exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour

14 Pages·2017·0.75 MB·English

Giné-Garrigaetal.Trials (2017) 18:221
DOI10.1186/s13063-017-1956-x
STUDY PROTOCOL Open Access
The SITLESS project: exercise referral
schemes enhanced by self-management
strategies to battle sedentary behaviour in
older adults: study protocol for a
randomised controlled trial
Maria Giné-Garriga1*, Laura Coll-Planas2, Míriam Guerra1, Àlex Domingo2, Marta Roqué2, Paolo Caserotti3,
Michael Denkinger4, Dietrich Rothenbacher5, Mark A. Tully6, Frank Kee6, Emma McIntosh7, Carme Martín-Borràs1,
Guillermo R. Oviedo1, Javier Jerez-Roig1, Marta Santiago1, Oriol Sansano1, Guillermo Varela1, Mathias Skjødt3,
Katharina Wirth4,5, Dhayana Dallmeier4, Jochen Klenk5, Jason J. Wilson6, Nicole E. Blackburn6, Manuela Deidda7,
Guillaume Lefebvre8, Denise González9 and Antoni Salvà2
Abstract
Background: Older adults are the fastest growing segmentof theworld‘spopulation. Recentevidence indicates
that excessivesitting time is harmful to health, independent ofmeeting the recommended moderateto vigorous
physical activity (PA) guidelines. The SITLESS projectaims to determine whether exercisereferral schemes (ERS) can
be enhanced by self-management strategies (SMSs) to reduce sedentarybehaviour (SB),increase PA and improve
health, qualityof life and function inthe long term, as wellas psychosocial outcomes in community-dwellingolder
European citizens from four countries, within a three-armed pragmatic randomised controlled trial, compared with
ERS alone and also with general recommendations about PA.
Methods: A total of1338 older adults will be included inthis study, recruited from four European countries
through different existing primary preventionpathways. Participants will be randomly allocated intoan ERS of
16 weeks (32 sessions, 45–60 min per session), ERS enhanced bysevensessions of SMSs and four telephone
prompts, or a control group. Outcomes will be assessed atbaseline, month 4 (end ofERS intervention), month 16
(12 months post intervention)and month 22 (18 months post intervention). Primary outcomes will include
measures of SB (time spent sedentary) and PA (counts per minute). Secondary outcomes will include muscle and
physical function, health economics’related outcomes, anthropometry, quality of life, social networks, anxiety and
depressive symptoms, disability, fear offalling, executive function and fatigue. A process evaluation will be
conducted throughout thetrial. The full analysis set will followan intention-to-treat principle and will includeall
randomised participants for whom a baseline assessment is conducted. The study hypothesis will be tested with
mixedlinear models with repeatedmeasures,to assess changes inthe main outcomes (SB and PA) over time
(baseline to month 22) and between study arms.
(Continuedonnextpage)
*Correspondence:[email protected]
1FacultatdePsicologia,Ciènciesdel’Educacióidel’EsportBlanquerna
(UniversitatRamonLlull),C/Císter34,08022Barcelona,Spain
Fulllistofauthorinformationisavailableattheendofthearticle
©TheAuthor(s).2017OpenAccessThisarticleisdistributedunderthetermsoftheCreativeCommonsAttribution4.0
InternationalLicense(http://creativecommons.org/licenses/by/4.0/),whichpermitsunrestricteduse,distribution,and
reproductioninanymedium,providedyougiveappropriatecredittotheoriginalauthor(s)andthesource,providealinkto
theCreativeCommonslicense,andindicateifchangesweremade.TheCreativeCommonsPublicDomainDedicationwaiver
(http://creativecommons.org/publicdomain/zero/1.0/)appliestothedatamadeavailableinthisarticle,unlessotherwisestated.
Giné-Garrigaetal.Trials (2017) 18:221 Page2of14
(Continuedfrompreviouspage)
Discussion: The findings of this study may helpinform thedesign and implementation of more effective
interventions to reduce SB and increasePA levels, and hence improve long-term health outcomes intheolder
adult population.SITLESS aims to supportpolicy-makers indecidinghow or whether ERS should be further
implemented or restructured inorder to increaseits adherence, impact and cost-effectiveness.
Trial registration: ClinicalTrials.gov, NCT02629666. Registered 19 November 2015.
Keywords: Sedentary behaviour, Physical activity, Behaviour change,Older adults, Self-management strategies
Background the use of established behavioural change techniques
Older adults are the fastest growing segment of the (BCTs) to promote increased levels of PA [23]. Among
world’s population [1]. Although prolonging life remains those, self-management strategies (SMSs) may success-
an important public health goal, of even greater signifi- fully improve involvement in exercise in specific popula-
canceisthepreservationoffunctionalandcognitiveper- tions, increasing levels of daily PA, enhancing quality of
formance, and of the capacity to live independently life, improving mental health, producing greater confi-
duringlatelife. dence andincreasing powertoact[24].
Being insufficiently active is associated with increased Research focusing on interventions to reduce SB has
risk for major non-communicable diseases and all-cause only begun to emerge in the last five years and there
mortality, which is related to increased healthcare costs have been few studies conducted in older adults. Recent
[2–4]. It is estimated that people aged 65 years and over studies targeting reduced SB in this population have in-
account for 30–40% of the total healthcare spend across cluded BCTs such as goal setting, instruction on how to
Europe [5]. The burden of disease attributable to being perform the behaviour, self-monitoring and feedback of
insufficiently physically active has recently been esti- behaviour, prompts/cues and restructuring the physical
mated to be responsible for 6–9% of the total deaths environment [25–29]. Moderate quality evidence indi-
worldwide and accounts for as many as 5.3 million cates that specific interventions have the potential to re-
deaths per year [2, 6]. In this context, it is estimated that duce SB in older adults [30]. These findings are
across allages,31%oftheglobalpopulation donot meet supported by systematic reviews focusing on adults [31–
current physical activity (PA) recommendations estab- 33]. As far as we know, no previous studies have
lished bytheWorld HealthOrganization(WHO)[7]. assessed the effectsof anexercise-based intervention en-
In the last decade, growing evidence indicates that ex- hanced by SMSs addressing both increased daily PA and
cessive sitting time may be harmful to health, independ- areductionofSB inolder adults.
ent of meeting the recommended moderate-to-vigorous Therefore, the SITLESS project aims to determine
PA guidelines [8–13]. Time spent in sedentarybehaviour whetherERScanbeenhancedbySMSstoreduceSB,in-
(SB)—defined as any waking behaviour characterised by crease PA and improve health, quality of life and func-
energy expenditure≤1.5 Metabolic Equivalent Tasks tion in the long term (22 months), as well as
(MET) while in a sitting or reclining posture [14]—has psychosocial outcomes in community-dwelling older
increased substantially over the last three decades [15]. European citizens from four countries, within a three-
Older adults are the most sedentary segment of society, armed pragmatic randomised controlled trial (RCT),
as many spend over 75% of their waking day in SB [16]. compared with ERS alone and also with general recom-
Current evidence suggests that prolonged SB is associ- mendations about PA. SITLESS will also collect health
ated with increased rates of several chronic diseases and economics’related outcomes,data onhealthcare systems
all-causemortality inolder adults[17–20]. and community costs to perform cost-effectiveness ana-
Primary care is a key setting for the promotion of PA. lyses. SITLESShasthe purpose tosupportpolicy-makers
The most common model of PA promotion in primary in deciding how or whether ERS should be further im-
care involves exercise referral schemes (ERS), whereby a plemented or restructured in order to increase its adher-
general practitioner or another member of the primary ence, impactandcost-effectiveness.
care team (e.g. physiotherapist, nurse or pharmacist)
identifies and refers insufficiently active individuals to a Methods/design
third-party service (often a sports centre or leisure facil- Studydesign
ity) to conduct an exercise program [21, 22]. Despite re- The present study protocol describes a multi-centre
cent studies showing the health benefits of such pragmatic three-armed parallel RCT. Outcomes will be
programs, most studies also demonstrate that such gains assessed at baseline, month 4 (end of intervention),
are rarely sustained [21]. Recent guidelines also advocate month 16 (12 months post intervention) and month 22
Giné-Garrigaetal.Trials (2017) 18:221 Page3of14
(18 months post intervention) which will be the main doing the activity) (do not count regular walking)’; and/
outcomeassessment. Thestudyprotocolhasbeendevel- or (6) report spending long periods of time in SB by an-
oped based on the Standard Protocol Items: Recommen- swering affirmatively to the question: ‘For most days, do
dations for Interventional Trials (SPIRIT) guidelines you feel you sit for too long (6–8 hours or more a day)?
[34]. The study design was approved by the Ethics and Some examples might include when watching TV, work-
Research Committee of each intervention site: The Eth- ing at the computer / laptop or when doing sitting-based
ics and Research Committee of Ramon Llull University hobbies such as sewing’ [17]. Participants will be ex-
(Fundació Blanquerna, Spain),The Regional Committees cluded if they: (1) have moderate or severe dementia
on Health Research Ethics for Southern Denmark (Uni- when screened with the six-item screener to identify
versity of Southern Denmark, Denmark), Office for Re- cognitiveimpairment,usingacutoffofthree ormore er-
search Ethics Committees in Northern Ireland rors [36]; (2) have a medical condition which may inter-
(ORECNI) (Queen’s University of Belfast) and the Eth- fere with the study design; (3) have unstable medical
ical Review Board of Ulm University (Ulm, Germany). conditions (e.g. elevated blood pressure after medication,
Participation is voluntary and all participants will be uncontrolled hypertension) or symptomatic cardiovascu-
asked to sign informed consent before the start of the lar diseases that contraindicates participation in PA; (4)
study (seeAdditionalfile1). expect not to be able to attend 75% of the ERS sessions
SITLESS, as a Responsible Research and Innovation throughout the intervention; and (5) have participated in
project, has created guidance for the involvement of an ERS in the six months prior to their entry into the
stakeholders in the project from the onset. Accordingly, study.
four local advisory boards were created, one on each
intervention site (Barcelona, Odense, Belfast, Ulm) and Samplesize
are periodically involved in the study. They comprise A sample size of 1338 participants (randomised to one
primary healthcare and sport professionals, older adults, ofthreegroupsof446participants)willbeneededtode-
policy-makers and other local stakeholders of relevance tect a moderate effect size of 30 daily counts per minute
(e.g. health insurance, where relevant). A gender expert (CPM) in a two-sided test, at a power of 80% and an α
linked to the European project EGERA is part of the ad- of 0.05, a common standard deviation of 139 of the
visory boardofBarcelona. mean and a 24% dropout rate. A change of 30 CPM is
considered a measurable moderate effect size in this
Participants population, assessed with ActiGraph GT3X+, and 139 is
A total of 1338 participants (randomised into three the standard deviation for CPM found in the literature
intervention groups of 446 participants) will be included [37]. The present sample size allows estimation of over-
in this study and recruited in four intervention sites allefficacy.
(Barcelona, Odense, Belfast, Ulm). Each intervention site Sample size computations were conducted with online
will be in charge of recruiting 335 participants and will software GRANMO (http://www.imim.es/ofertadeser-
collect relevant descriptive information regarding partic- veis/software-public/granmo/; last accessed on 21/7/
ipants’ demographic characteristics (e.g. age, gender, 2014).
marital status, living arrangements and educational
background). Barcelona is the largest site of the study Studyprocedure
with 1,602,000 inhabitants in 2014, followed by Belfast Recruitment strategies will be site-specific according to
with 333,871 at the 2015 census. Odense and Ulm have the different existing primary prevention pathways in
less than 200,000 inhabitants. Outcome measures will be each country. Primary care centres and other health-
alsoanalysedtodetectany between-sitedifferences. related centres of each intervention site will be informed
Participantsareeligible ifthey are: (1)aged 65years or and asked to participate. The research team will inform
above; (2) community-dwelling; (3) able to walk without professionals about the background and the aims of the
the help of another person for at least 2 min with or study. Health professionals who volunteer to participate
without a walking aid; (4) have no major physical limita- will be further given all information regarding eligibility
tions as shown by a score on the Short Physical Per- criteria and the recruitment strategy. Posters, flyers, news-
formance Battery (SPPB) of 4 or above [35]; (5) papers, radio broadcasts and social media outlets will also
insufficiently active as determined by the following beusedtoadvertisethestudyandasadditionalrecruitment
screening question: ‘Do you perform regular physical ac- strategies(Additionalfile2:showstheSPIRITchecklist).
tivity (PA) for at least 30 minutes five or more days of Health professionals or the local research team will as-
the week (referring only to PA that makes the participant sess interested individuals against the eligibility criteria.
become out of breath while doing it or such that it Eligible participants will have their name, gender, date of
doesn’t allow him/her to maintain a conversation while birth and phone number recorded, while individuals
Giné-Garrigaetal.Trials (2017) 18:221 Page4of14
deemed ineligible or that do not want to participate will The ERS program will be based on a combination of
have their reason for declining as well as their gender aerobic, strength-based and balance activities. Aerobic
andagerecorded. training may include walking, rowing, using an elliptical
trainer, cycling, fitness/water aerobics, Nordic walking,
swimming, dancing and/or any other activity such as
Randomisationandblinding
games which increase heart rate and respiratory fre-
During the first meeting, a researcher will explain the
quency. During the first week, these activities will be
trial to interested individuals, give them an information
performed at a moderate intensity, with bout duration
sheet about the study and obtain their written informed
based on each individual aerobic level. Progression will
consent (see Additional file 1). Participants will then be
include increasing the duration and/or the intensity (e.g.
scheduled for the baseline testing session. After the
increasingresistanceonthebikeergometerorincreasing
baseline assessment, each participant will be centrally
walking speed on Nordic walking) up to a maximum of
randomised to one of the three study groups (e.g. ERS+
9 of the same Borg Scale. The intervention will be tai-
SMS, ERS or the control group), using a computer-
lored for the participants with a low functional level
based random-block randomisation scheme, clustering
(score of 4–6 of the SPPB), in which more strength
bycoupleswhencohabiteeswishtobeenrolledtogether.
trainingwillbeperformed.
Concealed randomisation will be conducted centrally at
Lower-body strength exercises will include functional
FSiE, after each participant has been included in the
tasks such as rising from a chair, stair climbing, knee
study, assigned an identification code and has completed
bends,floortransfer,walking, lunges, legsquat,legexten-
thestudybaselineassessment.
sion,leg flexion,calfraise,lowerbackandabdominalcurl
The trial has an open design with blind assessment of
using ankle weights, elastic bands, training devices (e.g.
outcomes. Researchers conducting the baseline assess-
legpress),freeweightsoranyothermaterialavailable(e.g.
ments will be blind to group allocation. The statistician
waterbottlesorsandsacks).Upper-bodyexercisesmayin-
will also be blind to group allocation until completion of
cludepulldowns,lowrow,chestpress,shoulderpressand
the statistical analysis. Participants will be asked not to
biceps curl. The first session will be used to calculate the
reveal group allocationwhenundergoing follow-upmea-
baseline intensity. The first two weeks of the intervention
surements, as researchers conducting follow-up mea-
willbeusedasfamiliarisation,withthefocusontechnique
surements will be blind to group allocation. To assess
of the different exercises. Following the two-week period,
the extent to which blinding has been preserved, re-
trainingintensitywillbeindividuallycalculatedbythe4–8
searchers will record the number of cases in which allo-
repetition maximum method (i.e. maximum number of
cation wasrevealed.
repetitions to failure between 4 and 8) for each exercise
using different training tools devices (e.g. fixed weights
Studyinterventions
machine,freeweights,elasticbands)andbodyweight(e.g.
A complex intervention [38] consisting of a PA program
loaded sit-to-stand, squats, lunges). Lower-body exercises
with self-management strategies (ERS+SMS) will be de-
will be performed explosively (e.g. as rapid as possible)
livered in primary care or community settings in urban
during the concentric phase of the movement and con-
areas of Barcelona (Spain), Odense (Denmark), Belfast
trolledduringtheeccentricphase.
(UK) and Ulm (Germany) (see Table 1). All trainers in
Balance-based exercises will focus on functional activ-
charge of conducting both intervention groups will
ities. Balance activities will be designed to challenge the
undergoa standardisedtraining.
visual (e.g. eyes open/closed), vestibular (e.g. move head)
and somatosensory (e.g. stand on foam) systems. Static
Physicalactivityintervention(ERS) balance will consist of two-leg and one-leg balance with
Participants will undergo a 16-week PA program, con- toes or heels raised and tandem standing with eyes open
sisting of two sessions per week (45–60 min each ses- or closed on different surfaces. When training dynamic
sion). Participants will be asked to perform the activity balance, activities such as walking on different surfaces,
at a moderate-to-vigorous intensity (according to each with varied elevations, and performing a dual task (cog-
individual’s fitness levels) during the main part of each nitive and functional task such as catching, throwing
session. Intensity will be estimated using the modified and reaching), incorporating different gait patterns (e.g.
Borg Scale of Perceived Exertion [39] (e.g. moderate- narrow walking, longer strides, zigzag walking) and vari-
intensity activity will be considered 4–6 and vigorous- ations in gait speed, will be performed. Balance exercises
intensity activity will be 7–9) or with training loads (i.e. will include function-focused activities such as walking
ankle weights and dumbbells) corresponding to 70–80% with obstacles while wearing standard sunglasses (worn
of one repetition maximum, adjusted progressively dur- over corrective lenses as needed) to mimic a semi-dark
ingthetrainingperiod. environment, walking while carrying a package that
Giné-Garrigaetal.Trials (2017) 18:221 Page5of14
Table1GeneralinformationoftheERSandSMSinterventions
Nameof Programcomponents Trainingresponsible Duration Generalstructureofeachsession
the
program
ERS Aerobictraining.Strength- SpeciallytrainedPAspecialist: 16weeks.Twosessionsper Alltrainingsessionswillbegin
intervention based/enduranceexercises. physicaltherapist;sport weekof45–60min.Askeach witha5–10minwarm-up
Balance-basedfunctional professional/trainer; participanttoperformathird focusingonsocialandphysical
exercises.Flexibilityexercises. ergotherapistwithspecific sessionontheirownsuchasa interactions.Followedby35min
healthqualification.Sessions 30-minwalk.Theintervention ofdifferentexercisesadaptedto
willbealwaysperformedunder willbeconductedinanindoor eachindividual’sfunctionallevel
thesupervisionofthesame primary-careorsportsfacility. (accordingtotheparticipants’
trainer. Municipalityfacilities(e.g.activity SPPBscorea).Alltrainingsessions
centresforolderadults). willendwithcool-down
(breathingexercisesand
stretchingfor5–10min.
SMS Raisingawarenesson ThesamespecialistfortheERS Totalof30weeks.1one-to-one TheSMSsessionsincludethe
intervention differences,associations,risks intervention. session(week1;40min).6 followingactivities:introducing
andbenefitsofSBandPA. group-basedsessions(weeks3, theprojecttotheparticipant,
Settingpersonalactivitygoals 4,5,7,9and11;45–60min).4 developingarapport,settinga
(long-termachievementgoals). telephonecalls(weeks15,20,25 meaningfullong-termgoalto
Enhancingmotivation. and30;20min). beachievedattheendofthe
Goal-settingfocusingseparately intervention,identifying
onSBandPA.Self-monitoring facilitatorsandbarriersofPA
(pedometerandactivitydiary). andSBathomeand
Externalmonitoring(instructor). neighbourhoodinagroup
Problem-solvingaccordingto dynamic,environmental
theIDEA.bSocialinfluenceand signpostingtohelpengaging
socialsupport.Raising participantsinlocal
awarenessonfacilitatorsand opportunitiestodoPA,checking
barriersofPAandSBathome dailystepcountsregisteredin
andneighbourhood. theactivitydiaryandsetting
Environmentalsignposting. individualgoalstoincreasesteps
orotherphysicalactivities,set-
tingindividualgoalstoreduce
sitingtimesetchoosing
recommendations(SITLESStips)
fordecreasingSB,problem-
solvingtechniquestoovercome
barrierstobeinglesssedentary
andmoreactiveaccordingto
theIDEAbproblem-solving.
aTotalSPPBscorerangesfrom0(worstperformance)to12(bestperformance);participantswillbeclassifiedintothreedifferentfunctionalperformancelevels
accordingtotheresultsobtained:low=4–6;medium=7–9;highfunctionallevel=10–12points
bIDEAIdentifyingtheproblem,Developalistofsolutions,EvaluatethesolutionsandAnalysehowtheplanworked
obstructed the view of the feet and walking while picking out. A systematic review of interventions which aimed
upobjectsfromthefloor.Initiallytheparticipantswillper- to reduce SB in older adults was undertaken to identify
form one or two sets of 6–8 repetitions of each exercise; the components of these interventions, particularly
thenumberofrepetitionswillbeincreasedwhenapartici- BCTs. Once these were established, each intervention
pant is able to complete eight repetitions showing no diffi- site conducted focus groups with older adults in order
culty; the maximum number of repetitions will be 20. togettheiropinionsontheproposedBCTswhichwould
Threesetsofexercisesofincreasingcomplexitywillbede- be utilised in the SMSs intervention. On completion of
signed;whenaneasierstepwillbeachievedwithoutassist- both these tasks, and guided by social-cognitive theory,
ance,theindividualwillbeaskedtoperformthenextmore an initial logic model was developed to help determine
complexsetofexercises. how different intervention components (i.e. inputs)
Participants will be encouraged to report any negative might have an impact on the proposed study outcomes
sign or symptom resulting from the exercises during the (e.g. SB, PA, quality of life and functional capacity). The
sessions.A brief summary on theERSand SMSs interven- initialSMSsinterventionwastestedbyeachintervention
tionscanbefoundinTable1. site as part of a feasibility study before it was refined for
the final SITLESS trial. SMSs training materials were de-
ERS+SMSsessions veloped and workshops were conducted by each partner
In order to fully inform the development of the SMSs to help fully explain the SMSs intervention to the in-
intervention, a number of preliminary steps were carried structors. Monitoring and support for the SMSs
Giné-Garrigaetal.Trials (2017) 18:221 Page6of14
instructors is planned on a monthly basis using a mix- opportunity to improve participants’ motivation and in-
tureofface-to-facemeetingsandteleconferences. crease the levelofsocial support tositting lessandbeing
Participants randomised to this group will take part in moreactive.Eachgroup-basedsessionisexpectedtolast
a local ERS combined with SMS intervention lasting approximately 45–60min.
30 weeks in total. Both the ERS and SMS sessions will Four telephone calls (Adherence Stage): the main aims
be led by suitably qualified fitness instructors who have of the telephone calls are to provide motivational sup-
been previously trained regarding the SMS intervention. port and advice to participants to sit less and be more
There will be 11 SMS sessions: one taking place before activeaswellastryingtounderstandandsupportpartic-
the ERS intervention, seven during the ERS intervention ipants to maintain their goals (daily step counts, weekly
and three after the ERS. BCTs will be used to guide the time in PA / exercise and SITLESS tips). Each telephone
structure and content of the sessions [40]. These ses- callisexpectedtolastnomore than 20min.
sions will consist of a one-to-one session, six group-
based sessions in local leisure / community centres and Controlgroup(CG)
four telephone calls to offer additional support to the Researchers will give to all participants during the first
participants and tofindhow they are getting on with the informative meeting (prior assessment) a written general
SMS intervention. The SMS sessions will be structured booklet standardised across sites with the WHO recom-
aslistedbelow. mendation regarding PA regular practice for health.
One-to-one visit (Familiarisation Stage): the main aims During the intervention, a health advice meeting with
of the one-to-one visit will be to introduce the SMSs standardised topics about healthy lifestyle and feedback
intervention and materials to the participant and to start on some outcomes will be held twice in the Primary
developing a rapport. The participant will be given an Health Centre (at week 5 and at week 11). Researchers
information booklet which will give further details on SB will send a letter or make a phone call prior to the next
and some ideas on how to sit less and be more active assessment.
(i.e. SITLESS tips). The participant will also be given a
Yamax DigiWalker SW-200 pedometer to wear during Outcomeassessment
the course of the SMSs intervention and will be shown The ERS group will take 16 weeks and the ERS+SMS
how to put this on by the instructor (the participant in- group willtake 30weeks(includingthefour phone calls)
formation booklet will contain instructions on how to (see Fig. 1). Assessments will be conducted by the same
use the pedometer). The participant will be given an ac- assessors at the following time points: T0=baseline pre-
tivity diary to use during the duration of the SMSs inter- intervention, T1=at month 4 post intervention, T2=at
vention to monitor their daily step counts, weekly time month 16 (12 months after the end of the intervention),
in PA / exercise and use of SITLESS tips. This will also and T3=at month 22 (18 months after the end of the
allow them to monitor their daily step counts and intervention). (Fig. 2 shows the SPIRIT figure). All re-
weekly time in PA / exercise during the first three weeks searchers in charge of conducting the assessments will
of the intervention in order to develop baseline readings undergoa standardisedtrainingsession.
before the first group-based session. The final task will Personal information regarding age, gender, marital
be to establish long-term functional goals that the par- status, living arrangement, educational background,
ticipant would like to achieve in the months after com- medical conditions, and smoking and alcohol habits will
pleting the intervention. The one-to-one visit is be collected atbaseline.
expected tolastapproximately50min. The costs of the interventions (ERS, SMS and the CG
Six group-based sessions in the local leisure or com- intervention) will be also collected by a structured
munity centre (Ramping and Maintenance Stages): the questionnaire.
main aims of the group-based sessions will be to retrieve Primary outcomes of the study include: (1) SB as sit-
the participants’step counts and weekly time in PA / ex- ting time and the number of minutes spent in activities
ercise recorded in their activity diaries and their use of requiring≤1.5 MET, as objectively measured by hip
SITLESS tips as well as agreeing on participants’ goals worn ActiGraph® accelerometer, and in addition with
for the following weeks. The participants will be encour- ActivPal® (used in Barcelona and Ulm) and Axivity®
aged to gradually increase their daily step counts, weekly (used in Odense and Belfast) accelerometers worn on
time in PA / exercise and their use of the SITLESS tips. the thigh, and as self-reported according to the Patient-
Each group-based session will also cover a specific centered Assessment and Counseling for Exercise
theme such as goal-setting, identifying barriers and facil- (PACE), Sedentary Behavior Questionnaire); and (2)
itators for PA and SB in the neighbourhood and at physical activity as daily CPM and intensity of exercise
home, environmental signposting and problem-solving performed,asmeasuredbyActiGraph®.Primaryandsec-
techniques. It is hoped that these sessions will act as an ondary measures will be collected at the four time
Giné-Garrigaetal.Trials (2017) 18:221 Page7of14
Fig.1ScheduleofSITLESSinterventions
points. For an overview of primary and secondary out- aswellasCHEERSguidelinesforthereportingofthere-
comes, outcome measures, instruments and assessment sults[42,43].
time points,seeTable 2. Being a population health intervention conducted in a
multi-country setting, the health economic evaluation of
the SITLESS intervention poses specific additional chal-
Economicevaluation lenges related to the evaluation of complex public health
The health economic evaluation performed alongside interventions of this type [44] as well as to the multi-
the SITLESS clinical trial will be integral to the main country natureoftheintervention.
RCT, providing useful guidance upon the cost- The costs of providing the ERS enhanced by SMSs
effectiveness of the intervention. It will be conducted (the ‘intervention’ costs) will be identified from a na-
following NICE [41] recent economics method guidance tional health service/publicly funded and personal social
for the implementation of the cost-effectiveness analysis, services perspective alongside potential cost impacts
Giné-Garrigaetal.Trials (2017) 18:221 Page8of14
Fig.2SPIRITfigure
(costsincurredaswellascostsavings)includinghospita- available, country-specific tariffs will be used to evaluate
lisations, accident and emergency visits, appointments health outcomes.
with health professionals (health visitor, general practi- The within trial analysis will explicitly take the multi-
tioner contacts) as well as personal social services (i.e. country nature of the SITLESS trial into account, by
social servicesandcommunitycare). using appropriate methodologies as suggested by the
Aneconomiclogicmodelwillbedevelopedtosystemat- most recent literature and best practices. The multi-
ically identifyall relevant costsand cost savings as well as national feature of the SITLESS trial implies a hierarch-
toidentifypotentiallongertermcostimpacts.Followinga ical structure of the data and unobserved heterogeneity
multi-country costing approach, costs will be evaluated between clusters that needs to be adequately modelled
usingcountry-specificunitcostestimatesweights;further- with appropriate statistical and econometric techniques
more,costswillbetranslatedintoacommoncurrencyby [51, 52]. Following best practice approaches [53–55] a
using the PPP statistic reported by OECD. Unit cost data multiple imputation procedure using chained equations
will be identified from routine country-specific sources: (MICE) will be used to impute missing data separately
NHS Reference Costs, PSSRU (UK); InEK - Institute for foreacharmofthetrial.
the Hospital Remuneration System (Germany); Health Within-trial results will be reported and presented as
Department of Catalonia (Spain); Danish National Health an incremental cost-utility ratio with the joint distribu-
Register (Denmark) in order to use country-specific price tion of cost/utility pairs being represented on the cost-
weights. Furthermore, cross-country comparability be- effectiveness plane and with a cost-effectiveness accept-
tweendatasourceswillbechecked. ability curve(CEAC) [56].
As for the outcomes, self-reported health-related The within-trial economic evaluation results will be
quality-adjusted life-years (QALYs) will be obtained combined with evidence from the literature linking
using the EQ-5D-5 L EuroQol [45, 46] instrument as short-term outcomes with longer-term outcomes to pro-
well as the newly developed capabilities measure of out- duce a long-term cost-effectiveness decision analytic
comes for older people, the ICECAP-O instrument [47]. model. A Markov model will be the envisaged analytic
The multinational aspect of the analysis requires the use tool to evaluate population health interventions and to
of country-specific tariffs, which reflect country-specific examine outcomes over an extended period of time and
differences in health perceptions and preferences and it will be developed alongside Frew et al. [57] and Roux
might severelyaffectCost-Utilityanalysis[48–50].When et al. [58]. However, given that such long-term impacts
Giné-Garrigaetal.Trials (2017) 18:221 Page9of14
Table2Overviewofoutcomes,outcomemeasures,instrumentsandassessmenttimepoints
Outcomes Outcomemeasures Instrument Assessment
timepointa
Personalinformation Age,gender,civilstatus,living Primarycarerecords T0
arrangement,educationalbackground, Self-report
medicalconditions,andsmoking
andalcoholhabits.
Primaryoutcomes
Sedentarybehaviour Sittingtimeandthenumberof Actigraph® T0,T1,T2,T3
minutesspentinactivities ActivPal®
requiring≤1.5Metabolic Axivity®
EquivalentTasks. SedentaryBehavior
Questionnaire
Physicalactivity Dailycountsperminuteand Actigraph® T0,T1,T2,T3
intensityofexercise,
anddailystepcounts.
Secondaryoutcomes
Physicalfunction GeneralfunctionAerobic SPPB T0,T1,T2,T3
capacityStaticbalance 2-minutes’walktest
Unipedalstance
Musclefunction Handgripstrength TakeianalogueHand T0,T1,T2,T3
GripDynamometer
Meanstrengthandpower Linearencoder
withconcentriccontraction
ofisoinertialmovement
performing3exercises:(a)30-s
chairstandrise;(b)fiverepetitions
ofarmcurlwithbothhands
usinga2-kgand4-kgweight;
and(c)fourcounter-movementjumps.
Healtheconomics’ Useofsportservices,anduse Interview T0,T1,T2,T3
relatedoutcomes ofhealthandsocialservices,
medications,numberoffalls.
Anthropometry Weight,height,bodymass T0,T1,T2,T3
index,waistandhipcircumference.
Bioimpedance %fat;%muscle TanitaBC420SMA T0,T1,T2,T3
bioimpedanceanalyser
Bloodpressure Systolicanddiastolicblood OMRONM6comfort T0,T1,T2,T3
pressure;heartrate.
ActivitiesofDailyLiving 6-itemquestionnaire T0,T1,T2,T3
Self-ratedhealthand SF-12 T0,T1,T2,T3
health-relatedqualityoflife EUROQOL-5D
ICECAP-O
Anxiety HADS T0,T1,T2,T3
Depressivesymptoms HADS T0,T1,T2,T3
Socialnetwork LubbenSocialNetworkScale-6 T0,T1,T2,T3
Physicalactivity 12-itemPhysicalActivity T0,T1,T2,T3
self-regulation Self-RegulationScale
Self-efficacyforexercise Marcus’sSelf-Efficacy T0,T1,T2,T3
Questionnaire
Disability ShortformLateLifeFunction T0,T1,T2,T3
andDisabilityIndex
Fearoffalling ShortFallsEfficacy T0,T1,T2,T3
Scale–International
Loneliness ShortformDeJongGierveld T0,T1,T2,T3
LonelinessScale
Executivefunction TrailMakingTest T0,T1,T2,T3
Physicalfatigue PittsburgFatigabilityScale T0,T1,T2,T3
Inasubsample:
Giné-Garrigaetal.Trials (2017) 18:221 Page10of14
Table2Overviewofoutcomes,outcomemeasures,instrumentsandassessmenttimepoints(Continued)
Leveloffrailty-associated IL-6,hsCRP,TNF-alpha,IGF-1. Bloodsample T0,T1
biomarkersandinflammation
Sarcopenia-associated Myostatin,IL-6,IL-8,IL-15, Musclebiopsy T1
markersofmusclequality VEGF,BDNF,FGF21,irisin,
myostatin,Type2/Type1
fibreratio,Wntand
Notchsignaling,CDC42
aAssessmenttimepoints:T0=baselinepre-intervention,T1=atmonth4postintervention,T2=atmonth16(12monthsaftertheendoftheinter-
vention),andT3=atmonth22(18monthsaftertheendoftheintervention)
SPPBShortPhysicalPerformanceBattery,ICECAP-OICEpopCAPabilitymeasureforOlderpeople,HADSHospitalAnxietyandDepressionScale
are likely to be reliant on some untestable assumptions, assessment and of the post-intervention period, respect-
the model will comprise a detailed sensitivity analysis to ively, will be used as a main exposure marker to be ana-
explore how cost-effectiveness will vary within all realis- lysed in relationship to the various biomarker
ticrangesofcostsandoutcomes. measurements. Beside descriptive and summary mea-
As recommended by the UK’s NICE guidance on eco- sures we will use a multivariable analysis approach to
nomic evaluation of population health interventions an quantify the relationship, and simultaneously adjusting
annual population health discount rate of 1.5% will be for potential confounders such as age, gender and co-
applied tocostsandoutcomes. morbidities.
Ancillarybloodandmusclesub-studies Processevaluation
Two sub-studies will be performed to further elucidate SITLESS follows the guidance on ‘Process evaluation of
possible mechanistic pathways between SB, PA and our complex interventions’ from the Medical Research
primary and secondary outcomes. Biomarkers will be Council (MRC) for conducting the process evaluation of
assessed at baseline and after intervention in blood sam- the study [59]. It was applied in the feasibility study to
plesandonly aftertheintervention inmusclebiopsies. understand the feasibility of the recruitment strategy
and of the SMS intervention and, hence, optimise its de-
SubprojectA signandevaluation forthefull trial.
Subproject A is an analysis of changes in established The process evaluation of the full trial will be coordi-
core blood biomarkers associated with the intervention. nated by a non-intervention site and is aimed at provid-
This exploratory sub-study will analyse blood samples ing greater confidence in conclusions about effectiveness
from 456 participants (95 participants per arm from two of the intervention by assessing: (1) the quantity and
interventional sites n=570, considering 20% loss of quality of what was delivered (implementation) regard-
follow-up n=456). Blood will be drawn from partici- ing the PA and the SMSs interventions; and (2) the gen-
pants at baseline (T0) and at T1 to explore whether the eralisability by understanding the role of context.
intervention modifies established and accessible blood Moreover,the process evaluation will help to understand
biomarkers (IL-6, hsCRP,TNF-alpha, IGF-1, WBC, RBC, themechanisms ofimpact.
platelets). Irrespective of the study arm, all participants All intervention sites will combine their findings to
with an improvement in PA will be analysed and com- gain a greater understanding of how the SMSs and the
pared tothose withoutimprovementinPA. PA interventions are implemented and the extent to
which they work. Methodologically, basic quantitative
SubprojectB measures of implementation such as fidelity and adher-
Subproject B is an analysis of post-intervention effects ence will be combined with qualitative data, including
on muscle fibres or muscle tissue components in older observation on sessions, focus groups and interviews
adults. This exploratory sub-study will analyse muscle with a purposeful sample of participants with different
tissue from 60 participants to generate hypotheses on profiles. Moreover, the sessions on monitoring and sup-
potential effects of reducing SB on muscle tissue. The port of the SMSs instructors will be used to gather fur-
muscle biopsy will be performed at week 21 (after asses- ther information on implementation challenges.
sing the post-intervention activity level with accelerome- Researchteamswillprovide contextinformation oneach
ters) from a biopsy specialist and biomarkers will be intervention site.
assessed (Myostatin, IL-8, IL-15, VEGF, BDNF, FGF21, Qualitativeandquantitativefindingswillbetriangulated
irisin,Type 2/Type 1 fibre ratio, Wnt and Notch signal- according to a standardised protocol that will entail: (1)
ling, CDC42). In this exploratory analysis, the physical sortingthemesandfollowingthreads;and,whererelevant,
activity profile or the sedentary profile from baseline (2) seeking convergence, complementarity, silence and