A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial

Maria Bjerk, Therese Brovold, Dawn A Skelton, Astrid Bergland, Maria Bjerk, Therese Brovold, Dawn A Skelton, Astrid Bergland

Abstract

Background: Falls and fall-related injuries in older adults are associated with great burdens, both for the individuals, the health care system and the society. Previous research has shown evidence for the efficiency of exercise as falls prevention. An understudied group are older adults receiving home help services, and the effect of a falls prevention programme on health-related quality of life is unclear. The primary aim of this randomised controlled trial is to examine the effect of a falls prevention programme on quality of life, physical function and falls efficacy in older adults receiving home help services. A secondary aim is to explore the mediating factors between falls prevention and health-related quality of life.

Methods: The study is a single-blinded randomised controlled trial. Participants are older adults, aged 67 or older, receiving home help services, who are able to walk with or without walking aids, who have experienced at least one fall during the last 12 months and who have a Mini Mental State Examination of 23 or above. The intervention group receives a programme, based on the Otago Exercise Programme, lasting 12 weeks including home visits and motivational telephone calls. The control group receives usual care. The primary outcome is health-related quality of life (SF-36). Secondary outcomes are leg strength, balance, walking speed, walking habits, activities of daily living, nutritional status and falls efficacy. All measurements are performed at baseline, following intervention at 3 months and at 6 months' follow-up. Sample size, based on the primary outcome, is set to 150 participants randomised into the two arms, including an estimated 15-20% drop out. Participants are recruited from six municipalities in Norway.

Discussion: This trial will generate new knowledge on the effects of an exercise falls prevention programme among older fallers receiving home help services. This knowledge will be useful for clinicians, for health managers in the primary health care service and for policy makers.

Trial registration: ClinicalTrials.gov . NCT02374307 . First registration, 16/02/2015.

Keywords: Balance; Elderly; Exercise; Falls prevention; Home help services; Older adults; Preventative care; Quality of life.

Conflict of interest statement

Ethics approval and consent to participate

The project proposal has been approved by The Regional Committee for Medical Research Ethics in South Norway (Ref. 2014/2051). Informed consent is obtained from all participants included in the analyses, and the project is conducted according to the WMA Declaration of Helsinki.

Consent for publication

Not applicable

Competing interests

DAS is a Director of Later Life Training Ltd., a UK based non-profit organisation providing training to therapists in the effective delivery of the OEP to older adults.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Planned flow of participants in the study

References

    1. Luthy C, Cedraschi C, Allaz A-F, Herrmann FR, Ludwig C. Health status and quality of life: results from a national survey in a community-dwelling sample of elderly people. Qual Life Res. 2015;24(7):1687–1696. doi: 10.1007/s11136-014-0894-2.
    1. Salkeld G, Ameratunga SN, Cameron I, Cumming R, Easter S, Seymour J, Kurrle S, Quine S, Brown PM. Quality of life related to fear of falling and hip fracture in older women: a time trade off studyCommentary: older people's perspectives on life after hip fractures. BMJ. 2000;320(7231):341–346. doi: 10.1136/bmj.320.7231.341.
    1. Acree LS, Longfors J, Fjeldstad AS, Fjeldstad C, Schank B, Nickel KJ, Montgomery PS, Gardner AW. Physical activity is related to quality of life in older adults. Health Qual Life Outcomes. 2006;4(1):1. doi: 10.1186/1477-7525-4-37.
    1. The WHOQOL Group The World Health Organization quality of life assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998;46(12):1569–1585. doi: 10.1016/S0277-9536(98)00009-4.
    1. Helse- og omsorgsdepartementet. NOU 2011:11. Innovasjon i omsorg. Oslo: Departementenes servicesenter; 2011.
    1. Helse- og omsorgsdepartemente. St. Meld 47. Samhandlingsreformen. Oslo: Departementenes servicesenter; 2009.
    1. Christensen K, Doblhammer G, Rau R, Vaupel JW. Ageing populations: the challenges ahead. Lancet. 2009;374(9696):1196–1208. doi: 10.1016/S0140-6736(09)61460-4.
    1. Elkan R, Blair M, Robinson JJ. Evidence-based practice and health visiting: the need for theoretical underpinnings for evaluation. J Adv Nurs. 2000;31(6):1316–1323. doi: 10.1046/j.1365-2648.2000.01423.x.
    1. Helse- og omsorgstjenesteloven. Lov om kommunale helse- og omsorgstjenester m.m. LOV-2011-06-24-30. 2011.
    1. Meinow B, Kåreholt I, Lagergren M. According to need? Predicting the amount of municipal home help allocated to elderly recipients in an urban area of Sweden. Health Soc Care Community. 2005;13(4):366–377. doi: 10.1111/j.1365-2524.2005.00570.x.
    1. Vikman I. Falls, perceived fall risk and activity curtailment among older people receiving home-help service. Doctoral thesis, Luleå: Luleå University of Technology; 2011.
    1. Helsedirektoratet. Prioriteringer i helsesektoren. Verdigrunnlag, status og utfordringer. Oslo: Helsedirektoratet; 2012.
    1. Vieira ER, Palmer RC, Chaves PH. Prevention of falls in older people living in the community. BMJ. 2016;353:i1419. doi: 10.1136/bmj.i1419.
    1. Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012;(9):Art. No.: CD007146. doi:10.1002/14651858.CD007146.pub3.
    1. Bergland A. Falls suffered by the elderly living at home. Doctoral thesis, Oslo: University of Oslo; 2002.
    1. Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013;75(1):51–61. doi: 10.1016/j.maturitas.2013.02.009.
    1. Vivanti AP, McDonald CK, Palmer MA, Sinnott M. Malnutrition associated with increased risk of frail mechanical falls among older people presenting to an emergency department. Emerg Med Australas. 2009;21(5):386–394. doi: 10.1111/j.1742-6723.2009.01223.x.
    1. Saletti A, Johansson L, Yifter-Lindgren E, Wissing U, Österberg K, Cederholm T. Nutritional status and a 3-year follow-up in elderly receiving support at home. Gerontology. 2005;51(3):192–198. doi: 10.1159/000083993.
    1. Scheffer AC, Schuurmans MJ, Van Dijk N, Van Der Hooft T, De Rooij SE. Fear of falling: measurement strategy, prevalence, risk factors and consequences among older persons. Age Ageing. 2008;37(1):19–24. doi: 10.1093/ageing/afm169.
    1. Hawkins K, Musich S, Ozminkowski RJ, Bai M, Migliori RJ, Yeh CS. The burden of falling on the quality of life of adults with Medicare supplement insurance. J Gerontol Nurs. 2011;37(8):36–47. doi: 10.3928/00989134-20110329-03.
    1. Vaapio SS, Salminen MJ, Ojanlatva A, Kivelä S-L. Quality of life as an outcome of fall prevention interventions among the aged: a systematic review. Eur J Public Health. 2009;19(1):7–15. doi: 10.1093/eurpub/ckn099.
    1. Campbell AJ, Robertson MC. Rethinking individual and community fall prevention strategies: a meta-regression comparing single and multifactorial interventions. Age Ageing. 2007;36(6):656–662. doi: 10.1093/ageing/afm122.
    1. El-Khoury F, Cassou B, Charles MA, Dargent-Molina P. The effect of fall prevention exercise programmes on fall induced injuries in community dwelling older adults: systematic review and meta-analysis of randomised controlled trials. BMJ. 2013;347:f6234.
    1. Petridou ET, Manti EG, Ntinapogias AG, Negri E, Szczerbińska K. What works better for community-dwelling older people at risk to fall? A meta-analysis of multifactorial versus physical exercise-alone interventions. J Aging Health. 2009;21(5):713–729. doi: 10.1177/0898264309338298.
    1. Sherrington C, Whitney JC, Lord SR, Herbert RD, Cumming RG, Close JC. Effective exercise for the prevention of falls: a systematic review and meta-analysis. J Am Geriatr Soc. 2008;56(12):2234–2243. doi: 10.1111/j.1532-5415.2008.02014.x.
    1. Vikman I, Nordlund A, Näslund A, Nyberg L. Incidence and seasonality of falls amongst old people receiving home help services in a municipality in northern Sweden. Int J Circumpolar Health. 2011;70(2):195. doi: 10.3402/ijch.v70i2.17813.
    1. Meyer C, Dow B, Bilney BE, Moore KJ, Bingham AL, Hill KD. Falls in older people receiving in-home informal care across Victoria: influence on care recipients and caregivers. Australas J Ageing. 2012;31(1):6–12. doi: 10.1111/j.1741-6612.2010.00484.x.
    1. Fletcher PC, Hirdes JP. Restriction in activity associated with fear of falling among community-based seniors using home care services. Age Ageing. 2004;33(3):273–279. doi: 10.1093/ageing/afh077.
    1. Hellström Y, Persson G, Hallberg IR. Quality of life and symptoms among older people living at home. J Adv Nurs. 2004;48(6):584–593. doi: 10.1111/j.1365-2648.2004.03247.x.
    1. Markle-Reid M, Browne G, Gafni A, Roberts J, Weir R, Thabane L, Miles M, Vaitonis V, Hecimovich C, Baxter P. The effects and costs of a multifactorial and interdisciplinary team approach to falls prevention for older home care clients ‘at risk’for falling: a randomized controlled trial. Can J Aging. 2010;29(01):139–161. doi: 10.1017/S0714980809990377.
    1. Bonnefoy M, Boutitie F, Mercier C, Gueyffier F, Carre C, Guetemme G, Ravis B, Laville M, Cornu C. Efficacy of a home-based intervention programme on the physical activity level and functional ability of older people using domestic services: a randomised study. J Nutr Health Aging. 2012;16(4):370–377. doi: 10.1007/s12603-011-0352-6.
    1. Chou C-H, Hwang C-L, Wu Y-T. Effect of exercise on physical function, daily living activities, and quality of life in the frail older adults: a meta-analysis. Arch Phys Med Rehabil. 2012;93(2):237–244. doi: 10.1016/j.apmr.2011.08.042.
    1. Gillison FB, Skevington SM, Sato A, Standage M, Evangelidou S. The effects of exercise interventions on quality of life in clinical and healthy populations; a meta-analysis. Soc Sci Med. 2009;68(9):1700–1710. doi: 10.1016/j.socscimed.2009.02.028.
    1. Kelley GA, Kelley KS, Hootman JM, Jones DL. Exercise and health-related quality of life in older community-dwelling adults a meta-analysis of randomized controlled trials. J Appl Gerontol. 2009;28(3):369–394. doi: 10.1177/0733464808327456.
    1. De Vries N, Van Ravensberg C, Hobbelen J, Rikkert MO, Staal J, Nijhuis-van der Sanden M. Effects of physical exercise therapy on mobility, physical functioning, physical activity and quality of life in community-dwelling older adults with impaired mobility, physical disability and/or multi-morbidity: a meta-analysis. Ageing Res Rev. 2012;11(1):136–149. doi: 10.1016/j.arr.2011.11.002.
    1. White SM, Wójcicki TR, McAuley E. Physical activity and quality of life in community dwelling older adults. Health Qual Life Outcomes. 2009;7(1):1. doi: 10.1186/1477-7525-7-10.
    1. McAuley E, Konopack JF, Morris KS, Motl RW, Hu L, Doerksen SE, Rosengren K. Physical activity and functional limitations in older women: influence of self-efficacy. J Gerontol Ser B Psychol Sci Soc Sci. 2006;61(5):P270–P277. doi: 10.1093/geronb/61.5.P270.
    1. Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002;59(10):877–883. doi: 10.1001/archpsyc.59.10.877.
    1. McAuley E, Lox C, Duncan TE: Long-term maintenance of exercise, self-efficacy, and physiological change in older adults. J Gerontol 1993, 48(4):P218-P224.
    1. McAuley E, Jerome GJ, Marquez DX, Elavsky S, Blissmer B. Exercise self-efficacy in older adults: social, affective, and behavioral influences. Ann Behav Med. 2003;25(1):1–7. doi: 10.1207/S15324796ABM2501_01.
    1. Landers DM, SM A. Physical activity and mental health. Hoboken, New Jersey: Wiley; 2007.
    1. Bandura A. Self efficacy: the exercise of control. New York: W.H. Freeman; 1997.
    1. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408–412. doi: 10.1001/jama.1995.03520290060030.
    1. Campbell AJ, Robertson MC. Otago Exercise programme to prevent falls in older adults. Wellington: ACC Thinksafe; 2003.
    1. Robertson MC, Campbell AJ, Gardner MM, Devlin N. Preventing injuries in older people by preventing falls: a meta-analysis of individual-level data. J Am Geriatr Soc. 2002;50(5):905–911. doi: 10.1046/j.1532-5415.2002.50218.x.
    1. Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. Published Online First: October 4, 2016; doi:10.1136/bjsports-2016-096547.
    1. Fletcher PC, Hirdes JP. Risk factors for falling among community-based seniors using home care services. J Gerontol Ser A Biol Med Sci. 2002;57(8):M504–M510. doi: 10.1093/gerona/57.8.M504.
    1. Forkan R, Pumper B, Smyth N, Wirkkala H, Ciol MA, Shumway-Cook A. Exercise adherence following physical therapy intervention in older adults with impaired balance. Phys Ther. 2006;86(3):401–410.
    1. Vaapio S, Salminen M, Vahlberg T, Sjösten N, Isoaho R, Aarnio P, Kivelä S-L. Effects of risk-based multifactorial fall prevention on health-related quality of life among the community-dwelling aged: a randomized controlled trial. Health Qual Life Outcomes. 2007;5(1):1. doi: 10.1186/1477-7525-5-20.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8(1):1. doi: 10.1186/1741-7015-8-18.
    1. Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992;40(9):922–935. doi: 10.1111/j.1532-5415.1992.tb01992.x.
    1. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care. 1992:473–83.
    1. Loge JH, Kaasa S. Short form 36 (SF-36) health survey: normative data from the general Norwegian population. Scand J Public Health. 1998;26(4):250–258. doi: 10.1080/14034949850153347.
    1. The EuroQol Group EuroQol-a new facility for the measurement of health-related quality of life. Health policy. 1990;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Brooks R, Group E EuroQol: the current state of play. Health Policy. 1996;37(1):53–72. doi: 10.1016/0168-8510(96)00822-6.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Qual Life Res. 2011;20(10):1727–1736. doi: 10.1007/s11136-011-9903-x.
    1. Janssen M, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22(7):1717–1727. doi: 10.1007/s11136-012-0322-4.
    1. Berg KO, Maki BE, Williams JI, Holliday PJ, Wood-Dauphinee SL. Clinical and laboratory measures of postural balance in an elderly population. Arch Phys Med Rehabil. 1992;73(11):1073–1080.
    1. Peters DM, Fritz SL, Krotish DE. Assessing the reliability and validity of a shorter walk test compared with the 10-meter walk test for measurements of gait speed in healthy, older adults. J Geriatr Phys Ther. 2013;36(1):24–30. doi: 10.1519/JPT.0b013e318248e20d.
    1. Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999;70(2):113–119. doi: 10.1080/02701367.1999.10608028.
    1. Lawton M, Brody E. Assessment of older people: self-maintaining and instrumental activities of daily living. Nurs Res. 1970;19(3):278. doi: 10.1097/00006199-197005000-00029.
    1. Frändin K, Grimby G, Mellström D, Svanborg A. Walking habits and health-related factors in a 70-year-old population. Gerontology. 1991;37(5):281–288. doi: 10.1159/000213272.
    1. Vellas B, Villars H, Abellan G, Soto M. Overview of the MNA® - its history and challenges. J Nutr Health Aging. 2006;10(6):456.
    1. Rubenstein LZ, Harker JO, Salvà A, Guigoz Y, Vellas B. Screening for undernutrition in geriatric practice developing the short-form mini-nutritional assessment (MNA-SF) J Gerontol Ser A Biol Med Sci. 2001;56(6):M366–M372. doi: 10.1093/gerona/56.6.M366.
    1. Guigoz Y, Jensen G, Thomas D, Vellas B. The mini nutritional assessment (MNA®). Review of the literature - what does it tell us? J Nutr Health Aging. 2006;10(6):466.
    1. Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The falls efficacy scale international (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010;39(2):210–216. doi: 10.1093/ageing/afp225.
    1. Marques-Vieira CMA, Sousa LMM, Severino S, Sousa L, Caldeira S. Cross-cultural validation of the falls efficacy scale international in elderly: systematic literature review. J Clinical Gerontol Geriatr. 2016;7(3):72–76. doi: 10.1016/j.jcgg.2015.12.002.
    1. Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the falls efficacy scale-international (FES-I) Age Ageing. 2005;34(6):614–619. doi: 10.1093/ageing/afi196.
    1. Ory M, Resnick B, Jordan PJ, Coday M, Riebe D, Garber CE, Pruitt L, Bazzarre T. Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ann Behav Med. 2005;29(2):20–28. doi: 10.1207/s15324796abm2902s_5.
    1. Cohen J. A power primer. Psychol Bull. 112(1):155–9.
    1. Brovold T, Skelton DA, Bergland A. Older adults recently discharged from the hospital: effect of aerobic interval exercise on health-related quality of life, physical fitness, and physical activity. J Am Geriatr Soc. 2013;61(9):1580–1585. doi: 10.1111/jgs.12400.
    1. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999;319(7211):670–674. doi: 10.1136/bmj.319.7211.670.
    1. Altman D. Practical statistics for medical research. London: Chapman and Hall; 1991.
    1. Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008;40(3):879–891. doi: 10.3758/BRM.40.3.879.
    1. Senn B, Kirsch M, Sanz C, Karlou C, Tulus K, De Leeuw J, Ringner A. Developing and evaluating complex interventions: the new Medical Research Council guidance. Studies. 2013;59:587–592.
    1. McInnes E, Askie L. Evidence review on older people's views and experiences of falls prevention strategies. Worldviews Evid Based Nurs. 2004;1(1):20–37. doi: 10.1111/j.1741-6787.2004.04013.x.
    1. Lamb SE, Jørstad-Stein EC, Hauer K, Becker C. Development of a common outcome data set for fall injury prevention trials: the prevention of falls network Europe consensus. J Am Geriatr Soc. 2005;53(9):1618–1622. doi: 10.1111/j.1532-5415.2005.53455.x.
    1. Lamb SE, Becker C, Gillespie LD, Smith JL, Finnegan S, Potter R, Pfeiffer K. Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions. Trials. 2011;12(1):1. doi: 10.1186/1745-6215-12-125.
    1. Haywood K, Garratt A, Fitzpatrick R. Quality of life in older people: a structured review of generic self-assessed health instruments. Qual Life Res. 2005;14(7):1651–1668. doi: 10.1007/s11136-005-1743-0.
    1. Vuillemin A, Boini S, Bertrais S, Tessier S, Oppert J-M, Hercberg S, Guillemin F, Briançon S. Leisure time physical activity and health-related quality of life. Prev Med. 2005;41(2):562–569. doi: 10.1016/j.ypmed.2005.01.006.
    1. Heydarnejad S, Dehkordi AH. The effect of an exercise program on the health-quality of life in older adults. Dan Med Bull. 2010;57(4):113–117.
    1. Michie S, Abraham C. Interventions to change health behaviours: evidence-based or evidence-inspired? Psychol Health. 2004;19(1):29–49. doi: 10.1080/0887044031000141199.
    1. Solberg PA. Exercise and well-being among older adults: A self-determination theory perspective. PhD thesis, Norwegian School of Sports Science. 2013.
    1. Dadgari A, Hamid TA, Hakim MN, Mousavi SA, Dadvar L, Mohammadi M, Amerian N. The role of self-efficacy on fear of falls and fall among elderly community dwellers in Shahroud, Iran. Nurs Pract Today. 2016;2(3):112–120.
    1. McAuley E, Blissmer B, Katula J, Duncan TE. Exercise environment, self-efficacy, and affective responses to acute exercise in older adults. Psychol Health. 2000;15(3):341–355. doi: 10.1080/08870440008401997.
    1. Netz Y, Wu M-J, Becker BJ, Tenenbaum G. Physical activity and psychological well-being in advanced age: a meta-analysis of intervention studies. Psychol Aging. 2005;20(2):272. doi: 10.1037/0882-7974.20.2.272.
    1. Standage M, JL D. Motivational responses among older adults in sport and exercise settings. I Weiss MR (red) Dev Sport Exerc Psychol lifespan Perspect. 2004:357–81.
    1. World Health Organization. WHO global report on falls prevention in older age. Geneva: World Health Organization; 2007.
    1. Hektoen LF, Aas E, Lurås H. Cost-effectiveness in fall prevention for older women. Scand J Public Health. 2009;37(6):584–589.

Source: PubMed

3
订阅