Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil)

BMC Geriatrics

Sérgio Márcio Pacheco Paschoal²  Wilson Jacob Filho³  Cathie Sherrington¹  Anne Tiedemann¹  Celisa Tiemi Nakagawa Sera⁴  Francine de Cristo Stein²  Aline Thomaz Soares²  Monica Rodrigues Perracini¹  Kelem de Negreiros Cabral² 

[1] Musculoskeletal Division, The George Institute for Global Health, The University of Sydney, Sydney, Australia;Department of Internal Medicine, Geriatrics Division, Hospital das Clínicas, Faculty of Medicine, Universidade de São Paulo, São Paulo, Brazil;Geriatrics Discipline, Faculty of Medicine, Universidade de São Paulo, São Paulo, Brazil;Department of Physiotherapy, Speech-Language and Hearing Science and Occupational Therapy, Faculty of Medicine, Universidade de São Paulo, São Paulo, Brazil

关键词: Education;    Exercise;    Aged;    Clinical trial;    Accidental falls;   

Others  :  857823
DOI  :  10.1186/1471-2318-13-27

 received in 2013-01-07, accepted in 2013-02-25,  发布年份 2013

【 摘 要 】

Background

Falling in older age is a major public health concern due to its costly and disabling consequences. However very few randomised controlled trials (RCTs) have been conducted in developing countries, in which population ageing is expected to be particularly substantial in coming years. This article describes the design of an RCT to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in community-dwelling older people.

Methods/design

Multicentre parallel-group RCT involving 612 community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo, Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will undergo a fall risk factor assessment and be referred to their clinicians with the risk assessment report so that individual modifiable risk factors can be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Falls Prevention Program consisting of: an individualised medical management of modifiable risk factors, a group-based, supervised balance training exercise program plus an unsupervised home-based exercise program, an educational/behavioral intervention. Both groups will receive a leaflet containing general information about fall prevention strategies. Primary outcome measures will be the rate of falls and the proportion of fallers recorded by monthly falls diaries and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, fall-related health services use and independence with daily tasks. Data will be analysed using the intention-to-treat principle.The incidence of falls in the intervention and control groups will be calculated and compared using negative binomial regression analysis.

Discussion

This study is the first trial to be conducted in Brazil to evaluate the effectiveness of an intervention to prevent falls. If proven to reduce falls this study has the potential to benefit older adults and assist health care practitioners and policy makers to implement and promote effective falls prevention interventions.

Trial registration

ClinicalTrials.gov (NCT01698580)

【 授权许可】

   
2013 de Negreiros Cabral et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Schmidt MI, Duncan BB, Azevedo e Silva G, Menezes AM, Monteiro CA, Barreto SM, Chor D, Menezes PR: Chronic non-communicable diseases in Brazil: burden and current challenges. Lancet 2011, 377(9781):1949-1961.
• [2]Beaglehole R, Bonita R, Alleyne G, Horton R, Li L, Lincoln P, Mbanya JC, McKee M, Moodie R, Nishtar S: UN high-level meeting on Non-communicable diseases: addressing four questions. Lancet 2011, 378(9789):449-455.
• [3]Gates S, Fisher JD, Cooke MW, Carter YH, Lamb SE: Multifactorial assessment and targeted intervention for preventing falls and injuries among older people in community and emergency care settings: systematic review and meta-analysis. BMJ 2008, 336(7636):130-133.
• [4]Tinetti ME, Kumar C: The patient who falls: “It’s always a trade-off”. JAMA 2010, 303(3):258-266.
• [5]Rubenstein LZ, Josephson KR: The epidemiology of falls and syncope. Clin Geriatr Med 2002, 18(2):141-158.
• [6]Sattin RW: Falls among older persons: a public health perspective. Annu Rev Public Health 1992, 13:489-508.
• [7]Costello E, Edelstein JE: Update on falls prevention for community-dwelling older adults: review of single and multifactorial intervention programs. J Rehabil Res Dev 2008, 45(8):1135-1152.
• [8]Perracini MR, Ramos LR: [Fall-related factors in a cohort of elderly community residents]. Rev Saude Publica 2002, 36(6):709-716.
• [9]Cruz DT, Ribeiro LC, Vieira MD, Teixeira MT, Bastos RR, Leite IC: Prevalence of falls and associated factors in elderly individuals. Rev Saude Publica 2012, 46(1):138-146.
• [10]Centers for Disease Control and Prevention: Fatalities and injuries from falls among older adults--United States, 1993–2003 and 2001–2005. MMWR Morb Mortal Wkly Rep 2006, 55(45):1221-1224.
• [11]Roudsari BS, Ebel BE, Corso PS, Molinari NA, Koepsell TD: The acute medical care costs of fall-related injuries among the U.S. older adults. Injury 2005, 36(11):1316-1322.
• [12]Gawryszewski VPMR, Bandeira de Sa NN, Mascarenhas MDM, Silva MMA, Bernal R: Acidentes e Violencia no Brasil: um panorama atual das mortes, internações hospitalares e atendimentos em servicos de urgência. In Ministerio da Saúde (BR), Secretaria de Vigilancia em Saude. Brasilia, DF: Misterio da Saude; 2010:137-173.
• [13]Malta DC, Silva MM, Mascarenhas MD, Sa NN, Morais Neto OL, Bernal RT, Monteiro RA, Andrade SS, Gawryszewski VP: The characteristics and factors of emergency service visits for falls. Rev Saude Publica 2012, 46(1):128-137.
• [14]Deandrea S, Lucenteforte E, Bravi F, Foschi R, La Vecchia C, Negri E: Risk factors for falls in community-dwelling older people: a systematic review and meta-analysis. Epidemiology 2010, 21(5):658-668.
• [15]Moreland J, Richardson J, Chan DH, O’Neill J, Bellissimo A, Grum RM, Shanks L: Evidence-based guidelines for the secondary prevention of falls in older adults. Gerontology 2003, 49(2):93-116.
• [16]Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons: Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc 2011, 59(1):148-157.
• [17]Rubenstein LZ, Powers CM, MacLean CH: Quality indicators for the management and prevention of falls and mobility problems in vulnerable elders. Ann Intern Med 2001, 135(8 Pt 2):686-693.
• [18]Nevitt MC, Cummings SR, Hudes ES: Risk factors for injurious falls: a prospective study. J Gerontol 1991, 46(5):M164-M170.
• [19]Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH: Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev 2009., 2CD007146
• [20]Bunout D, Barrera G, Avendano M, de la Maza P, Gattas V, Leiva L, Hirsch S: Results of a community-based weight-bearing resistance training programme for healthy Chilean elderly subjects. Age Ageing 2005, 34(1):80-83.
• [21]Woo J, Hong A, Lau E, Lynn H: A randomised controlled trial of Tai Chi and resistance exercise on bone health, muscle strength and balance in community-living elderly people. Age Ageing 2007, 36(3):262-268.
• [22]Assantachai P, Chatthanawaree W, Thamlikitkul V, Praditsuwan R, Pisalsarakij D: Strategy to prevent falls in the Thai elderly: a controlled study integrated health research program for the Thai elderly. J Med Assoc Thai 2002, 85(2):215-222.
• [23]Jitapunkul S: A randomised controlled trial of regular surveillance in Thai elderly using a simple questionnaire administered by non-professional personnel. J Med Assoc Thai 1998, 81(5):352-356.
• [24]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.
• [25]Spice CL, Morotti W, George S, Dent TH, Rose J, Harris S, Gordon CJ: The Winchester falls project: a randomised controlled trial of secondary prevention of falls in older people. Age Ageing 2009, 38(1):33-40.
• [26]Lamb SE, Jorstad-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.
• [27]Sherrington C, Lord SR, Vogler CM, Close JC, Howard K, Dean CM, Clemson L, Barraclough E, Ramsay E, O’Rourke SD: Minimising disability and falls in older people through a post-hospital exercise program: a protocol for a randomised controlled trial and economic evaluation. BMC Geriatr 2009, 9:8. BioMed Central Full Text
• [28]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.
• [29]Camargos FF, Dias RC, Dias JM, Freire MT: Cross-cultural adaptation and evaluation of the psychometric properties of the Falls Efficacy Scale-International Among Elderly Brazilians (FES-I-BRAZIL). Rev Bras Fisioter 2010, 14(3):237-243.
• [30]Logan PA, Coupland CA, Gladman JR, Sahota O, Stoner-Hobbs V, Robertson K, Tomlinson V, Ward M, Sach T, Avery AJ: Community falls prevention for people who call an emergency ambulance after a fall: randomised controlled trial. BMJ 2010, 340:c2102.
• [31]Berg KO, Wood-Dauphinee SL, Williams JI, Maki B: Measuring balance in the elderly: validation of an instrument. Can J Public Health 1992, 83(Suppl 2):S7-S11.
• [32]Miyamoto ST, Lombardi Junior I, Berg KO, Ramos LR, Natour J: Brazilian version of the Berg balance scale. Braz J Med Biol Res 2004, 37(9):1411-1421.
• [33]Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB: A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 1994, 49(2):M85-M94.
• [34]Lord SR, Murray SM, Chapman K, Munro B, Tiedemann A: Sit-to-stand performance depends on sensation, speed, balance, and psychological status in addition to strength in older people. J Gerontol A Biol Sci Med Sci 2002, 57(8):M539-M543.
• [35]Crosby CA, Wehbe MA, Mawr B: Hand strength: normative values. J Hand Surg Am 1994, 19(4):665-670.
• [36]Marsh AP, Rejeski WJ, Espeland MA, Miller ME, Church TS, Fielding RA, Gill TM, Guralnik JM, Newman AB, Pahor M: Muscle strength and BMI as predictors of major mobility disability in the Lifestyle Interventions and Independence for Elders pilot (LIFE-P). J Gerontol A Biol Sci Med Sci 2011, 66(12):1376-1383.
• [37]Tiedemann A, Lord SR, Sherrington C: The development and validation of a brief performance-based fall risk assessment tool for use in primary care. J Gerontol A Biol Sci Med Sci 2010, 65(8):896-903.
• [38]Ramos LR, Toniolo J, Cendoroglo MS, Garcia JT, Najas MS, Perracini M, Paola CR, Santos FC, Bilton T, Ebel SJ: Two-year follow-up study of elderly residents in S. Paulo, Brazil: methodology and preliminary results. Rev Saude Publica 1998, 32(5):397-407.
• [39]Brucki SM, Nitrini R, Caramelli P, Bertolucci PH, Okamoto IH: Suggestions for utilization of the mini-mental state examination in Brazil. Arq Neuropsiquiatr 2003, 61(3B):777-781.
• [40]Paradela EM, Lourenco RA, Veras RP: Validation of geriatric depression scale in a general outpatient clinic. Rev Saude Publica 2005, 39(6):918-923.
• [41]Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO: Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res 1982, 17(1):37-49.
• [42]Lipschitz DA: Screening for nutritional status in the elderly. Prim Care 1994, 21(1):55-67.
• [43]Clemson L, Cumming RG, Kendig H, Swann M, Heard R, Taylor K: The effectiveness of a community-based program for reducing the incidence of falls in the elderly: a randomized trial. J Am Geriatr Soc 2004, 52(9):1487-1494.