Effects of 12-month home-based physiotherapy on duration of living at home and functional capacity among older persons with signs of frailty or with a recent hip fracture - protocol of a randomized controlled trial (HIPFRA study)

Paula Soukkio, Sara Suikkanen, Sanna Kääriä, Hannu Kautiainen, Sarianna Sipilä, Katriina Kukkonen-Harjula, Markku Hupli, Paula Soukkio, Sara Suikkanen, Sanna Kääriä, Hannu Kautiainen, Sarianna Sipilä, Katriina Kukkonen-Harjula, Markku Hupli

Abstract

Background: Health concerns, such as frailty and osteoporotic fractures decrease functional capacity and increase use of health and social care services in the aging population. The ability to continue living at home is dependent on functional capacity, which can be enhanced by rehabilitation. We study the effects of a 12-month home-based physiotherapy program with 12-month follow-up on duration of living at home, functional capacity, and the use of social and health care services among older persons with signs of frailty, or with a recently operated hip fracture.

Methods: This is a non-blinded, parallel group, randomized controlled trial performed in South Karelia Social and Health Care District, Finland (population 131,000). Three hundred community-dwelling older persons with signs of frailty (age ≥ 65) and 300 persons with a recent hip fracture (age ≥ 60) will be recruited. Frailty is screened by FRAIL questionnaire and verified by modified Fried's frailty criteria. Both patient groups will be randomized separately to a physiotherapy and a usual care arm. Individualized, structured and progressive physiotherapy will be carried out for 60 min, twice a week for 12 months at the participant's home. The primary outcome at 24 months is duration of living at home. Our hypothesis is that persons assigned to the physiotherapy arm will live at home for six months longer than those in the usual care arm. Secondary outcomes are functional capacity, frailty status, health-related quality-of-life, falls, use and costs of social and health care services, and mortality. Assessments, among others Short Physical Performance Battery, Functional Independence Measure, Mini Nutritional Assessment, and Mini-Mental State Examination will be performed at the participant's home at baseline, 3, 6, and 12 months. Register data on the use and costs of social and health care services, and mortality will be monitored for 24 months.

Discussion: Our trial will provide new knowledge on the potential of intensive, long-term home-based physiotherapy among older persons at risk for disabilities, to enhance functional capacity and thereby to postpone the need for institutional care, and diminish the use of social and health care services.

Trial registration: ClinicalTrials.gov Identifier: NCT02305433 , Registered Nov 28, 2014.

Keywords: Community-dwelling; Duration of living at home; Frail elderly; Functional capacity; Hip fractures; Home-based physiotherapy; Social and health care services.

Conflict of interest statement

Ethics approval and consent to participate

The HIPFRA study has been evaluated in the Helsinki University Hospital’s (HUS) Coordinating Ethics Committee. The study protocol was approved by the coordinating ethics committee on Nov 14, 2014 (document identification number 253/13/03/00/14). Some minor amendment to the research protocol of HIPFRA study documents was made in spring 2017, and approved by the HUS Coordinating Ethics Committee on March 21, 2017 (HUS/891/2017).

This study will comply with the Declaration of Helsinki and the Finnish legislation on Medical research act (488/1999, changed 295/2004, 794/2010, 143/2015). All participants are given both oral and written information about the study and they sign an informed consent before randomization.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

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

Figures

Fig. 1
Fig. 1
Timetable
Fig. 2
Fig. 2
Flow chart

References

    1. Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, et al. Cardiovascular health study collaborative research group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56:146–156. doi: 10.1093/gerona/56.3.M146.
    1. Morley JE, Vellas B, Abellan van Kan G, Anker SD, Bauer JM, Bernabei R, et al. Frailty concensus: a call to action. J Am Med Dir Assoc. 2013;14:392–397. doi: 10.1016/j.jamda.2013.03.022.
    1. Clegg A, Young J, Illiffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013;381:752–762. doi: 10.1016/S0140-6736(12)62167-9.
    1. Bock JO, Köning HH, Brenner H, Haefeli WE, Quinzler R, Matschinger H, et al. Associations of frailty with health care costs – results of the ESTHER cohort study. BMC Health Serv Res. 2016;16:128. doi: 10.1186/s12913-016-1360-3.
    1. Braithwaite RS, Col NF, Wong JB. Estimating hip fracture morbidity, mortality and costs. J Am Geriatr Soc. 2003;51:364–370. doi: 10.1046/j.1532-5415.2003.51110.x.
    1. Marks R. Hip fracture epidemiological trends, outcomes, and risk factors, 1970-2009. Int J Gen Med. 2010;3:1–17.
    1. Pisani P, Renna MD, Conversano F, Casciaro E, Di Paola M, Quarta E, et al. Major osteoporotic fragility fractures: risk factor updates and societal impact. World J Orthop. 2016;7:171–181. doi: 10.5312/wjo.v7.i3.171.
    1. Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012;60:1487–1492. doi: 10.1111/j.1532-5415.2012.04054.x.
    1. Theou O, Cann L, Blodgett J, Wallace LMK, Brothers TD, Rockwood K. Modification to the frailty phenotype criteria: systematic review of the current literature and investigation of 262 frailty phenotypes in the survey of health, ageing and retirement in Europe. Ageing Res Rev. 2015;21:78–94. doi: 10.1016/j.arr.2015.04.001.
    1. Cesari M, Prince M, Thiygarajan JA, Araujo De Carvalho I, Bernabei R, Chan P, et al. Frailty: An emerging public health priority. J Am Med Dir Assoc. 2016;17:188–192. doi: 10.1016/j.jamda.2015.12.016.
    1. Kojima G. Frailty as predictor of nursing home placement among community-dwelling older adults: a systematic review and meta-analysis. J Geriatr Phys Ther. 2016;00:1–7.
    1. Kanis JA, Odén A, McCloskey EV, Johansson H, Wahl DA, Cooper C. A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporosis Int. 2012;23:2239–2256. doi: 10.1007/s00198-012-1964-3.
    1. Dyer SM, Crotty M, Fairhall N, Magaziner J, Beaupre LA, Cameron ID, et al. A critical review of the long-term disability outcomes following hip fracture. BMC Geriatr. 2016;16:158. doi: 10.1186/s12877-016-0332-0.
    1. Hongisto MT, Nuotio M, Luukkaala T, Väistö O, Pihlajamäki HK. Does cognitive/physical screening in an outpatient setting predict institutionalization after hip fracture? BMC Musculoskelet Disord. 2016;17:444. doi: 10.1186/s12891-016-1272-8.
    1. Bertram M, Norman R, Kemp L, Vos T. Review of long-term disability associated with hip fractures. Injury Prevention. 2011;17:365–370. doi: 10.1136/ip.2010.029579.
    1. Abrahamsen B, van Staa T, Olson M, Cooper C. Excess mortality following hip fracture: a systematic epidemiological review. Osteoporosis Int. 2009;20:1633–1650. doi: 10.1007/s00198-009-0920-3.
    1. Kistler EA, Nicholas JA, Kates SL, Friedman SM. Frailty and short term outcomes in patients with hip fracture. Geriatr Orthoped Surg Rehabil. 2015;6:2019–2214.
    1. Beaupre LA, Binder EF, Cameron ID, Jones CA, Orwig D, Sherrington C, Magaziner J. Maximising functional recovery following hip fracture in frail seniors. Best Pract Res Clin Rheumatol. 2013;27:771–788. doi: 10.1016/j.berh.2014.01.001.
    1. Landi F, Marzetti E, Martone AM, Bernabei R, Onder G. Exercise as a remedy for sarcopenia. Curr Opin Clin Nutr Metab Care. 2014;17:25–31.
    1. Cadore EL, Rodríguez-Mañas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013;16:105–104. doi: 10.1089/rej.2012.1397.
    1. Cameron ID, Fairhall N, Langron C, Lockwood K, Monaghan N, Aggar C, et al. A multifactorial interdisciplinary intervention reduces frailty in older people: randomized trial. BMC Med. 2013. 10.1186/1741-7015-11-65.
    1. Cesari M, Vellas B, Hsu F-C, Newman AB, Doss H, King AC, et al. A physical activity intervention to treat the frailty syndrome in older persons – results from the LIFE-P study. J Gerontol A Biol Sci Med Sci. 2015;70:216–212. doi: 10.1093/gerona/glu099.
    1. Salpakoski A, Törmäkangas T, Edgren J, Kallinen M, Sihvonen SE, Arkela M, et al. Effects of multicomponent home-based physical rehabilitation program on mobility recovery after hip fracture: a randomized controlled trial. J Am Med Dir Assoc. 2014;15:361–368. doi: 10.1016/j.jamda.2013.12.083.
    1. Diong J, Allen N, Sherrington C. Structured exercise improves mobility after hip fracture: a meta-analysis with meta-regression. Br J Sports Med. 2016;50:346–355. doi: 10.1136/bjsports-2014-094465.
    1. Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012;16:601–608. doi: 10.1007/s12603-012-0084-2.
    1. Folstein MF, Folstein SE, McHug PR. “Mini mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189–198. doi: 10.1016/0022-3956(75)90026-6.
    1. Helldán A, Helakorpi S. Health Behaviour and Health among the Finnish elderly, Spring 2013, with trends 1993–2013. National Institute for Health and Welfare (THL), Report 15/2014. . Accessed 3 July 2017.
    1. Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, et al. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol Med Sci. 2000;55A:221–231. doi: 10.1093/gerona/55.4.M221.
    1. Kiresuk TJ, Sherman RE. Goal attainment scaling: a general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968;4:443–453. doi: 10.1007/BF01530764.
    1. Turner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin Rehabil. 2009;23:362–370. doi: 10.1177/0269215508101742.
    1. Thomas S, Mackintosh S, Halbert J. Does the ‘Otago exercise programme’ reduce mortality and falls in older adults? : A systematic review and meta-analysis. Age Ageing. 2010;39:681–687. doi: 10.1093/ageing/afq102.
    1. Avers D, Brown M. White paper: strength training for the older adult. J Geriatr Phys Ther. 2009;32:148–152. doi: 10.1519/00139143-200932040-00002.
    1. Chodzko-Zajko W, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Saslem GJ, et al. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009;7:1510–1530. doi: 10.1249/MSS.0b013e3181a0c95c.
    1. Cadore EL, Pinto RS, Bottaro M, Izquierdo M. Strength and endurance training prescription in healthy and frail elderly. Aging Dis. 2014;5:183–195. doi: 10.14336/AD.2014.0500183.
    1. Hazell T, Kenno K, Jakobi J. Functional benefit of power training for older adults. J Aging Phys Act. 2007;15:349–359. doi: 10.1123/japa.15.3.349.
    1. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14:377-1.
    1. de Vreede PL, Samson MM, van Meeteren NL, Duursma SA, Verhaar HJ. Functional-tasks exercise versus resistance strength exercise to improve daily function in older women: a randomized, controlled trial. J Am Geriatr Soc. 2005;53:2–10. doi: 10.1111/j.1532-5415.2005.53003.x.
    1. Vellas B, Villars H, Abellan G, Soto ME, Rolland Y, Guigoz Y, et al. Overview of the MNA® – its history and challenges. J Nutr Health Aging. 2006;10:456–465.
    1. Sund R, Juntunen M, Lüthje P, Huusko T, Häkkinen U. Monitoring the performance of hip fracture treatment in Finland. Ann Med. 2011;43(Suppl 1):39–46. doi: 10.3109/07853890.2011.586360.
    1. Giné-Garriga M, Roqué-Fíguls M, Coll-Plana L, Sitjà-Rabert M, Salvà A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arc Phys Med Rehab. 2014;95:753–769. doi: 10.1016/j.apmr.2013.11.007.
    1. de Vries NM, van Ravensberg CD, Hobbelen JSM, Olde Rikkert MGM, Staal JB. Nijhuis-van der Sanden MWG. Effects of physical exercise therapy on mobility, physical functioning, physical activity, physical disability and/or multi-morbidity: a meta-analysis. Ageing Res Rev. 2012;11:136–149. doi: 10.1016/j.arr.2011.11.002.
    1. Puts MTE, Toubasi S, Andrew MK, Ashe MC, Ploeg J, Atkinson E, et al. Interventions to prevent or reduce the level of frailty in community-dwelling older adults: a scoping review of the literature and international policies. Age Ageing. 2017;46:383–392.
    1. De Labra C, Guimares-Pinheiro C, Maseda A, Lorendo T, Millán-Calenti JC. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials. BMC Geriatr. 2015;15:154. doi: 10.1186/s12877-015-0155-4.
    1. Bauman A, Merom D, Bull FC, Buchner DM, Fiatarone Singh MA. Updating the evidence for physical activity: summative reviews of the epidemiological evidence, prevalence, and interventions to promote “active aging”. Gerontologist. 2016;56:268–280. doi: 10.1093/geront/gnw031.
    1. Theou Olga, Stathokostas Liza, Roland Kaitlyn P., Jakobi Jennifer M., Patterson Christopher, Vandervoort Anthony A., Jones Gareth R. The Effectiveness of Exercise Interventions for the Management of Frailty: A Systematic Review. Journal of Aging Research. 2011;2011:1–19. doi: 10.4061/2011/569194.
    1. Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, et al. Recovery from hip fracture. J Gerontol. 2000;55A:498–507. doi: 10.1093/gerona/55.9.M498.
    1. Auais MA, Eilayyan O, Mayo NE. Extended exercise rehabilitation after hip fracture improves patient’s physical function: a systematic review and meta-analysis. Phys Ther. 2012;92:1437–1451. doi: 10.2522/ptj.20110274.
    1. Orwig DL, Hochberg M, Yu-Yahiro J, Resnick B, Hawkes WG, Shardell M, et al. Delivery and outcomes of a yearlong home exercise program after hip fracture. A randomized controlled trial. Arch Intern Med. 2011;171:323–331. doi: 10.1001/archinternmed.2011.15.
    1. Yu-Yahiro J, Resnick B, Orwig D, Hicks G, Magaziner J. Design and implementation of a home-based exercise program post-hip fracture: the Baltimore hip studies experience. PM R. 2009;1:308–318. doi: 10.1016/j.pmrj.2009.02.008.
    1. Thiebault RS, Funk MD, Abe T. Home-based resistance training for older adults: a systematic review. Geriatr Gerontol Int. 2014;14:750–757. doi: 10.1111/ggi.12326.
    1. Hebert-Davies J, Laflamme G-Y, Rouleau D. HEALTH and FAITH investigators. Bias towards dementia: are hip fracture trials excluding too many patients? A systematic review. Injury. 2012;43:1978–1984. doi: 10.1016/j.injury.2012.08.061.
    1. Huusko TM, Karppi P, Avikainen V, Kautiainen H, Sulkava R. Randomised, clinically controlled trial of intensive geriatric rehabilitation in patients with hip fracture: subgroup analysis of patients with dementia. BMJ. 2000;321:1107–1111. doi: 10.1136/bmj.321.7269.1107.
    1. Pitkälä Kaisu H., Pöysti Minna M., Laakkonen Marja-Liisa, Tilvis Reijo S., Savikko Niina, Kautiainen Hannu, Strandberg Timo E. Effects of the Finnish Alzheimer Disease Exercise Trial (FINALEX) JAMA Internal Medicine. 2013;173(10):894. doi: 10.1001/jamainternmed.2013.359.
    1. Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9:179–186. doi: 10.1093/geront/9.3_Part_1.179.
    1. Granger CV, Hamilton BB, Zielezny M, Sherwin FS. Advances in functional assessment in medical rehabilitation. Top Geriatr Rehabil. 1986;1:59–74. doi: 10.1097/00013614-198604000-00007.
    1. Guralnik J, Simonsick E, Ferrucci L, Glynn R, Berkman L, Blazer D, et al. 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;49:85–94. doi: 10.1093/geronj/49.2.M85.
    1. Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, et al. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardized approach. Age Aging. 2011;40:423–429. doi: 10.1093/ageing/afr051.
    1. Sintonen H. The 15D instrument of health-related quality-of-life: properties and applications. Ann Med. 2001;33:328–336. doi: 10.3109/07853890109002086.
    1. Sintonen H. The 15D-measure of health-related quality of life. I. Reliability, validity and sensitivity of its health state descriptive system. Melbourne: National Centre for Health Program Evaluation, Working Paper 41; 1994.
    1. Sheikh JI, Yesavage JA. Geriatric depression scale (GDS): recent evidence and development of a shorter version. In: Brink TL, editor. Clinical gerontology: a guide to assessment and intervention. New York: The Haworth Press; 1986. pp. 165–163.
    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;34:614–619. doi: 10.1093/ageing/afi196.
    1. Kempen GI, Yardley L, van Haasregt JC, Zijlstra GA, Beyer N, Hauer K, et al. The short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008;37:45–50. doi: 10.1093/ageing/afm157.
    1. Cutrona CE, Russel DW. The provisions of social relationship and adaptation to stress. Adv Pers Relat. 1987;1:37–67.
    1. Scott J, Huskisson E. Graphic representation of pain. Pain. 1976;2:175–184. doi: 10.1016/0304-3959(76)90113-5.
    1. Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory care quality improvement project (ACQUIP) Arch Intern Med. 1998;158:1789–1795. doi: 10.1001/archinte.158.16.1789.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren