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What is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals?: Study protocol for a randomised contr

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Physical inactivity and falls in older people are important public health problems. Health conditions that could be ameliorated with physical activity are particularly common in older people. One in three people aged 65 years and over fall at least
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  STUDY PROTOCOL Open Access What is the effect of a combined physical activityand fall prevention intervention enhanced withhealth coaching and pedometers on older adults ’ physical activity levels and mobility-related goals?:Study protocol for a randomised controlled trial Anne Tiedemann 1,2* , Serene Paul 1,2 , Elisabeth Ramsay 1 , Sandra D O ’ Rourke 1,3 , Kathryn Chamberlain 1 , Catherine Kirkham 1 ,Dafna Merom 4 , Nicola Fairhall 1 , Juliana S Oliveira 1 , Leanne Hassett 1,2 and Catherine Sherrington 1,2 Abstract Background:  Physical inactivity and falls in older people are important public health problems. Health conditionsthat could be ameliorated with physical activity are particularly common in older people. One in three people aged65 years and over fall at least once annually, often resulting in significant injuries and ongoing disability. These problemsneed to be urgently addressed as the population proportion of older people is rapidly rising. This trial aims to establishthe impact of a combined physical activity and fall prevention intervention compared to an advice brochure onobjectively measured physical activity participation and mobility-related goal attainment among people aged 60 +. Methods/design:  A randomised controlled trial involving 130 consenting community-dwelling older people willbe conducted. Participants will be individually randomised to a control group (n = 65) and receive a fall preventionbrochure, or to an intervention group (n = 65) and receive the brochure plus physical activity promotion and fallprevention intervention enhanced with health coaching and a pedometer.Primary outcomes will be objectively measured physical activity and mobility-related goal attainment, measured atboth six and 12 months post randomisation. Secondary outcomes will include: falls, the proportion of people meetingthe physical activity guidelines, quality of life, fear of falling, mood, and mobility limitation. Barriers and enablers tophysical activity participation will be measured 6 months after randomisation.General linear models will be used to assess the effect of group allocation on the continuously-scored primary andsecondary outcome measures, after adjusting for baseline scores. Between-group differences in goal attainment (primaryoutcome) will be analysed with ordinal regression. The number of falls per person-year will be analysed using negativebinomial regression models to estimate the between-group difference in fall rates after one year (secondary outcome).Modified Poisson regression models will compare groups on dichotomous outcome measures. Analyses will bepre-planned, conducted while masked to group allocation and will use an intention-to-treat approach. Discussion:  This trial will address a key gap in evidence regarding physical activity and fall prevention for olderpeople and will evaluate a program that could be directly implemented within Australian health services. Trial registration:  ACTRN12614000016639, 7/01/2014. Keywords:  Physical activity, Exercise, Prevention, Aged, Health coaching, Intervention studies, Accidental falls,Clinical trial, Pedometer * Correspondence: atiedemann@georgeinstitute.org.au 1  The George Institute for Global Health, Sydney, Australia 2  The University of Sydney, Camperdown, AustraliaFull list of author information is available at the end of the article © 2015 Tiedemann et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the srcinal work is properly credited. The Creative Commons Public DomainDedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article,unless otherwise stated.  Tiedemann  et al. BMC Public Health  (2015) 15:477 DOI 10.1186/s12889-015-1380-7  Background Physical inactivity is estimated to cause more than fivemillion deaths worldwide each year as reported in the  Lancet   special issue on physical activity [1]. Physical in-activity is particularly common in older age [2]. Experien-cing a fall in older age is also a significant and commonpublic health issue that can result in substantial injury andongoing disability [3]. At least one third of people aged65 years and over fall once or more annually [4].Systematic reviews show that well-designed, structuredexercise programs are effective in preventing falls incommunity-dwelling older people [5,6]. Exercise is most effective if it challenges balance [6]. However, exerciseinterventions found to be effective for falls prevention[5,6] have not generally been of a high enough dose to ensure participants also meet physical activity recom-mendations and obtain broader health benefits. Further-more, several intervention programs aimed at increasingphysical activity levels among older people have actually increased falls. A trial by Ebrahim et al. [7] involving 165women with a history of recent upper limb fracture foundthat a brisk outdoor walking program significantly in-creased fall rates. Similarly in a large-scale trial (n=1089)conducted by Lawton et al. [8] among women aged 40 – 75 years, physical activity prescription with telephone supportsuccessfully increased physical activity levels but also in-creased falls (p<0.001) and injuries (p=0.03). These re-sults suggest that physical activity programs for olderadults should include fall prevention components.This trial aims to establish the impact of a physical ac-tivity and fall prevention intervention compared to anadvice brochure on older people ’ s physical activity levels,mobility-related goal attainment, fall rates, quality of life,fear of falling, mood and mobility limitation. Methods Trial design We will conduct a randomised controlled trial. The de-sign of the trial is illustrated in Figure 1. This trial hasbeen designed according to the CONsolidated StandardsOf Reporting Trials (CONSORT) statement [9] and is re-ported according to the Standard Protocol Items: Recom-mendations for Interventional Trials (SPIRIT) statement[10] and with reference to the Template for InterventionDescription and Replication (TIDieR) checklist [11]. Participants 130 consenting community-dwelling people aged 60 yearsand over will be randomised to either the interventiongroup (fall prevention advice brochure plus physical activ-ity promotion and fall prevention intervention) or a con-trol group (fall prevention advice brochure only). Peoplewill be eligible for inclusion in the trial if they are aged 60+ years; living at home; regular (weekly) users of theinternet via a computer or tablet device; leave the houseregularly (at least once per week) without physical assist-ance from another person.Potential participants will be excluded from participa-tion if they: are  “ house-bound ”  (not having gone outsidewithout physical assistance from another person in thepast month); have a cognitive impairment (a diagnosis of dementia or a Memory Impairment Screen [12] score of less than 5); have insufficient English language skills tofully participate in the program; have a progressiveneurological disease (e.g., Parkinson ’ s disease); have amedical condition precluding exercise (e.g., unstable car-diac disease); already meet the Australian Physical Activ-ity Guidelines for older adults [13] (operationalised as150 minutes of moderate intensity physical activity perweek, assessed using the Incidental and Planned ExerciseQuestionnaire (IPEQ [14])) and have had a falls risk as-sessment in the past year, since they may already be re-ceiving the fall prevention intervention. If it is unclearwhether a potential participant meets the eligibility cri-teria his/her permission will be sought to discuss thiswith a family member or health care professional (e.g.General Practitioner). Baseline Assessment:Questionnaire, objective physical activity measurement and setting of mobility-related goalsEligibility screeningRecruitmentand consentConcealed randomisation (n=130)Intervention group (n=65):6 month physical activity and fall prevention intervention, including fall risk assessment, Fitbit pedometer and fortnightly heath coaching plus fall prevention advice brochure6 month assessment/ follow-up:Follow-up questionnaire, objective physical activity measurement and assessment of goal attainmentControl group (n=65):Fall prevention advice brochureUsual care12 month assessment/ follow-up:12 x monthly postal fall calendarsFollow-up questionnaire, objective physical activity measurement and assessment of goal attainment Figure 1  Trial design.  Tiedemann  et al. BMC Public Health  (2015) 15:477 Page 2 of 6  Recruitment and randomisation Participants will be recruited in metropolitan Sydney and surrounds, in Australia via community-based news-paper advertisements, local council websites, and news-letters and mailing lists of established organisations forolder people, commencing in January 2014. Allocationto study groups will take place after completion of base-line questionnaires, the assessment of current physicalactivity participation and the setting of mobility-relatedgoals. To ensure allocation concealment, randomisationto groups will be undertaken by an investigator not in- volved in recruitment using a computer generated ran-dom number schedule with randomly permuted blocksizes of between 2 and 6. Intervention group Participants allocated to the intervention group (n= 65)will receive the  “ Staying Active and On Your Feet ”  bookletdeveloped by the NSW Ministry of Health and will receivean intervention aimed at increasing physical activity par-ticipation and reducing risk of falling. It involves adminis-tration of the  QuickScreen  fall risk assessment [15],implementation of tailored fall prevention strategies and aphysical activity plan. Health coaching will be used toidentify barriers and facilitators to physical activity partici-pation, and to provide education and support to assist par-ticipants to achieve their physical activity goals.A pedometer enhanced with a web-interface ( “ fitbit ” ,www.fitbit.com/au) will be provided to all interventiongroup participants to give feedback on the amount of daily physical activity achieved. The  fitbits  will also beprovided as a motivational tool to encourage ongoingphysical activity participation. The intervention will bedelivered during one home visit, lasting approximately two hours, by a health coach with a professional back-ground in physiotherapy. The health coach will also be incontact with intervention participants via telephone oremail every two weeks, for a total period of 6 months, tomonitor and facilitate progress towards physical activity goals and to assist participants to overcome any participa-tion barriers that arise. During the bi-weekly telephonecontact, health coaches will also enquire about the circum-stances of any falls that participants may have experiencedand they will discuss strategies for reducing the risk of fu-ture falls. Intervention participants will also be assisted tofind suitable local exercise opportunities (e.g. Tai Chi, bal-ance and strength training) that will be identified using theNSW Ministry of Health ’ s  Active and Healthy   online data-base (http://www.activeandhealthy.nsw.gov.au/).Participants will be encouraged to wear the pedometerduring waking hours on a daily basis for the whole 6 monthintervention period to record their daily steps and providefeedback and motivation to increase their physical activity participation. The  fitbit   enhanced pedometer is designed towirelessly synchronise with computer software to down-load stored physical activity information. Participants willbe encouraged to synchronise and download their data ona weekly basis or more often if desired. During the home visit to implement the intervention, participants will betaught how to use the  fitbit   device and the associatedinternet based feedback and monitoring technology. Theresearch team will have access to all intervention partici-pants ’  fitbit   data and will monitor individual adherencewith the intervention. If participants have not uploadedtheir  fitbit   data to their computer or internet-connectedtablet device in the past week, during the fortnightly con-tact their health coach will enquire about any problemsencountered with the pedometer and they will encourageparticipant compliance with the intervention protocol.Table 1 summarises the intervention content. Control group The control group (n =65) will receive the same booklet “ Staying Active and On Your Feet ”  and will be advisedto continue their usual activities including any healthservice contact, so control group participants will not bedisadvantaged by being in the study. At the conclusionof the trial, control group participants will be assisted tofind physical activity opportunities in their local areathrough access to the NSW Ministry of Health  Activeand Healthy   website. Outcomes Primary outcomes The four primary outcomes will be: physical activity participation, expressed as mean counts/minute/day,assessed over a 7-day period using a matchbox-sized ac-celerometer (  ActiGraph  GT3X+), measured at both sixand 12 months post-randomisation; and mobility-relatedgoal attainment, assessed using the Goal AttainmentScale (GAS), measured at both six and 12 months post-randomisation [16].  ActiGraph  GT3X+ is the most researched accelerom-eter in the physical activity and public health field overthe last 15 years and has been shown to be a valid in-strument [17]. Participants will be instructed to wear theaccelerometer on the right hip, attached via an adjust-able elastic belt, for 7 consecutive days during wakinghours (except during water-based activities or bathing).Activity counts per second will be collected at a sam-pling frequency of 30Hz and reintegrated to 60-secondepochs for data analysis. The mean counts/minute/day   ActiGraph  measure will be computed as the total countsaccumulated in a valid day divided by the wear time of that day. To be considered as a valid day for analysis,  ActiGraph  wear time must include 10 hours or more.Periods of 90-minutes or more of consecutive zeros (in-dicating non-use) will be considered as non-wear time.  Tiedemann  et al. BMC Public Health  (2015) 15:477 Page 3 of 6  Accelerometer data will be manually checked againstparticipant diaries/calendars to verify wear time and er-roneous data will be excluded prior to analysis. Physicalactivity participation will be assessed at both six and12 months after participant randomisation, and  Acti-Graph  data will be extracted by a research assistant whois unaware of group assignment (i.e. blinded outcomeassessment).Two mobility-related goals will be established at base-line by all participants using the GAS with assistancefrom a research assistant or health coach. Once thegoals are agreed upon the research assistant or healthcoach and participant will then predict the GAS out-comes on a five-point scale ranging from  − 2 to +2,where a score of 0 indicates achievement of the set goal,a score of   − 1 indicates no change from the baseline levelof ability for that goal type,  − 2 indicates worse perform-ance than at baseline and +1 and +2 indicate  ‘ somewhatbetter ’  and  ‘ much better ’  performance than the set goal,respectively.Attainment of the agreed mobility-related goals will beassessed at both six and 12 months after participant ran-domisation by a research assistant who is unaware of group assignment. Secondary outcome measures The secondary outcomes will be: falls, recorded withmonthly postal calendars over a period of 12 months; theproportion of people meeting the physical activity guidelines of 150 minutes per week of moderate to vigor-ous physical activity (MVPA) (intensity defined using theFreedson equation of  ≥ 1952 counts/minute from the  Acti- graph  to permit comparisons with other studies [18] andwe will also examine this outcome using a cut point of 1040 counts/minute which is calibrated to detect MVPA(i.e.,  ≥  3.7 METs) in older adults [19 quality of life,assessed with the EQ-5D [20]; fear of falling, assessedusing the short-form Falls Efficacy Scale International[21]; mood, assessed with the positive subscale of the Posi-tive Affect Scale [22]; mobility limitation, assessed usingthe Late Life Function and Disability Index [23]. All sec-ondary outcomes will be measured at both 6 and12 months after randomisation with the exception of falls,which will only be measured at 12 months after random-isation. The intervention group will also complete a brief survey of barriers and enablers to ongoing physical activity participation at the 6 month time point. Analysis of outcomes Accelerometer data will be analysed using  ActiLife 6  software. Acceptable wear time will be set a priori anddefined as 4 days or more of 10 hours or more per day.General linear models will be used to assess the effect of group allocation on the continuously-scored primary (average physical activity counts per minute) and sec-ondary outcome measures (quality of life, fear of falling,mood, mobility limitation), at both six and 12 monthsafter randomisation, after adjusting for baseline scores. Table 1 Intervention description using the Template for Intervention Description and Replication (TIDieR) checklist 1. Brief name Combined physical activity promotion and fall prevention intervention enhanced with health coaching and pedometers toincrease older adults ’  physical activity levels and mobility-related goals.2. Why Physical inactivity and falls in older people are important public health problems. Health conditions that could be amelioratedwith physical activity are particularly common in older people. One in three people aged 65 years and over fall at least onceannually, often resulting in significant injuries and ongoing disability. These problems need to be urgently addressed as thepopulation proportion of older people is rapidly rising.3. What- materials Participants will receive: •  The  “ Staying Active and On Your Feet ”  fall prevention booklet developed by the NSW Ministry of Health • An assessment of their fall risk factors using the  QuickScreen  fall risk assessment [15] • A pedometer enhanced with a web-interface ("fitbit", www.fitbit.com/au) to give feedback on the amount of daily physicalactivity achieved.4. What- procedures Telephone or email-based health coaching will be used to identify barriers and facilitators to physical activity participation, andto provide education and support to assist participants to reduce their risk of falling and to achieve their physical activity goals.5. Who provided Three health coaches with professional backgrounds in physiotherapy will deliver the intervention.6. How The fall risk assessment and tailored fall prevention and physical activity plan will be delivered during one face to faceinterview. Health coaching will be delivered via telephone or email contact.7. Where The intervention will be delivered to community dwelling people in Sydney and surrounds, Australia.8. When and howmuch The face to face assessment and interview will occur at the beginning of the intervention period and will last forapproximately 2 hours. The telephone-based health coaching will occur after the face to face assessment and interview, onceevery 2 weeks for approximately 20 minutes for a total duration of 6 months.9. Tailoring The fall prevention aspect of the intervention will be tailored to individual need with reference to the fall risk assessmentresults. The physical activity plan will be tailored to participant goals, current physical ability and preferences.  Tiedemann  et al. BMC Public Health  (2015) 15:477 Page 4 of 6  Between-group differences in mobility-related goal at-tainment, at both six and 12 months after randomisa-tion, will be analysed with ordinal regression. To aidinterpretation of the GAS, the scores will also be dichot-omised (goal met versus goal not met), and odds ratioscalculated.The number of falls per person-year will be analysedusing negative binomial regression models to estimatethe between-group difference in fall rates after one year(secondary outcome). Modified Poisson regressionmodels will be used to compare groups on dichotomousoutcome measures (proportion of fallers, proportionmeeting physical activity guidelines). All analyses will bepre-planned, conducted while masked to group alloca-tion and will use an intention-to-treat approach. Sample size justification A total of 130 participants (65 per group) will provide80% power to detect a 15% between-group difference inthe primary physical activity outcome (i.e., a between-group difference of 35 mean counts per minute duringwear time, standard deviation of 91), a dropout rate of 15% and alpha of 5%. The estimates of mean accelerom-eter counts per minute for this calculation were takenfrom the 263 community dwelling USA-based womenaged 65 and older in a large sample of accelerometerdata [24]. We took a conservative approach and esti-mated the proportion of dropouts at 15% although ourprevious trials have had lower dropout rates. These cal-culations were undertaken in Stata 12 using the sampsicommand, assuming a 0.7 correlation between measuresand assuming a post-test between-group comparisonthat adjusted for baseline scores.A sample size of 130 will also provide 80% power todetect a clinically meaningful 20% between-group differ-ence in goal attainment scores. The sample size will alsobe sufficient to detect between-group differences in theorder of 10-15% for the secondary outcome measures. Ethics and dissemination The trial protocol has been approved by the Human Re-search Ethics Committee at The University of Sydney,Sydney, Australia (approval number 2013/789). The re-sults of this trial will be disseminated via peer reviewed journal articles, presentations at international confer-ences and participants newsletters. Discussion This trial is highly significant given the dual importanceof falls and inactivity for individuals and health care sys-tems. Public health recommendations for older adultshighlight the need to engage in a combination of aer-obic, muscle strength, flexibility and balance activities.This trial is the first to offer an integrated strategy thatcan fulfil this goal. Population surveys of older adults in-dicate very low participation in fall prevention balanceexercise [25] with the vast majority engaged in aerobicphysical activity, such as walking, but this has not beendemonstrated to prevent falls [26].Hence, this trial will address a key gap in the currentevidence regarding physical activity and fall preventionfor older people. It will provide a model for an inte-grated falls and physical activity assessment and inter- vention program that could be directly implementedwithin Australian health services. The trial findings willbe disseminated in peer-reviewed journals, and throughscientific and professional conferences. Competing interests  The authors declare that they have no competing interests. Authors ’  contributions  AT   and CS conceived of the study. AT,  CS, and SP   initiated the study designand SP, E R, SDO, KC, CK, JS  and LH helped with implementation.  AT, CS, DMand NF will   conduct the primary statistical analyses. All authors contributedto refinement of the study protocol and approved the final manuscript. Acknowledgements  This work is supported by a research bequest in addition to a MarrickvilleCouncil Community Grant and funding from the NSW Office of Communities, Sport and Recreation Participation and Facility Program.Author C Sherrington receives salary funding from the National Health andMedical Research Council of Australia Fellowships. The funders had no rolein the study design and will not have any role during its execution, analyses,interpretation of the data, or decision to submit results. Author details 1  The George Institute for Global Health, Sydney, Australia.  2  The University of Sydney, Camperdown, Australia.  3 Neuroscience Research Australia, Randwick,Australia.  4 University of Western Sydney, Penrith, Australia. Received: 15 December 2014 Accepted: 8 January 2015 References 1. Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT, et al. Effect of physical inactivity on major non-communicable diseases worldwide: an analysisof burden of disease and life expectancy. Lancet. 2012;380(9838):219 – 29.2. Commonwealth Department of Health. Australia's Physical Activity andSedentary Behaviour Guidelines. Canberra: Australia; 2014.3. Murray CJL, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, et al.Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions,1990 – 2010: a systematic analysis for the Global Burden of Disease Study. Lancet.2013;380:2197 – 223.4. Lord SR, Ward JA, Williams P, Anstey KJ. An epidemiological study of falls inolder community-dwelling women: the Randwick falls and fractures study.Australian J Pub Health. 1993;17(3):240 – 5.5. Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, ClemsonLM, et al: Interventions for preventing falls in older people living in thecommunity. Cochrane Database of Systematic Reviews .  2012. (Issue 9. Art.No.: CD007146. DOI: 10.1002/14651858.CD007146.pub3).6. Sherrington C, Tiedemann A, Fairhall N, Close JCT, Lord SR. Exercise to preventfalls in older adults: an updated meta-analysis and best practice recommendations.NSW Pub Health Bull. 2011;22:78 – 83.7. Ebrahim S, Thompson PW, Baskaran V, Evans K. Randomized placebo-controlledtrial of brisk walking in the prevention of postmenopausal osteoporosis. AgeAgeing. 1997;26:253 – 60.8. Lawton BA, Rose SB, Elley CR, Dowell AC, Fenton A, Moyes SA. Exercise onprescription for women aged 40 – 74 recruited through primary care: twoyear randomised controlled trial. Br Med J. 2008;337:a2509.  Tiedemann  et al. BMC Public Health  (2015) 15:477 Page 5 of 6
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