An
evaluation
of
a
nurse-led
rehabilitation
programme
(the
ProBalance
Programme)
to
improve
balance
and
reduce
fall
risk
of
community-dwelling
older
people:
A
randomised
controlled
trial
Bruna
Raquel
Gouveia
a,b,*
,
Helena
Gonc¸alves
Jardim
c,
Maria
Manuela
Martins
d,
E´lvio
Ru´bio
Gouveia
e,
Duarte
Luı´s
de
Freitas
e,
Jose´ Anto´nio
Maia
f,
Debra
J.
Rose
ga
SaintJosephofClunyHigherSchoolofNursing,Portugal
b
InstituteofBiomedicalSciencesAbelSalazar,UniversityofPorto,Portugal
cHigherSchoolofHealth,UniversityofMadeira,Portugal dHigherSchoolofNursingofPorto,Portugal
e
DepartmentofPhysicalEducationandSports,UniversityofMadeira,Portugal
f
CIFID,FacultyofSport,UniversityofPorto,Portugal
g
DivisionofKinesiologyandHealthScience,CaliforniaStateUniversityFullerton,USA
ARTICLE INFO Articlehistory:
Received14October2014
Receivedinrevisedform8December2015 Accepted11December2015 Keywords: Aged Community-dwelling Rehabilitationnursing Posturalbalance ABSTRACT
Objective:Thisstudyaimstoassesstheeffectofanurse-ledrehabilitationprogramme(the ProBalanceProgramme)onbalanceandfallriskofcommunity-dwellingolderpeoplefrom MadeiraIsland,Portugal.
Design:Single-blind,randomisedcontrolledtrial. Setting:Universitylaboratory.
Participants: Community-dwellingolderpeople, aged 65–85,with balance impair-ments.Participantswererandomlyallocatedtoaninterventiongroup(IG;n=27)ora wait-listcontrolgroup(CG;n=25).
Intervention:A rehabilitation nursing programme included gait, balance, functional training,strengthening, flexibility, and 3D training.One trained rehabilitation nurse administeredthegroup-basedinterventionoveraperiodof12weeks(90minsessions, 2daysperweek).Await-listcontrolgroupwasinstructedtomaintaintheirusualactivities duringthesametimeperiod.
Outcome:BalancewasassessedusingtheFullertonAdvancedBalance(FAB)scale.Thetime pointsforassessmentwereatzero(pre-test),12(post-test),and24weeks(followup). Results:Changesinthemean(SD)FABscalescoresimmediatelyfollowingthe12-week interventionwere5.15(2.81)fortheIGand 1.45(2.80)fortheCG.Atfollow-up,themean (SD)changescoreswere 1.88(1.84)and0.75(2.99)fortheIGandCG,respectively.The resultsofamixedbetween-withinsubjectsanalysisofvariance,controllingforphysical activitylevelsatbaseline,revealedasignificantinteractionbetweengroupandtime(F(2, 42)=27.89, p<0.001, Partial Eta Squared=0.57) and a main effect for time (F (2, 43)=3.76,p=0.03,PartialEtaSquared=0.15),withbothgroupsshowingchangesinthe meanFABscalescoresacrossthethreetimeperiods.Asignificantmaineffectcomparing
* Correspondingauthorat:SaintJosephofClunyHigherSchoolofNursing/EscolaSuperiordeEnfermagemSa˜oJose´ deCluny,RampadeQuintadeSant’ Anan.22,9050-535Funchal,Madeira,Portugal.Tel.:+351291743444/5.
E-mailaddress:[email protected](B.R.Gouveia).
ContentslistsavailableatScienceDirect
International
Journal
of
Nursing
Studies
journalhomepage:www.elsevier.com/ijns
http://dx.doi.org/10.1016/j.ijnurstu.2015.12.004
Whatisalreadyknownaboutthetopic?
Research has shown that some types of exercise are moderately effective in improving clinical balance of olderadults,immediatelyfollowinganintervention. Conflictingevidencestillexistsastothetypeofexercise
andconditionsunderwhichinterventionsareeffective. Whatthispaperadds
Thisoriginalresearcharticledescribesapositiveeffectof a rehabilitation nursinginterventionin improving the multiple dimensions of balance in older adults with balanceimpairments.
1. Background
Oneofthestrongestmodifiableriskfactorsassociated withincreasedfallriskisbalanceimpairment(Deandrea etal.,2010;RubensteinandJosephson,2002;Tinettiand Kumar, 2010). Impaired balance is also an important independentpredictorofthetransitioninstatusfrom non-faller to faller (Muir et al., 2010). Because of this associationbetween balanceimpairmentsand increased risk of falling in older people, the effect of exercise interventions on balance, and specifically the effect of community-basedgroup-structuredexerciseprogrammes, havebeenextensivelystudiedoverthepast20–25years (Rose, 2008). Currently, there is scientific evidencethat some types of exercise, including gait, balance, co-ordination and functional tasks, strengthening exercise, 3Dexerciseand multipleexercisetypes,aremoderately effectiveinimprovingclinicalbalanceoutcomes(Cadore etal.,2013;Howeetal.,2011).Inparticular,theory-driven rehabilitation programmestargeting important intrinsic risk factors associated with increased fall risk, suchas balanceandgaitimpairmentsandmuscleweakness,have proventobeeffectiveinreducingfallriskandimproving balanceamong olderpeople (Rose, 2011;Westlake and Culham,2007).
However,therearestilluncertaintiesrelatedtospecific characteristics of the participants targeted (i.e., balance levelsatbaseline),andthetype,thedosage,thesettingsand thesupervisionneededduringtheintervention(Howeetal., 2011).Therefore,furtherresearchisneededonthistopic.
Fromarehabilitationnursingperspective,early identi-ficationof age-relatedchangesand riskfactorsfor falls, suchasbalanceimpairments,andthedeliveryoftargeted training are essential to prevent older adults from
progressingtomoresevereimpairmentsorexperiencing a serious fall. Therefore, the present research aims to provideevidenceontheeffectofatheory-driven group-basedexerciseintervention(theProBalanceProgramme) in a group of community-dwelling older people with balanceimpairmentsfromMadeiraIsland,Portugal. 2. Methods
2.1. Studydesign
Arandomisedcontrolledtrial(RCT)wasconductedto assesstheeffectoftheProBalanceProgrammeonbalance of community-dwelling older people with balance im-pairment from Madeira Island, Portugal. This RCT was prospectively registered in the Australian New Zealand Clinical Trials Registry Platform and the clinical trial registrationnumberwasACTRN12612000301864. 2.2. Participants
Thesampleconsistedof177community-dwellingmen and women aged 65–85 years old. Participants were recruitedfromMadeiraIsland,Portugal,byadvertisingina regionalnewspaper,posters,flyerswithwritten informa-tion, social networks,and throughpresentations bythe main researcher in religious communities and social institutionsinthecity.
For participation, all volunteers were assessed for eligibility criteria in the project’s laboratory in the University,byatrainedgroupofassessors(sixRegistered NursesandanexpertinthefieldofGerokinesiology,who coordinatedthegroup).Keyinclusioncriteriawere:(1)to be community-dwelling and aged 65–85 years; (2) to present balance impairments compatible with scoring 26to30/40intheFullertonAdvancedBalance(FAB)scale orscoring20to25/40intheFABscale,ifnotreportingfalls inthepastyear;and(3)tobeabletowalkindependently. Exclusion criteria included: (1) cognitive impairment (assessed by the Mini Mental State Test), and (2) any significantco-morbiditiesthatwouldpreclude participa-tion, such as acute illnesses, progressive neurological diseases,stroke,andotherunstablechronicconditions.
The optimal sample size calculation was based on resultsofpreviousresearchandtheresultsofanearlier pilotstudy(4-weekdurationMini-RCT),usingG*Power3 (Faul et al., 2007). A priori, repeated-measures ANOVA indicated that a totalsample size of48 wasneededto achieve95%powertodetectaninteractioneffectsizeof thetwogroups(F(1,43)=21.90,p<0.001,PartialEtaSquared=0.34)confirmedaclear positiveeffectoftheinterventionwhencomparedtothecontrol.
Conclusion: This study demonstrated that the rehabilitation nursing programme was effectiveinimprovingbalanceandreducingfallriskinagroupofolderpeoplewithbalance impairment,immediatelyaftertheintervention.Adeclineinbalancewasobservedforthe IGafteraperiodofnointervention.
ClinicalTrialRegistrationNumber: ACTRN12612000301864.
0.25atthe0.05levelofsignificance.Althoughanattrition rateofzerowasfoundinourpilotstudy,apotential8% attritionratewasconsideredforthemainRCTandatotal of52participantsweretargetedinthisstudy.
Asimple randomisationprocesswasusedtoallocate theeligibleparticipantstooneofthetwogroups,defined astheInterventionGroup(IG)ortheControlGroup(CG). Numbers wererandomlyselected to formgroup 1 and group 2, using a random number generator software. Clusters (of two participants) were only used in the randomisation for couples and relatives, in order to preventcontamination.Blindingwasusedinthe genera-tionoftheallocationsequenceandintheassignmentofthe participantstooneofthetwogroups.Thesetaskswere carriedoutbyanindependentperson.
EthicalapprovaloftheProBalanceProjectwasgranted by the Ethics Committee of the Health Service of the Autonomous Region of Madeira. Informed consent was providedbyallparticipantsduringtheenrollmentphase, before anyassessment. Written and verbal information about the study was given to all volunteers. All data collectionandmanagementprocedurestookintoaccount theparticipants’righttoprivacyandconfidentiality.The interventionwasdeliveredtotheCGaftertheendofthe trial.
2.3. ProBalanceintervention
ProBalanceisarehabilitation-nursingprogrammethat includesmultipleexercisetypes(e.g.,balance, co-ordina-tionandfunctionaltaskstraining,gaittraining, strength-eningandflexibilityexercises,and3Dtraining).
Inspired by the FallProof Balance and Mobility Pro-gramme(Rose, 2010), theProBalanceis a theory-driven programme, adopting a multidimensional approach to balanceandmobilityinindependent-livingolderpeople withbalanceimpairments.Itisbasedonacomprehensive approach thesystems that contribute tobalance and it targetsintrinsicriskfactorsassociatedwithincreasedfall risk, such asbalance and gait impairmentsand muscle weakness(Rose,2011).
Thegroup-basedinterventionwasadministeredbya rehabilitationnurse,whowasresponsiblefordelivering all exercise sessions, givinginstructions on each exer-cise, controlling the number of repetitions and the duration of the exercise, as well as, controlling the patient’s reaction to the training. The rehabilitation nurse was a registered clinical nurse specialist with expertise in the field of rehabilitation. Besidesclinical experience, specifictraining on balance-related assess-ment and targeted intervention was accomplished by this nurse priorto the study.In the exercisesessions, there were other members of the intervention team (traineduniversitystudents)thatassistedintheexercise preparation and supervised the older people during exerciseperformance(1:1ratio).
Atotalof24sessionswasdeliveredover12-consecutive weeks(i.e.,90-minduration, 2days perweek)between AprilandJuly2012.Thisoptionwasbasedontheresultsof previousresearch(Howeetal.,2011).Intensityofexercise was low tomoderate and the Borg Rating Scale (Borg,
1982)wasusedtomonitorperceivedexertion.Thesetting wastheproject’slaboratoryattheUniversity.
In the intervention protocol, each exercise session includedsix keyexercisecomponents: (1) multisensory training;addressingthevisual,thesomatosensory,andthe vestibularsystem;(2)centreofgravitycontroltraining;(3) proactiveandreactiveposturalstrategytraining;(4)gait patternenhancementandvariationtraining;(5) strength-eningandenduranceexercise;and(6)flexibilitytraining. Further explanation on the rationale for this type of exercise intervention and a detailed description on the exercises have been described elsewhere (Rose, 2010). Materials such as sunglasses, aiming games (i.e., mini-basketballset,velcrotargetwithballs, softbaseballset), tapeandfloormarks,beanbagsandparachute,lighttray with plastic glasses, large print material (with familiar images),chairs,woodenbenches(10cmheight),foampads, airpads,resistancebands,weightedballs,balloonsand non-weightedballs(10cmdiameter)wereusedinthetraining. Inrelationtopads,bandsandweightedballs,progressions weredonefrommorestable,lessresistantorlessheavyto lessstable,moreresistantorheaviermaterials.
Aimingtoenhanceadherenceoftheparticipants,two 45-mineducationalsessionsweredeliveredatthe begin-ningandinthemiddleoftheinterventionperiod.These sessions didnot occur in the sameday as theexercise sessions. This educational element addressed general aspectsoffallprevention(riskfactorsandconsequences offallsinolderpeopleandtheimportanceofmotivation andadherencetofall-preventioninterventions).
The feasibility of the intervention protocol was previouslyverifiedinthepilotstudy.
Since theCG wasa wait-list CG, participantsin this group maintained their usual activities during the interventionperiod,anddidnotparticipateinanyspecific balancetraining(asassessedatbaselineandmonitoredby questionnaireineachassessment).
2.4. Outcomemeasures
The primary outcome in this study was balance, assessedusingtheFullertonAdvancedBalance(FAB)scale, abalanceassessmenttoolthatisdesignedtobeusedwhen assessing the functional balance of independent older peopleresidinginthecommunity.Preliminaryresultsof the psychometric evaluation of this scale’s content, its convergentvalidity,test–retest,andintra-andinter-rater reliability, and also internal consistency were first publishedin2006(Roseetal.,2006).Thecontentvalidity wasbasedonresultsfromareviewofliterature,anexpert panelexaminationandfeedback,andpilot-testingofthe originalscalewith15healthyolderparticipants.Although itwasdevelopedtoassesshigherfunctioningolderpeople, convergent validity was obtained by comparing results withtheBergBalanceScale(BBS)assessmentin31 parti-cipants. The results of the Spearman rank correlation analysis indicated a significant (p=0.01) and moderate correlationof0.75betweenthescoresofbothscales.The test–retestreliabilitycoefficientfortheFABscalewas0.96, theinter-rater reliability coefficients for thetotal score rangedfrom0.94to0.97,whiletheintra-raterreliability
rangedfrom0.97to1.00.Thehomogeneitycoefficients(H) were0.75foralltestitems.ARashanalysisofthescalewas also conducted by Klein et al. (2010) in a sample of 480community-dwellingparticipants,aged60yearsand older, who were able to ambulate independently. The reliabilityofthescaletoseparatepersonswas0.81outof 1.00and thereliabilityofthescaletoseparateitemsin termsoftheirdifficultywas0.99outof1.00.ACronbach’s alphavalueof0.81wasestablishedforthetotalFABscale score,confirmingitsgoodinternalconsistency(Kleinetal., 2010).
Thisisaperformance-basedmeasurethat comprehen-sively addresses the multiple dimensions of balance, throughstaticanddynamicbalanceactivitiesperformed indifferentsensoryenvironments,andisconsideredtobe useful for screening and identifying subtle changes in balance abilities, that act as precursor to an increased probability of falling (Hernandez and Rose, 2008). This balanceassessmentcanbeconductedinarelativelysmall area and its administration requires approximately10– 12min.Thescaleiscomprisedof10individualtestitems: (Item1)standingwithfeettogetherandeyesclosed;(Item 2)reachingforwardtoretrieveanobject;(Item3)turning inacircle;(Item4)steppingupandoverabench;(Item5) tandemwalking;(Item6)standingon oneleg;(Item 7) standingonfoamwitheyesclosed;(Item8)jumpingfor distance;(Item9)walkingwithheadturns;and(Item10) recovering froman unexpectedloss of balance. Perfor-manceoneachoftheindividualtestitemsisscoredusinga 5-point ordinal scale (0–4), with a maximum score of 40 points possible, representing an optimal balance performance. Lower scores mean lower balance perfor-manceandhigherprobabilityforfalling(Hernandezand Rose,2008;Roseetal.,2006).
ThesensitivityandspecificityoftheFABscaletopredict thefallerstatus(definedaspersonswithahistoryoftwoor more falls in the previous 12 months) has also been established by Hernandez and Rose (2008). The cut-off scoreof25outof40ontheFABscaleproducedthehighest sensitivity(74.6%)andspecificity(52.6%)inpredictingthe recurrentfaller status, allowingtodraw theconclusion thatanolderadultwhoscores25orlowerontheFABscale isconsideredtobeatheightenedriskforfallingandinneed ofimmediate intervention. Moreover,the probabilityof fallingincreasedby8%witheach1-pointdecreaseinthe FABscale.
Mean scores and mean change scores for the main outcomewereanalyzedinthisresearch.
Thetimepointsforassessmentwereatzero(pre-test),12 (post-test), and24 weeks(follow up). Participants were assessedbyanindependentassessorwhowasblindedto group assignment. Prior to this RCT, the test–retest reliabilityintheassessmentoftheoutcomemeasurewas establishedinthepilotstudy(12participants,2assessments withina1-weekinterval).Intra-classcorrelationcoefficient (R)was0.885forthemeanFABscalescore.
2.5. Baselineassessments
In this study, baseline characteristics were assessed, namely: (1) demographic characteristics (gender, age,
education);(2)clinicalcharacteristics(numberoffallsand numberofmedications);(3)cognition[Mini-MentalState Test(Folsteinetal.,1975;PortugueseversionbyGuerreiro etal.,1994)];(4)balance[FABscale(Roseetal.,2006)];(5) gait velocity, derived fromthe 30-foot walk test (Rose, 2010);(6)fearoffalling[FallsEfficacyScale(Tinettietal., 1990;PortugueseversionbyMelo,2011)];(7)functional fitness components [chair stand and arm curl, sit and reach,and6-minutewalktests(RikliandJones,2001)];(8) physical activity level [Modified Baecke questionnaire (Voorrips et al., 1991; Portuguese version by Azevedo, 2009)]; (9) health-related quality of life (HRQL) [SF36 (Ware and Sherbourne, 1992; Portuguese version by
Ribeiro, 2005)]. In addition tovalidating all assessment protocolsinthepilotstudy,thetest–retestreliabilityofall measureswasalsoverified.Intra-classcorrelation coeffi-cients(R)rangedbetween0.689and0.987.
2.6. Statisticalanalysis
Statisticalanalysesincludeddescriptivestatisticsanda mixed-ANOVA (between groups within subjects). This mixedbetween-withinsubjectsanalysisofvariancewas conductedtoassesstheimpactoftheintervention/control onparticipants’totalscoresontheFABScale,andacross the threetime periods(pre-test, post-testand 12-week follow-up).Physicalactivityatbaseline wasincludedas covariateinthemodel,duetoitsconfoundingpart.Data analysisassumptionswereverified.Thelevelofconfidence wassetat95%.DatawereanalyzedusingtheIBMSPSS statistics20computerpackage(IBMCorp.Released,2011).
Aperprotocolanalysiswasconducted. 3. Results
Advertisements startedin January 2012.Recruitment startedinMarch2012andwascompletedinApril2012.A total of 177 older adults were assessed for potential enrollment. Of these, only52 older adults were eligible andrandomlyallocatedtotheIG(n=27)ortothewait-list controlgroup(CG),whomaintainedtheirusualactivities (n=25).Atotalof46participantscompletedthestudy(IG; n=26; CG; n=20). The intervention protocol was fully applied during the course of the study, as planned. Adherencefortheparticipantswhocompletedthestudy, assessedbytheproportionofsessionsattended,was100%. Noadverseevents(i.e.,falls)orsideeffectswereassociated withtheexerciseinterventionortheassessments.However, othereventsledtoattrition,asdescribedinFig.1.
Througha simplerandomisationprocess,twogroups with similar characteristics were formed. Participants’ characteristicsatbaselinearesummarisedinTable1. 3.1. Effectoftheintervention
Descriptive statistics for mean FAB Scale scores at baselineand immediatelyfollowingtheinterventionare presentedinTable2.After12weeks(post-test),thechange scoresinthemeanFABscalewere5.15pointsfortheIG and 1.45pointsfor theCG,reaching statistical signifi-cance. Considering thepredictive propertiesof theFAB
scaledescribedbyHernandezandRose(2008),whoreport thattheprobabilityoffallingincreasedby8%witheach 1-pointdecreaseintheFABscale;thechangescoreafterthe 12-weekinterventionfortheCGcouldbeassociatedwith anincreaseintheprobabilityoffalling.
Allparticipantswereassessedagain12weeksafterthe completion of the intervention (detraining period). De-scriptiveresultsrelatedtothefollowuparepresentedin
Table3.ThemeanFABscalechangescoreswere 1.88and 0.75points,forIGandCG,respectively.Inboth,CGandIG, changesreachedstatisticalsignificance.Again, themean changescoreintheIGcouldrepresentanincreaseinthe probabilityoffalling.
3.2. Effectsizeestimates
Amixedbetween-withinsubjectsanalysisofvariance was conductedtoassessthe impact ofthe intervention/ controlonparticipants’scoresontheFABscale,acrossthe threetimeperiods(pre-test,post-test,and12-week follow-up),controllingforphysicalactivitylevelatbaseline.
This analysis revealeda significant interactioneffect (Wilk’sLambda=0.43,F(2,42)=28.89,p<0.001,Partial EtaSquared=0.57).Therewasalsoastatisticallysignificant
maineffectfortime(Wilk’sLambda=0.85,F(2,42)=3.76, p=0.03, Partial Eta Squared=0.15), with both groups showingchangesinthemeanFABscalescoresacrossthe threetimeperiods.However,therewasasignificantmain effect for group (F (1, 43)=21.90, p<0.001, Partial Eta Squared=0.34),showingthattheIGrevealedasignificant improvementinbalanceperformancewhencomparedto theCG.Inaddition,accordingtotheguidelinesproposedby
Cohen(1988),theresultsdemonstratedaverylargeeffect size(PartialEtaSquared=0.34).Theinterpretationofthe effectsidentifiedissupportedbythegraphicrepresentation oftheresultsforthemeanFABscalescoresseeninFig.2. 4. Discussion
Thegeneralaimofthisstudywastoexaminetheeffect oftheProBalanceprogramme,usingaclinicalmeasureof balanceincommunity-dwellingolderpeople.Twosimilar groups wereevaluatedin this RCT. Thegroupthat was randomlyallocatedtothe12-weekinterventionshowed significantgainsinbalanceaftertheintervention,when comparedtotheirpeersthatwererandomlyallocatedto theCG.Aftertheintervention(post-test),themeanFAB scalescoreincreasedby5.15pointsintheIG,whilethere Assessed for eligibility (n=177)
Excluded (n=125) • Not meeting inclusion
criteria (n=108) • Declined to participate
(n=9)
• Other reasons (n=8)
Completed the 24-week assessment/ Analyzed (n=26)
Excluded from analysis (n=0) Lost to follow-up (1 ill) (n=1) Discontinued intervention (n=0) Allocated to intervention (n=27)
• Received allocated intervention (n=27) • Did not receive allocated intervention
(n=0)
Lost to follow-up (2 Fall-injured, 1 ill) (n=2)
Discontinued usual care (1 Died, 1 ill, 1 lost interest)(n=3)
Allocated to control (n=25) • Received usual care (n=25) • Did not receive usual care (n=0)
Completed the 24-week assessment/ Analyzed (n=20)
Excluded from analysis (n=0)
Allocation
Analysis Follow-Up
Randomized (n=52)
Enrollment
wasadecreaseof1.45pointsintheCG.Atfollowup,the meanchangescoreswere 1.88and0.75points,forIGand CG,respectively.AlthoughthemeanFABscalescorewas slightlylowerfortheIGatfollow-up(30.85),themeanFAB scoreremainedhigherthan atthebaseline (27.58)(see
Table2andTable3).Overall,bothgroupsshowedchanges in the FAB scale scores across the three time periods; neverthelessoppositeresultswerefoundfortheIGandCG, whichisexplainedbythesignificantinteractionbetween groupandtime,thesignificantmaineffectfortime,andthe significantmaineffectforgroup.
Similarly,WestlakeandCulham(2007),ina random-ised controlled trial aimed to assess the effect of an 8-weektheory-drivenexerciseinterventionbasedonthe FallProofProgramme,foundpost-intervention improve-mentsinthetotalFABscalescore(a4-pointincreasefor theIGanda1-pointincreasefortheCG,whichreceived education only). Contrary toour results, Westlakeand Culham (2007) reported the maintenanceof FAB scale scores by theparticipantsin theIGat followup. With regardtotheincreaseinthetotalFABscalescoreinthe CG atfollow-up,asimilarfindingwasalsoreportedby Table1
Participants’characteristicsatbaseline:sociodemographic,clinical,cognition,balance,functionalfitness,physicalactivityand health-relatedqualityoflife.
Variables CG(n=20) IG(n=26) Sociodemographic Femalen 22(88%) 24(89%) Ageinyears(SD) 74.06(4.60) 73.15(4.57) Educationinyears(SD) 4.05(2.52) 4.15(2.29) Clinical Numberofmedicationsn(SD) 5.50(3.02) 5.81(2.55)
Numberoffallsinthepastyearn(SD) 0.45(0.60) 0.54(0.86)
Cognition
Mini-MentalStatescore(SD) 26.45(3.10) 27.38(2.25)
Balance
TotalFABscalescore(SD) 26.95(2.67) 27.58(2.77)
Gaitvelocityatthepreferredspeedinm/s(SD) 1.16(0.25) 1.28(0.17)
Gaitvelocityatthemaximumspeedinm/s(SD) 1.53(0.34) 1.67(0.21)
FallsEfficacyScalescore(SD) 86.90(18.35) 90.88(10.75)
Functionalfitness
Chairstandtestn(SD) 13.05(3.28) 13.62(2.70)
Armcurltestn(SD) 15.00(3.49) 16.08(3.64)
6-minutewalktestinm(SD) 455.36(97.72) 490.62(65.73)
Physicalactivity
Householdscore(SD) 1.74(0.29) 1.89(0.45)
Sportsscore(SD) 1.33(1.48) 1.07(1.97)
Leisuretimescore(SD) 2.32(2.78) 5.28(4.41)
Totalscore(SD) 5.38(2.50) 8.24(4.92)
Health-relatedqualityoflife
SF-36physicalcomponentscore(SD) 190.71(56.69) 220.76(62.47)
SF-36mentalcomponentscore(SD) 211.25(76.86) 231.43(103.65)
SF-36totalscore(SD) 401.96(115.73) 452.19(151.48)
CG,controlgroup;IG,interventiongroup;FAB,FullertonAdvancedBalance.
Table3
Findingsontheoutcomemeasureatpost-testandfollow-upbygroup:controlandintervention.
Variable Controlgroup(n=20) Interventiongroup(n=26)
Post-test Followup Dscore p Post-test Followup Dscore p
MeanFABscale score(SD)
25.50(3.36) 26.25(3.89) 0.75(2.99) 0.276 32.73(2.11) 30.85(3.18) 1.88(1.84) <0.0001
FAB,FullertonAdvancedBalance(possiblescorerange:0–40);Dscore,changebetweenpost-testandfollowup. Table2
Findingsontheoutcomemeasureatbaselineandaftertheinterventionbygroup:controlandintervention.
Variable Controlgroup(n=20) Interventiongroup(n=26)
Pre-test Post-test Dscore p Pre-test Post-test Dscore p
MeanFABscale score(SD)
26.95(2.67) 25.50(3.36) 1.45(2.80) 0.032 27.58(2.77) 32.73(2.11) 5.15(2.81) <0.0001
Westlake and Culham (2007) after the intervention period. A possible explanation for these results could bethe trainingeffect after repeated assessmentsusing theFABscale,aswellas,anincreasedawarenessamong theparticipantsintheCGinrelationtobalanceandfall prevention.
Althoughdifferentmeasuresofbalancewereusedas outcome measuresin the majorityof randomised trials reviewed,multipleexercisetypeinterventionshavebeen showntobeassociatedwithsignificantimprovementsin othercompositemeasuresofbalance(Howeetal.,2011). Changescoreof17.80fortheIG(n=21)and0.40fortheCG (n=23)intheBBSwerefoundbyWormetal.(2001),after a12-weekintervention.Otherstudies,alsousingtheBBS as an outcome measure, reported significant improve-mentsinmeandifferencesbetweencontroland interven-tionimmediatelyaftertheintervention(Beyeretal.,2007; BierylaandDold,2013;SykesandLing,2004). Notwith-standingusingotheroutcomemeasures,othertrialshave also found similar findings as results of the different exerciseinterventions(Bateni,2012;Kaesleretal.,2007; Nitzetal.,2010).
Anotherinterestingfindingofthisstudywasthatinthe IGthemeanFABscalescoreincreasedandmovedaway from thecut-off point of 25, whichis predictive ofthe recurrentfallerstatus.Ontheotherhand,after12weeks, participantsintheCGcontinuedtoobtainFABscalescores equaltoorlowerthan25points,whichcanbeassociated to a heightened risk for falling and to the need for immediateintervention(HernandezandRose,2008).
Thestatisticalsignificanceoftheeffectofthe interven-tion demonstrated responsiveness to training in the participantsintheIG.Adeclineinbalancewasobserved, however,fortheIGfollowingaperiodofnointervention, suggesting that additional or continuous intervention couldbe necessaryto maintainorimprove thebalance performance of the older adults. Therefore, the current studyaddsevidencetosupporttheconclusionstatedby
Howeetal.(2011),thatpositivebalanceeffectswereonly
evident while engaging in the intervention. Another valuablefindingisthat,althoughtheFABscalescorefor theIGdeclinedatfollowup,themeanFABscalescoredid notreturntothebaselinevalue.Thesefindingshighlight the clinical significance of the effect of the ProBalance intervention,namelythroughitscontributiontoreducing fallrisk.
4.1. Strengths
Thereispreviousevidencethatexerciseinterventions canimprovebalanceincommunity-dwellingolderpeople. Yet,moststudiesonthistopichavetargetedhealthyolder peopleand nobalancescreeninghasbeenperformedat baseline. In addition, most trials reflected inadequate reporting of methods (Howe et al., 2011). The present report of the ProBalance randomised controlled trial, provides further evidence for the positive effects of group-basedexerciseinterventions targetinga groupof community-dwellingolderpeople, withbalance impair-mentsidentifiedatbaseline.Fromarehabilitationnursing perspective,early identificationof balance impairments andthedeliveryofspecificbalancetrainingareimportant preventive interventions, since many older adults only seekhealthprofessionaladvicewhenfallsandserious fall-relatedinjurieshappen.Therefore,thistypeofapproachto balanceabilitiesmaypreventcommunity-dwellingolder peoplefromprogressingtomoresevereimpairmentsor experiencingaseriousfall(Yangetal.,2012).
Moreover,thepresentstudyaimedtorespond tothe need for research on theory-driven rehabilitation pro-grammesthatfocusonmanipulatingindividual,task,and environmentalconstraintsconcurrently,assuggestedby
Rose and Clark (2000), handling challenge in order to improve theindividual’s balance abilities when impair-mentsinbalanceareidentified.
One additional highlight of our study was the high adherencerate(100%)demonstratedbytheIGparticipants whocompletedtheintervention.Thismaybeindicativeof thehighacceptabilityandmotivationoftheparticipants, relatedtothistypeofintervention.
Lastly,sincethepresentresearchfocusedonassessing balanceinindependentcommunity-dwellingolderpeople, theFABscalewaschosenasthemainoutcomemeasure, duetoitshighsensitivityindetectingsubtlechangesin balance abilities in community-dwelling older people. Besidesit is a relatively newmultidimensional balance assessment tool, it was designed to assess balance of higherfunctioningolderpeople,hasbeenshowntohave goodpsychometricproperties,doesnotrequireexpensive equipmentandiseasilyreproducedincommunitysettings (HernandezandRose,2008;Kleinetal.,2010;Roseetal., 2006).
4.2. Limitations
Two limitations of this study should be addressed. First,participantswerevolunteerswhorespondedtoour advertisements,whichmaylimitthegeneralizabilityof thestudy’sfindingstothewiderpopulation.Secondly,the using of 1:1 ratio of assistant to participation in this Fig.2.Graphicrepresentationoftheresultsfromthemixed
between-withinsubjectsanalysisofvariance(grouptime,withphysicalactivity ascovariate),showingthechangeinFABscalemeanscoresovertimefor theIGandtheCG.
group-basedexerciseprogrammemaylimititsuseinthe clinicalsettings,duetotheneedofadditionalpersonnel. 4.3. Overallevidenceandimplications
In conclusion, this research demonstrated that the ProBalanceexerciseprogrammewaseffectivein improv-ing balance in a sample of older people with balance impairments,immediatelyaftertheintervention.Thelarge effectsizeidentifiedsuggeststhattheimprovementscould bedirectlyattributedtotheintervention.No harmwas identified.However,theprogramme’slong-termefficacy, itseffectivenessin‘‘realworld’’ clinicalsettings,andits cost-effectivenessremaintobeevaluated.Futureresearch shouldfocusonlongterm-efficacyandincludepragmatic trialstoassesstheeffectivenessandcost-effectivenessof thisinterventionin‘‘realworld’’clinicalsettings. Acknowledgements
The authors would like to thank the mentioned institutions for the funding provided and also the ProBalanceassessment and interventionteamsfor their contributiontotheproject.Weareespeciallygratefulto the olderpeople who tookpart in this study for their participationandinterest.
Conflictofinterest:Nonedeclared.
Funding: Supported by ARDITI – Regional Agency for the DevelopmentofResearch,TechnologyandInnovation(PhD Grantno.1236/1973).SupportedbytheUniversityof Ma-deira in the establishment of the ProBalance laboratory. Supported through the first author’s involvement in the European Science Foundation Research Networking Pro-gramme‘REFLECTION’ –09-RNP-049.Theviewsexpressed are thoseofthe authorsandnot necessarily thoseof the EuropeanScienceFoundation.
Ethical approval:This trial was approved by the Madeira RegionalHealthService’sEthicsCommittee(N.6/2011). References
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