
who a e a he highes isk o alling. No el and engaging
me hods ha e g ea po en ial o enhance long- e m mo i -
a ion and adhe ence wi hou inc easing cos s.
The p oposed in e en ion will in es iga e he e ec s o
an indi idually ailo ed ICT-based exe cise p og am deli -
e ed h ough he home ele ision se , called iS oppFalls
(www.is opp alls.eu). The esul s will allow e alua ion o
he in e en ion ega ding easibili y and accep abili y,
quali y o li e, as well as e ec i eness on all isk ac o s in
olde people.
Me hods/Design
Pa icipan s
One hund ed six y communi y-dwelling olde people aged
65 yea s and olde will pa icipa e in his in e na ional,
mul icen e, single-blinded, wo-g oup andomized ial
(Figu e 1). S udy si es a e loca ed in Cologne, Ge many
(n = 60), Valencia, Spain (n = 40), and Sydney, Aus alia
(n = 60). Pa icipan s will be ec ui ed be ween No embe
2013 and May 2014. Olde people will be en olled i hey
mee he ollowing eligibili y c i e ia: (1) aged 65 yea s and
olde , (2) li ing in he communi y, (3) able o walk 20 m
wi hou a walking aid, (4) able o wa ch ele ision (TV)
wi h o wi hou hei glasses om 3 m dis ance, and (5)
ha e enough space o sys em use (3.5 m
2
). The exclusion
c i e ia a e: (1) insu icien language skills o unde s and
he s udy p ocedu es, (2) cogni i e impai men (Mini-
Cog: 1–2 ecalled wo ds and abno mal clock d awing es )
[12], and (3) medical condi ions (i.e., uncon olled hype -
ension, se e e neu ological diso de , acu e cance , psychi-
a ic diso de , acu e in ec ions) ha p e en pa icipa ion
in a egula exe cise p og am. A medical clea ance o m
has o be issued by he pa icipan ’s medical doc o o
con i m medical sui abili y o he in e en ion p og am.
Randomiza ion and blinding
Following success ul baseline assessmen s, pa icipan s will
ecei e a unique compu e -gene a ed andom numbe o
iden i ica ion (ID). A esea ch assis an will hen alloca e
he pa icipan s’ID o he in e en ion o con ol g oup
( a io 1:1) by using pe mu ed block- andomisa ion (so -
wa e a ailable om h ps://apps.neu a.edu.au/blinde s/).
Couples (pa icipan s li ing in he same household) will
be ea ed as one uni and andomised in o he same
block. Reassessmen will be pe o med by expe ienced
and ained esea ch assis an s (RA) who a e blinded o
g oup alloca ion. To a oid unblinding o he RA, pa ic-
ipan s will be eminded no o alk abou hei use ex-
pe ience du ing he eassessmen s.
S udy design
The iS oppFalls sys em consis s o a echnology-suppo ed
all p e en ion p og am and a all isk assessmen . Based
on disc e e measu ing echnologies he sys em p edic s
he indi idual all isk, o e s a ailo ed and a ge ed exe -
cise p og am, and p o ides indi idual eedback o he pa -
icipan . Fo he iS oppFalls p ojec , cus om all p e en ion
so wa e has been de eloped. The iS oppFalls so wa e
pla o m consis s o new ideo game-based exe cises and
exe games ocussing on balance and muscle s eng h, and
a all isk assessmen . A e andomiza ion, he pa ici-
pan s in he in e en ion g oup will be p o ided wi h a
pe sonal compu e (Shu le Ba ebone Slim-PC), a Google
TV se op box (STB) by Sony, a Mic oso Kinec , a
Senio Mobili y Moni o (SMM) by Philips, and a Nexus 7
And oid able .
Resea ch s a will ins all he sys em componen s in
pa icipan s’homes. Du ing he home isi o abou wo
hou s, pa icipan s will ecei e an in oduc o y lesson in
sys em use and an ins uc ion manual. Pa icipan s will
ecei e a ollow-up home isi app oxima ely wo weeks
a e he ins alla ion o ensu e sa e use and p og ession
o aining, and o discuss any issues ela ed o using he
p og am. Addi ional home isi s will be o e ed as needed
o eques ed. The con ol g oup will ollow hei habi ual
Gschwind e al. BMC Ge ia ics 2014, 14:91 Page 2 o 13
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exe cise ou ine. Each pa icipan will be p o ided wi h an
educa ional bookle abou gene al heal h and alls. Pa ici-
pan s will be assessed a baseline (0 weeks), a e 8 weeks,
and a he end o he in e en ion pe iod (16 weeks).
Adhe ence will be moni o ed by he iS oppFalls sys em
which acks he exe cise ac i i y o each pa icipan . Falls
equency will be moni o ed wi h mon hly all dia ies in
con ol and in e en ion pa icipan s o 6 mon hs a e
andomisa ion. A all will be de ined using he in e na ion-
ally de i ed consensus de ini ion o ‘an unexpec ed e en
in which he pa icipan comes o es on he g ound,
loo , o lowe le el’[13]. I he calenda s a e no e u ned,
illed ou inco ec ly, o show non-adhe ence, pa icipan s
will be con ac by phone by a blinded ( alls) and unblinded
(adhe ence) RA, espec i ely. Pa icipan s will ecei e indi-
idual aining eminde s in he middle and he end o
each week ia he iS oppFalls sys em. Addi ionally, pa ici-
pan s will be eminded by an unblinded RA o pe o m a
leas one in e ac i e all isk assessmen (including ques-
ions abou all his o y and sel -adminis e ed physical es s
o balance, eac ion ime, and s eng h) each mon h.
Pa icipan s will be equi ed o gi e w i en in o med
consen p io o inclusion. E hical app o al was ob ained
by he e hics commi ees o he Ge man Spo Uni e si y
Cologne (24.09.2013), he Poly echnic Uni e si y o
Valencia (19.12.2013), and he Human Resea ch E hics
Commi ee o he Uni e si y o New Sou h Wales ( e e -
ence numbe HC12316, 19.12.2013). This ial will be con-
duc ed acco ding o he e hical s anda ds o he Helsinki
Decla a ion.
The iS oppFalls sys em
Pa icipan s in e ac wi h he sys em ia he TV which is
unc ionally ex ended by an and oid-based STB and a cus-
om iS oppFalls applica ion. The STB communica es wi h
he iS oppFalls exe game so wa e ins alled on he PC
(Figu e 2). The applica ion was designed using an exe -
game app oach, and will be used o he exe cises and all
isk assessmen s. The Mic oso Kinec (3D dep h senso )
and he cus om-made SMM (3D accele ome e , ba om-
e e ), which is wo n as a necklace, will moni o he pa ici-
pan ’s pe o mance du ing he assessmen s and exe cises.
In addi ion, he SMM is used o con inuous mobili y
moni o ing (i.e., walking dis ance, si - o-s and ans e pe -
o mance) [14].
Pa icipan s con ol he mo emen s o a i ual a a a
wi h he Mic oso Kinec . The pos u e o he a a a is
de ined by he skele on model o he Kinec So wa e
Ini ial con ac ia phone including p e-
sc eening o eligibili y by a esea ch assis an
Ge many
In e en ion g oup (n = 30)
Con ol g oup (n = 30)
Spain
In e en ion g oup (n = 20)
Con ol g oup (n = 20)
Aus alia
In e en ion g oup (n = 30)
Con ol g oup (n = 30)
Rec ui men by o al p esen a ion, lea le s,
newspape ad e isemen s
In o med consen and baseline assessmen s
16-week iS oppFalls exe cise in e en ion
Assessmen s pos in e en ion
8-week ollow-up wi h alls calenda s
Inclusion and compu e -based andomiza ion
o olde people (n = 180)
Figu e 1 Flow cha o s udy design.
Gschwind e al. BMC Ge ia ics 2014, 14:91 Page 3 o 13
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De elopmen Ki a e applying il e s o a oid je ky
mo emen s [15]. T acked mo ions, join angles, and pos-
u es will be u he used o de ine he eal- ime eed-
back o he use s who will be in o med abou he
dis ance walked (in me e s) equi alen o hei body
mo emen s [16,17]. All agg ega ed da a a e ansmi ed
o a knowledge-based sys em (se e ) o au oma ic da a
analysis and eedback gene a ion. The pa icipan s will
be able o moni o hei esul s con inuously ia he
STB o e hei in e ac i e TV o able a home. An in-
eg a ed social media pla o m will enable use s o in e -
ac wi h each o he and sha e hei esul s.
Design o in e en ion
Following sys em ins alla ion, pa icipan s alloca ed o
he in e en ion g oup will conduc a 16-week exe cise
p og am ocusing on imp o ing s a ic balance, dynamic
balance, and muscle s eng h o he lowe ex emi ies.
The aining con en is based on bes p ac ice ecom-
menda ions o exe cise o p e en alls in olde people
by She ing on e al. [10,18]. I will be ecommended
ha he pa icipan s pe o m a leas h ee balance ses-
sions o abou 40 min each (including each o he exe -
games) and a leas h ee muscle s eng h sessions o
abou 15 o 20 min each (including all s eng h exe -
cises) pe week. Pa icipan s a e ecommended o pe -
o m 10 min o balance exe cises be o e each s eng h
aining session. The weekly aining du a ion should
he e o e o al o abou 120 min o balance aining and
45 o 60 min o s eng h aining ( esul ing in app oxi-
ma ely 50 h o e 16 weeks). Pa icipan s will be e-
commended no o do s eng h aining sessions on
consecu i e days. When balance and s eng h aining is
combined, pa icipan s will be ins uc ed o s a wi h
he balance session. The p esc ibed exe cise in ensi y is
mode a e o high a ying acco ding o he le el o di i-
cul y, numbe o epe i ions, and addi ional ankle cu
weigh s (1 kg o 2 kg) used. Pa icipan s in he in e en-
ion g oup who decide o discon inue he exe cise p o-
g am may s ill con inue o send in he mon hly alls
calenda s and pe o m he eassessmen s.
Gene al aining p inciples
Ashee o ‘Exe cise Sa e y Guidelines’is p o ided o each
in e en ion g oup pa icipan . In o de o maximize
aining e ec and sa e y, pa icipan s a e ad ised o hy-
d a e well be o e, du ing, and a e he exe cise sessions.
They should no exe cise on an emp y s omach o jus
a e a big meal. I is ecommended o pa icipan s o wea
com o able, well- i ed clo hes, and non-slippe y shoes.
Pa icipan s ini ially s a exe cising a an easy le el o be-
come amilia wi h aining and echnology use. Fo sa e y
easons pa icipan s should ha e a chai placed o each
side when exe cising. Pa icipan s a e ad ised o s op
Figu e 2 iS oppFalls ha dwa e sys em componen s. AIT: Aus ian Ins i u e o Technology, DB: da abase, DVB: digi al ideo b oadcas ing, HDMI:
high de ini ion mul imedia in e ace, IR: in a ed, KBS: knowledge based sys em, LAN: local a ea ne wo k, LDB: local da abase, PC: pe sonal
compu e , SMM: Senio Mobili y Moni o , STB: se op box, TV: ele ision, USB: uni e sal se ial bus, USI: Uni e si y o Siegen, WLAN: wi eless local
a ea ne wo k.
Gschwind e al. BMC Ge ia ics 2014, 14:91 Page 4 o 13
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exe cising and immedia ely consul hei doc o i hey eel
unwell (i.e., due o a empo a y illness, no aking hei
egula p esc ibed medica ions, ha ing signs o angina
pec o is; ha ing di icul y b ea hing; and/o eeling dizzy,
ligh headed o ain ).
T aining con en
Balance exe cises
The p inciples o balance exe cises a e based on he O ago
Exe cise P og am [19,20] and he Weigh -bea ing Exe cise
o Be e Balance (WEBB) p og am (www.webb.o g.au).
The iS oppFalls p og am aims o imp o e s a ic balance,
leaning balance and s epping abili y by p ac icing ac i i ies
ele an o ADL. Th ee balance exe games we e speci ic-
ally de eloped o he iS oppFalls p ojec ‘Bumble Bee Pa k’,
‘Hills & Skills’,and‘Balance Bis o’(Figu e 3). All games
a ge mo o skills ela ed o pos u al con ol including
walking, weigh shi ing, knee bending, and/o s epping in
di e en di ec ions. Addi ionally, cogni i e asks a e added
once pa icipan s each highe exe game le els (dual-
asking). In he cogni i e asks, use s ha e o iden i y,
memo ize, and emembe i ems, o pe o m ma hema ical
calcula ions which andomly appea on sc een. P og es-
sion o balance exe games is achie ed by educing uppe
limb suppo ( om wo chai s o one chai o none), na -
owing he base o suppo , adjus ing speed o mo emen ,
inc easing gaming du a ion, and p oceeding o a highe
di icul y le el. P oceeding o a highe le el depends on a
pa icipan 's high sco e calcula ed as he sum o poin s o
he di e en asks (i.e., passed ga es, collec ed ui s, mem-
o ized i ems). The use s will ge di ec ( eal- ime) eed-
back abou hei p og ess by du a ion, sco e, and p og ess
in o ma ion (i.e., ime, missed ga es, co ec ly iden i ied
i ems) displayed on he sc een.
Muscle s eng h exe cises
The Ambien Assis ed Exe cise P og am (AAEP) o
iS oppFalls is based on he s eng h exe cise componen
o he O ago exe cise p og am [19]. I inco po a es exe -
cises o muscle s eng h o he lowe ex emi ies used
in ADL and balance eco e y: knee ex ension, knee
lexion, hip abduc ion, cal aises, and oe aises. Fo
muscle s eng h aining, 2 o 3 se s o 10 o 15 epe i-
ions and es pe iods o 2 min will be ecommended.
To ensu e echnically co ec mo emen s and maximal
ange o mo ion all use s will be p o ided wi h isual
and e bal ins uc ions. P og ession is achie ed by in-
c easing he numbe o epe i ions, he numbe o se s,
and he di icul y le el (e.g., by using he p o ided ankle
cu weigh s anging om 1 kg o 3 kg). Pa icipan s will
each he nex le el i hey co ec ly pe o m 3 sessions.
Use s will ge di ec ( eal- ime) eedback abou hei
p og ess by du a ion, numbe o epe i ions, adequacy o
mo emen s, and p og ess in o ma ion (e.g., pe cen age
o comple ed ask) displayed on he sc een (Figu e 4).
Educa ion ma e ial
The educa ional bookle con ains in o ma ion abou all
p e en ion, exe cise, heal hy ea ing, gene al heal h, oo -
wea , medica ion, en i onmen al haza ds, and eme gency
p ocedu es. I also includes a home sa e y checklis and a
all quiz. This con en is based on well-known isk ac o s
o alls, e idence-based all p e en ion in e en ions, and
guided by good p ac ice p inciples [21]. The educa ional
bookle aims o p omo e sel -managemen , and o e s sim-
ple and e ec i e s a egies o educe all isk.
Ou come measu es
Pa icipan s will be assessed a baseline (0 weeks), in he
middle (8 weeks), and a he end o he in e en ion
pe iod (16 weeks). The assessmen s will be conduc ed
unde s anda dized condi ions a he s udy cen es o in
ooms p o ided by he e i emen illages. Table 1 ou lines
he assessmen s pe o med a di e en ime poin s. Each
assessmen will ake abou wo hou s o comple e. When
a s opwa ch is used, ime will be eco ded o he nea es
0.01 s. Fo he Timed Up and Go (TUG), walking, and
senso -based assessmen s, pa icipan s will be wea ing a
SMM de ice as a necklace a he heigh o he s e num.
Demog aphic and gene al heal h
Pa icipan s will be sen a sel - epo ques ionnai e by
pos and will be eques ed o comple e i p io o he
baseline assessmen . We will collec in o ma ion on
socio-demog aphic cha ac e is ics (age, gende , ma i al
s a us, e hnici y, housing si ua ion, economic s a us, p e-
ious occupa ion, educa ion) and medical his o y (p es-
ence o medical condi ions, medica ion use, his o y o
alls). In addi ion, he ollowing ou come measu es will
be assessed a baseline and 16 weeks ollow-up.
The 12-i em Wo ld Heal h O ganiza ion Disabili y As-
sessmen Schedule (WHODAS) 2.0 is a gene ic assessmen
ins umen o six domains o gene al heal h: unde s and-
ing and communica ing, mobili y, sel -ca e, in e pe sonal
in e ac ions, household and wo k ac i i ies, and pa icipa-
ion in socie y (www.who.in /classi ica ions/ic /whodasii/
en/). This sel -adminis e ed ques ionnai e is sho , simple,
and easy o adminis e . I p oduces s anda dized disabili y
le els and p o iles linked o he In e na ional Classi ica ion
o Func ioning, Disabili y and Heal h (ICF) [22].
The Pa ien Heal h Ques ionnai e (PHQ-9) is a 9-i em
ques ionnai e o sc eening, diagnosing, moni o ing, and
measu ing he se e i y o dep ession [23]. Each i em is
sco ed om 0 (no a all) o 3 (nea ly e e y day) leading
o he diagnosis o minimal (0 o 4 poin s), mild (5 o 9
poin s), mode a e (10 o 14 poin s), mode a ely se e e
(15 o 19 poin s), and se e e (20 o 27 poin s)
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dep ession. The PHQ-9 showed excellen in e nal eli-
abili y (C onbach’s alpha = 0.86) and disc iminan alid-
i y (a ea unde he cu e = 0.95) [23].
The Eu opean Quali y o Li e –5 Dimensions (EQ-
5D-5-L) ques ionnai e was de eloped o gene a e a basic
heal h index (www.eu oqol.o g/eq-5d-p oduc s/eq-5d-
5l.h ml). Pa icipan s will desc ibe hei heal h s a us
in i e dimensions: mobili y, sel -ca e, usual ac i i ies,
pain/discom o , and anxie y/dep ession. Each dimension
has h ee possible le els: (i) no p oblem, (ii) mode a e
Figu e 3 Exe games o balance. (A) ‘Bumble Bee Pa k’: walking on he spo a oiding app oaching bumble bees, (B) ‘Hills n’Skills’: downhill
skiing aiming o he ga es, (C) ‘Balance Bis o’: s epping o he side collec ing ui s.
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p oblems, o (iii) ex eme p oblems. Thus, 243 heal h
s a es ep esen ed by a 5-digi combina ion can be de-
ined acco ding o he ele an le el wi hin each dimen-
sion (e.g., 11111 ep esen s no p oblems on any
dimension). In addi ion, pa icipan s will epo hei o e -
all heal h du ing he pas 30 days on a con inuous scale (0
o 100, highe sco e equals be e heal h pe cep ion) [24].
The Iconog aphical –Falls E icacy Scale (Icon-FES) is
an inno a i e way o assessing conce n abou alling [25].
As pa o he baseline assessmen s, he Icon-FES will be
used o in es iga e he pa icipan s’conce ns abou alling
(www.neu a.edu.au/apps/icon es). Thi y pic u es o daily
ac i i ies, each wi hin a speci ic en i onmen al con ex as-
socia ed wi h di e en p obabili ies abou alling (i.e., ak-
ing he escala o , going downs ai s), will be g aded by he
pa icipan on a 4-poin Like scale (1 = no a all con-
ce ned, 4 = e y conce ned). The Icon-FES has excellen
psychome ic p ope ies and shows close con inui y wi h
he Falls E icacy Scale In e na ional (Spea man’s ho=
0.742, P < .001) [25,26].
Physical and unc ional assessmen s
The Physiological P o ile Assessmen (PPA) sho e sion
will be applied o gene a e an o e all all isk sco e based
on es s which di ec ly assess senso imo o abili ies: con-
as sensi i i y (Melbou ne edge es (MET), pe iphe al
sensa ion (p op iocep ion), balance (sway when s anding
on medium-densi y oam wi h eyes open), lowe ex emi y
muscle s eng h (knee ex ension), and hand eac ion ime
[27]. In mul i a ia e models hese a iables p o ide an
o e all alls isk sco e, and can p edic hose a isk o all-
ing wi h 75% accu acy in communi y and e i emen il-
lage se ings. A PPA sco e indica es mild (<1), mode a e
(1–2), and ma ked (≥2) all isk in ela ion o a no ma i e
da abase. In addi ion, wo PPA long e sion es s o lean-
ing balance will be applied (coo dina ed s abili y es and
maximal balance ange es ).
The Sho Physical Pe o mance Ba e y (SPPB) will be
used o assess lowe ex emi y unc ion based on he ol-
lowing es s: s a ic balance (side-by-side, semi- andem,
and andem s ance), walking speed o e 4 m (a no mal
Figu e 4 S eng h exe cises o (A) hip abduc ion muscles and (B) back knee lexo muscles.
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pace), and he i e imes chai s and es [28]. Each es
will be assigned a sco e om 1 (wo s ) o 4 (bes ). Sum-
ming he ca ego y sco es o he h ee es s can be used
o c ea e a SPPB summa y pe o mance scale.
The TUG by Podsiadlo and Richa dson [29] will assess a
combina ion o basic unc ionali y, physical mobili y, and
dynamic balance [30,31]. On he wo d ‘go’, pa icipan s
will ha e o s and up om a chai , walk o a h ee me e
ma k, come back, and si down in he chai again. Time
will be eco ded wi h a s opwa ch om he wo d ‘go’un il
he pa icipan si s down. Tes - e es eliabili y o he
TUG in olde people is excellen (ICC = 0.99) [29].
S eady-s a e walking speed will be measu ed o e a
10 m dis ance (plus 2 m o accele a ion and 2 m o de-
cele a ion) by using a s op wa ch [32]. A he s a and he
inish he e will be a s anda d chai wi h a m es s posi-
ioned. All walks will be pe o med ba e oo . The pa ici-
pan s will be ins uc ed o walk a hei com o able
Table 1 S udy assessmen s by ime poin
Type o assessmen Ou come
a iable
Baseline assessmen s
(week 0)
Re-assessmen s
(week 8)
Pos -assessmen s
(week 16)
Heal h Demog aphics, heal h s a us, alls his o y NA X
12-i em WHODAS 2.0 Seconda y X X
Eu opean Quali y o Li e –5 Dimensions P ima y X X X
Iconog aphical –Falls E icacy Scale Seconda y X X X
Falls and exe cise adhe ence calenda s Seconda y Mon hly
Technical Technology use Seconda y X
SUS & PACES Seconda y X
TAM & UTAUT Seconda y X
A akDi 2 & AFSS & DART Seconda y X
Physical Physiological P o ile Assessmen P ima y X X
Sho Physical Pe o mance Ba e y Seconda y X X
Senso -based balance es s Seconda y X X X
Senso -based eac ion ime es s Seconda y X X X
Senso -based chai s and es Seconda y X X X
Timed Up and Go es Seconda y X X
S eady-s a e walking speed (single and dual ask) Seconda y X X
Hand g ip s eng h Seconda y X X
IPEQ o PAQ-50+ Seconda y X X X
Cogni ion Mini-Cog NA X
Addenb ooke’s Cogni i e Examina ion III Seconda y X X
T ail Making Tes Seconda y X X
Vic o ia S oop es Seconda y X X
Digi Symbol Coding es Seconda y X X
Digi Span Backwa d Seconda y X X
A en ion Ne wo k Tes Seconda y X X
Coun ing backwa ds by h ee Seconda y X X
iS oppFalls sys em Exe cise adhe ence Seconda y Con inuously
Use ac i i y (i.e., se op box, able ) Seconda y Con inuously
Kinec senso Range o mo ion Seconda y While exe cising
21 Join angles Seconda y While exe cising
SMM senso Walking dis ance (m) Seconda y Daily
Peak powe si - o-s and ans e s (W) Seconda y Daily
AFSS = Ac i i y Flow S a e Scale; DART = Dynamic Accep ance Model o he Re-e alua ion o Technologies; IPEQ = Inciden al and Planned Ac i i y Ques ionnai e;
NA = non-applicable; PACES = Physical Ac i i y Enjoymen Scale; PAQ-50+ = Physical Ac i i y Ques ionnai e o he popula ion aged 50 yea s and olde ;
SMM = Senio Mobili y Moni o ; SUS = Sys em Usabili y Scale; TAM = Technology Accep ance Model; UTAUT = Theo y o Accep ance and Use o Technology;
WHODAS = Wo ld Heal h O ganiza ion Disabili y Assessmen Schedule.
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no mal walking speed [33]. Time is eco ded wi h a s op
wa ch when he pa icipan ’s limb c osses he i s ma ke
un il he pa icipan ’s limb c osses he second ma ke .
Du ing he second walk, pa icipan s will be asked o
coun backwa ds by h ee s a ing om a andom 3-digi
numbe (dual- asking) [34]. The po en ial esul ing dual
ask in e e ence will gi e an indica ion o he ex en o
which olde people slow down when simul aneously walk-
ing and coun ing [35].
A hyd aulic hand g ip dynamome e (Eu ope: Jama
Dynamome e , La aye e Ins umen , La aye e, IN, USA;
Aus alia: No h Coas Hyd aulic Hand Dynamome e ,
No h Coas Medical, Inc., Mo gan Hill, CA, USA) will be
used o assess hand g ip muscle s eng h. Pa icipan s will
si in a com o able chai wi h he elbow lexed o 90 de-
g ees, he w is in a neu al posi ion, and he shoulde
adduc ed and neu ally o a ed. A e he pa icipan ex-
e s maximal o ce, s eng h is eco ded o he nea es
1 kg. Each pa icipan has h ee a emp s while he highes
sco e is used o analysis. Low muscle s eng h will be
classi ied as hand g ip s eng h <30 kg in men and <20 kg
in women acco ding o he Eu opean Wo king G oup on
Sa copenia in Olde People consensus pape [31].
To assess he pa icipan s’le el o physical ac i i y, he
Inciden al and Planned Ac i i y Ques ionnai e (IPEQ) [36]
will be used in he Aus alian and Spanish s udy a m. The
IPEQ consis s o a sel - epo ques ionnai e which o-
cusses on he equency and du a ion o se e al le els o
planned and inciden al physical ac i i y in olde people.
This ques ionnai e ocuses on weekly physical ac i i y in-
cluding planned exe cises o walks, and mo e casual day-
o-day ac i i ies. The o al du a ion o physical ac i i y is
summed ac oss all componen s and exp essed as hou s
pe week. Measu emen p ope ies and concu en alidi y
o he IPEQ ha e been epo ed o be excellen [36]. In
he Ge man s udy a m he Physical Ac i i y Ques ionnai e
o he popula ion aged 50 yea s and olde (PAQ-50+)
[37] will be applied. I e alua es physical ac i i y du ing an
a e age week o he pas mon h. This ques ionnai e es i-
ma es physical ac i i y o olde people based on exe cise,
housewo k, ga dening, job, and leisu e ac i i ies. By mul i-
plying he me abolic equi alen o an ac i i y by he du -
a ion o pe o ming he physical ac i i y an es ima e o
o al ene gy expendi u e can be ob ained. The PAQ-50+
showed an accep able es - e es eliabili y o 0.52 o
0.60 [37].
Senso -based physical assessmen s
Fou senso -based physical assessmen s using he iS opp-
Falls so wa e, he Mic oso Kinec , and he SMM will be
pe o med ba e oo in on o a TV: (1) Balance es s in-
clude com o able-bipedal, semi- andem, nea - andem,
and andem s ance (Figu e 5). Each balance ask will be e-
pea ed wice o a maximum du a ion o 30 s wi h he
p e e ed oo in on (no changes allowed be ween he
di e en s ances) and eyes open. A e he coun down
‘ eady, se , go’, ime will be s opped when he pa icipan
mo es his/he ee , ouches he chai o suppo , o suc-
cess ully eaches 30 s. (2) The hand eac ion ime es will
equi e pa icipan s o use hei hands o hi wo andomly
lashing ligh s posi ioned o he le and igh on a i ual
able. Two se s o 20 epe i ions will be pe o med. (3) Fo
he s epping eac ion ime es , wo andomly lashing
ligh s will be posi ioned o he le and igh on a i ual
loo . Pa icipan s will need o pe o m a la e al s ep on o
he lashing ligh as as as possible. S epping should in-
clude weigh -shi ing a he han only oo apping o he
side. Two se s o 20 epe i ions will be pe o med. (4) The
si - o-s and es is a unc ional measu e o lowe ex em-
i y s eng h, powe , and balance. Pa icipan s will be
ins uc ed o c oss hei a ms o e he abdomen, and ise
om a chai o i e imes as quickly as possible. Time
measu ed by a s op wa ch indica es insu icien (≥16.7 s),
su icien (13.7 s o 16.6 s), good (11.2 s o 13.6 s), and e y
good s eng h pe o mance (≤11.1 s) [38].
Figu e 5 Base o suppo du ing s a ic balance senso -based
assessmen s. (A) bipedal s ance, (B) nea - andem s ance,
(C) semi- andem s ance, (D) andem s ance. Pic u e by cou esy o
b u - Swiss Council o Acciden P e en ion.
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