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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Feasibility of a physical activity programme embedded into the daily lives of older adults living in nursing homes: protocol for a randomised controlled pilot feasibility study

Authors: Eva Barrett, Paddy Gillespie, John Newell, Dympna Casey

Published in: Trials | Issue 1/2018

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Abstract

Background

Older adults living in nursing homes spend the majority of their time inactive. The associated levels of chronic disease place an increasing burden on healthcare systems. Physical activity (PA) interventions delivered through exercise classes may be resource-intensive and require specialist staff. The aim of this study is to explore the feasibility and acceptability of a PA programme embedded into the daily lives of older adults living in nursing homes and to examine the preliminary effects of this on physical mobility and quality of life.

Methods

A randomised controlled pilot feasibility study, including embedded qualitative and economic components will be carried out. Two randomly selected nursing homes will take part in the study; participants (n = 20) in one nursing home will receive a three-month PA intervention and participants (n = 20) in the other will be a usual care control. Nursing home staff will be provided with training and support to monitor participants PA programmes. Feasibility data will be collected on recruitment, randomisation, assessment and intervention procedures. Criteria for progression of the pilot feasibility study to a definitive trial will be specified. The Timed Up and Go test, Nottingham Health Profile, 10-Metre Walk test, the Investigating Choice Experiments for the Preferences of Older People Capability index and the Bangor Goal Setting Interview will be assessed at baseline, three-month and 12-month follow-up. Between-group and within-individual effects will be estimated using appropriate linear mixed models. Semi-structured interviews will be conducted with staff and participants of the intervention group within one month after the intervention to explore the feasibility and acceptability of the programme. A subset of control participants will be interviewed to describe usual care. Economic data will be collected to examine costs of the intervention in comparison with costs in the control group.

Discussion

The findings will facilitate refinement of the PA programme and development of a clear protocol for subsequent evaluation of the PA intervention in a definitive randomised controlled trial.

Trial registration

ClinicalTrials.gov, NCT03484715. Registered on 30 March 2018.
Appendix
Available only for authorised users
Literature
1.
World Health Organization. World report on ageing and health. Geneva: WHO; 2015.
2.
Hallal PC, Andersen LB, Bull FC, Guthold R, Haskell W, Ekelund U. Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet. 2012;380(9838):247–57.CrossRefPubMed
3.
Butler RN, Davis R, Lewis CB, Nelson ME, Strauss E. Physical fitness: benefits of exercise for the older patient. 2. Geriatrics. 1998;53(10):46–62.PubMed
4.
5.
Holthe T, Thorsen K, Josephsson S. Occupational patterns of people with dementia in residential care: an ethnographic study. Scand J Occup Ther. 2007;14(2):96–107.CrossRefPubMed
6.
den Ouden M, Bleijlevens MHC, Meijers JMM, Zwakhalen SMG, Braun SM, Tan FES, et al. Daily (in) activities of nursing home residents in their wards: an observation study. J Am Med Dir Assoc. 2015;16(11):963–8.CrossRefPubMed
7.
Crocker T, Forster A, Young J, Brown L, Ozer S, Smith J. Physical rehabilitation for older people in long-term care. Cochrane Database Syst Rev. 2013;(2) CD004294
8.
Chou CH, Hwang CL, Wu YT. 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;93:237–44.CrossRefPubMed
9.
Forster A, Lambley R, Hardy J, Young J, Smith J, Green J, et al. Rehabilitation for older people in long-term care. Cochrane Database Syst Rev. 2009;(1):CD004294.
10.
Rydwik E, Frandin K, Akner G. Effects of physical training on physical performance in institutionalised elderly patients (70+) with multiple diagnoses. Age Ageing. 2004;33:13–23.CrossRefPubMed
11.
Faber MJ, Bosscher RJ, Chin A, Paw MJ, van Wieringen PC. Effects of exercise programs on falls and mobility in frail and pre-frail older adults: a multicenter randomized controlled trial. Arch Phys Med Rehabil. 2006;87:885–96.CrossRefPubMed
12.
Peri K, Kerse N, Robinson E, Parsons M, Parsons J, Latham N. Does functionally based activity make a difference to health status and mobility? A randomised controlled trial in residential care facilities (the promoting independent living study; PILS). Age Ageing. 2008;37(1):57–63.CrossRefPubMed
13.
Fiatarone M, O’Neill E, Doyle N, Clements K, Roberts S, Kehayias J, et al. The Boston FICSIT study: the effects of resistance training and nutritional supplementation on physical frailty in the oldest old. J Am Geriatr Soc. 1993;41:333–7.CrossRefPubMed
14.
American Association of Retired People, American College of Sports Medicine, American Geriatric Society, Centers for Disease Control and Prevention, National Institute on Aging, Robert Wood Johnson Foundation. National blueprint: increasing physical activity among adults age 50 and older. Princeton, NJ: Robert Wood Johnson Foundation; 2001.
15.
van der Bij AK, Laurant MG, Wensing M. Effectiveness of physical activity interventions for older adults: a review. Am J Prev Med. 2002;22(2):120–33.CrossRefPubMed
16.
Brittle N, Patel S, Wright C, Baral S, Versfeld P, Sackley C. An exploratory cluster randomized controlled trial of group exercise on mobility and depression in care home residents. Clin Rehabil. 2009;23(2):146–54.CrossRefPubMed
17.
Byrne SV. Exercise beliefs in elderly nursing home residents: a cross-sectional, case control study [MSc thesis]. Dublin: Royal College of Surgeons in Ireland; 2016.
18.
19.
Anderson-Bill ES, Winett RA, Wojcik JR. Social cognitive determinants of nutrition and physical activity among web-health users enrolling in an online intervention: the influence of social support, self-efficacy, outcome expectations, and self-regulation. J Med Internet Res. 2011;13(1):28.CrossRef
20.
Noar SM, Chabota M, Zimmerman RS. Applying health behavior theory to multiple behavior change: considerations and approaches. Prev Med. 2008;46(3):275–80.CrossRefPubMed
21.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.CrossRefPubMedPubMedCentral
22.
Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A, King MT. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. JAMA. 2018;319(5):483–94.CrossRefPubMed
23.
Podsiadlo D, Richardson S. The timed “up & go” (a test of basic functional mobility for frail elderly persons). J Am Geriatric Soc. 1991;39:142–8.CrossRef
24.
25.
Black BS, Rabins PV, Sugarman J, Karlawish JH. Seeking assent and respecting dissent in dementia research. Am J Geriatr Psychiatry. 2010;18(1):77–85.CrossRefPubMedPubMedCentral
26.
Clare L, Hindle JV, Jones IR, Thom JM, Nelis SM, Hounsome B, et al. The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial. Trials. 2012;13:115.CrossRefPubMedPubMedCentral
27.
Garmendia M, Dangour A, Albala C, Eguiguren P, Allen E, Uauy R. Adherence to a physical activity intervention among older adults in a post-transitional middle income country: a quantitative and qualitative analysis. J Nutr Health Aging. 2013;17(5):466–71.CrossRefPubMedPubMedCentral
28.
Garber CE, Blissmer B, Deschenes M, Franklin B, Lamonte M, Michael J. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011;43(7):1334–59.CrossRefPubMed
29.
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;25:1–7.CrossRefPubMed
30.
van der Ploeg HP, Merom D, Chau JY, Bittman M, Trost SG, Bauman AE. Advances in population surveillance for physical activity and sedentary behavior: reliability and validity of time use surveys. Am J Epidemiol. 2010;172(10):1199–206.CrossRefPubMed
31.
Sylvia LG, Bernstein EE, Hubbard JL, Keating L, Anderson EJ. A practical guide to measuring physical activity. J Acad Nutr Diet. 2014;114(2):199–208.CrossRefPubMed
32.
Avery KNL, Williamson PR, Gamble C, O’Connell E, Metcalfe C, Davidson P, et al. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017;7:e013537.CrossRefPubMedPubMedCentral
33.
Robinson TN, Wallace JI, Wu DS, Wiktor A, Pointer LF, Pfister SM. Accumulated frailty characteristics predict postoperative discharge institutionalization in the geriatric patient. J Am Coll Surg. 2011;213:37–42.CrossRefPubMedPubMedCentral
34.
Laflamme GY, Rouleau DM, Leduc S, Beaumont E. The timed up & go test is an early predictor of functional outcome after hemiarthroplasty for femoral neck fracture. J Bone Joint Surg Am. 2012;94:1175–9.CrossRefPubMed
35.
Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the timed up & go test. Phys Ther. 2000;80(9):896–903.PubMed
36.
Nordin E, Rosendahl E, Lundin-Olsson L. Timed “up & go” test: reliability in older people dependent in activities of daily living- focus on cognitive state. Phys Ther. 2006;86(5):646–55.PubMed
37.
van Iersel MB, Munneke M, Esselink RA, Benraad CE, Olde Rikkert MG. Gait velocity and the timed-up-and-go test were sensitive to changes in mobility in frail elderly patients. J Clin Epidemiol. 2008;61:186–91.CrossRefPubMed
38.
Hunt SM, McKenna SP, McEwen J, Williams J, Papp E. The Nottingham health profile: subjective health status and medical consultations. Soc Sci Med. 1981;15A:221–9.
39.
Baro E, Ferrer M, Va’zquez O, Miralles R, Pont A, Esperanza A, et al. Using the Nottingham health profile (NHP) among older adult inpatients with varying cognitive function. Qual Life Res. 2006;15:575–85.CrossRefPubMed
40.
Bureau-Chalot F, Novella JL, Jolly D, Ankri J, Guillemin F, Blanchard F. Feasibility, acceptability and internal consistency reliability of the Nottingham health profile in dementia patients. Gerontology. 2002;48(4):220–5.CrossRefPubMed
41.
Parker SG, Peet SM, Jagger C, Farhan M, Castelden CM. Measuring health status in older patients. The SF-36 in practice. Age Ageing. 1998;27(1):13–8.CrossRefPubMed
42.
Kim H, Park I, Lee HJ, Lee O. The reliability and validity of gait speed with different walking pace and distances against general health, physical function, and chronic disease in aged adults. J Exerc Nutr Biochem. 2016;20(3):46–50.CrossRef
43.
Montero-Odasso M, Schapira M, Soriano ER, Varela M, Kaplan R, Camera LA, et al. Gait velocity as a single predictor of adverse events in healthy seniors aged 75 years and older. J Gerontol A Biol Sci Med Sci. 2005;60:1304–9.CrossRefPubMed
44.
Hollman JH, Childs KB, McNeil ML, Mueller AC, Quilter CM, Youdas JW. Number of strides required for reliable measurements of pace, rhythm and variability parameters of gait during normal and dual task walking in older individuals. Gait Posture. 2010;32(1):23–8.CrossRefPubMed
45.
Coast J, Flynn TN, Natarajan L, Sproston K, Lewis J, Louviere JJ, et al. Valuing the ICECAP capability index for older people. Soc Sci Med. 2008;67(5):874–82.CrossRefPubMed
46.
Makai P, Brouwer WB, Koopmanschap MA, Nieboer AP. Capabilities and quality of life in Dutch psycho-geriatric nursing homes: an exploratory study using a proxy version of the ICECAP-O. Qual Life Res. 2012;21:801–12.CrossRefPubMed
47.
Makai P, Beckebans F, van Exel J, Brouwer WB. Quality of life of nursing home residents with dementia: validation of the German version of the ICECAP-O. PLoS One. 2014;9(3):e92016.CrossRefPubMedPubMedCentral
48.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.CrossRefPubMedPubMedCentral
49.
50.
Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009;339:3496.CrossRef
51.
O’Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasib Stud. 2015;1:32.CrossRef
52.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.CrossRef
53.
Grabowski DC, Aschbrenner KA, Rome VF, Bartels SJ. Quality of mental health care for nursing home residents: a literature review. Med Care Res Rev. 2010;67(6):627–56.CrossRefPubMedPubMedCentral
54.
Zermansky AG, Alldred DP, Petty DR, Raynor DK. Striving to recruit: the difficulties of conducting clinical research on elderly care home residents. J R Soc Med. 2007;100(6):258–61.CrossRefPubMedPubMedCentral
Metadata
Title
Feasibility of a physical activity programme embedded into the daily lives of older adults living in nursing homes: protocol for a randomised controlled pilot feasibility study
Authors
Eva Barrett
Paddy Gillespie
John Newell
Dympna Casey
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2848-4

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