Clinical trial NCT03390478: Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products
Official title: MIND&GAIT - Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Cognition
Mild Cognitive Impairment
Keywords: Frailty
Aged
Cognitive Stimulation
Technology
Lead sponsor: Escola Superior de Enfermagem de Coimbra
Sponsor class: OTHER
Collaborators: name: Instituto Politécnico de Coimbra
name: Instituto Politécnico de Leiria
name: Polytechnic University of Santarém
First posted: 2018-01-04
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned in two groups, a control group who will receive institutional usual care and an experimental group who will receive the combined intervention.
Primary purpose: PREVENTION

Brief summary: A strategy involving 6 partners was planned, targeting the components of education, innovation, and practice-based research with knowledge transfer into clinical practice.The project MIND\&GAIT aims to promote independent living in frail older people through the development of innovative initiatives and systems to improve cognition and gait ability. A structured and integrated Combined Intervention (CI) will be developed, composed by: cognitive stimulation program, an animal-assisted therapy program, a physical activity program. Moreover, an auto-blocking mechanism for rolling walkers will be developed and implemented in this study. The results of the study and all the material that was used, will be disseminated in a web platform.

Detailed description: In this growing context of aging societies, the number of institutionalized older adults tends to increase. Several reasons lead to the institutionalization of older people, including physical and cognitive decline. In Portugal,in the population aged over 60 years, there was approximately 160,287 people with dementia, which corresponds to 5.91% of the people covered by these age groups. Mild cognitive impairment (MCI) is considered as an intermediate state between normal cognitive ageing and mild dementia, particularly in older people. It is increasingly recognized as a major health problem associated with an increased risk for dementia. Cognitive health maintenance is essential for preventing cognitive impairment and delaying the onset of dementia, dependency, and (in)ability to self-care. In older people with cognitive decline, cognitive stimulation can be a promising intervention for reducing depressive symptoms and depressive vulnerability, improving their quality of life. On the other hand, healthy ageing has traditionally focused on disease prevention, but greater efforts are needed to reduce frailty and dependency, and maintain independent physical and cognitive function among older adults. The aging process associated with a sedentary lifestyle can lead to the decline of some physical capacities. Maintaining functional status and reducing age-related morbidity is an important part of active ageing policies; it promotes independent living, improves the quality of life, and reduces health care costs. In this way exercise programs reduce age-related decline in functional capacity and maintain muscle strength and mass among adults aged 65-85 years.

The research team intend to intervene in the promotion of active ageing, including physical exercise and activities that promote the delay and/or maintenance of the cognitive and physical health of frail older people.

In this way, a randomized controlled trial will be conducted by the research team, composed by two arms: experimental group (CI group) and control group. The aim of this study is to assess the impact of the CI program on frail older people. The evaluation of the effectiveness of the Combined Intervention will have the following methodology:

- Sample Test: For sample size calculation it was used the software G\*Power 3.1.9.2. Power analysis was based on a type I error of 0.05; power of 0.80; effect size f=0.30; and ANOVA: repeated measures between factors determined a total sample size of 62.Participants with more than 65 or more years will be recruited from two homes for the aged. Participants will be randomly distributed in groups of 8, in the control group and in the experimental group. Participants will be classified as having mild to moderate cognitive decline and risk of fall from mild to moderate. The control group will receive usual care.

-Intervention: The combined intervention will be implemented over 21 weeks, 4 times a week. Cognitive Stimulation Program (CSP) will be applied once a week and Physical Activity Program (PAP) 3 times a week for 30-60 min. Participants using rolling walkers will benefit from the autoblocking kit mechanism for rolling walkers mechanism (ABMRW) during the execution of the PAP.

-Data analysis: Statistical analysis will be performed through repeated meaures and ANOVA. Age, gender, and initial scores of depression and Activities of Daily Living (ADLs) will be introduced as covariates. Intention-to-treat analysis will be done to analyze the data of the people who left the study.

Eligibility criteria: Inclusion Criteria:

* Older adults, age 65 or above;
* Older adults with the ability to consent in an informed manner their participation in the study;
* Older adults with clinical conditions that allow them to participate in the combined intervention;
* Older adults with mild to moderate cognitive frailty criteria as per the 6-CIT scale;
* Older adults with mild to moderate depressive status as per the Geriatric Depression Scale (15 items version).
* Older adults that present mild to moderate risk of fall tracked by Tinetti Index;
* Older adults with physical frailty tracked by the biomechanical gait parameters.

Exclusion Criteria:

* Older adults without a stable clinical condition;
* Older adults with a cardiac condition that enables them practice of physical activity;
* Older adults that do not have the desire of participate in the study.

Primary outcomes:
measure: Change from Baseline in the participant's Cognition
timeFrame: Intermediate assessment (week 12)
measure: Change from Baseline in the participant's Cognition
timeFrame: Post-intervention assessment (week 21)
measure: Change from Baseline in the participant's Physical Frailty
timeFrame: Intermediate assessment (week 12)
measure: Change from Baseline in the participant's Physical Frailty
timeFrame: Post-intervention assessment (week 21)
Secondary outcomes:
measure: Change from Baseline in the participant's Activities of Daily Living
timeFrame: Intermediate assessment (week 12)
measure: Change from Baseline in the participant's Activities of Daily Living
timeFrame: Post-intervention assessment (week 21)
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Health Sciences Research Unit: Nursing
Study officials:
affiliation: Nursing School of Coimbra (ESEnfC)
name: João Apóstolo, Aggregation
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradley SM, Hernandez CR. Geriatric assistive devices. Am Fam Physician. 2011 Aug 15;84(4):405-11.
citation: Peretz C, Korczyn AD, Shatil E, Aharonson V, Birnboim S, Giladi N. Computer-based, personalized cognitive training versus classical computer games: a randomized double-blind prospective trial of cognitive stimulation. Neuroepidemiology. 2011;36(2):91-9. doi: 10.1159/000323950. Epub 2011 Feb 10.
citation: Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. doi: 10.1016/0002-9343(86)90717-5.
citation: Reeves ND, Narici MV, Maganaris CN. Musculoskeletal adaptations to resistance training in old age. Man Ther. 2006 Aug;11(3):192-6. doi: 10.1016/j.math.2006.04.004. Epub 2006 Jun 19.
citation: Skelton DA, Beyer N. Exercise and injury prevention in older people. Scand J Med Sci Sports. 2003 Feb;13(1):77-85. doi: 10.1034/j.1600-0838.2003.00300.x.
citation: Narici MV, Maganaris CN, Reeves ND, Capodaglio P. Effect of aging on human muscle architecture. J Appl Physiol (1985). 2003 Dec;95(6):2229-34. doi: 10.1152/japplphysiol.00433.2003. Epub 2003 Jul 3.
citation: Narici MV, Maffulli N. Sarcopenia: characteristics, mechanisms and functional significance. Br Med Bull. 2010;95:139-59. doi: 10.1093/bmb/ldq008. Epub 2010 Mar 2.
citation: Macaluso A, De Vito G. Muscle strength, power and adaptations to resistance training in older people. Eur J Appl Physiol. 2004 Apr;91(4):450-72. doi: 10.1007/s00421-003-0991-3. Epub 2003 Nov 25.
citation: Puthoff ML, Nielsen DH. Relationships among impairments in lower-extremity strength and power, functional limitations, and disability in older adults. Phys Ther. 2007 Oct;87(10):1334-47. doi: 10.2522/ptj.20060176. Epub 2007 Aug 7.
citation: Skelton DA. Effects of physical activity on postural stability. Age Ageing. 2001 Nov;30 Suppl 4:33-9. doi: 10.1093/ageing/30.suppl_4.33. No abstract available.
citation: Paiva, Diana S; Apóstolo, João L. A. 2015. Estudo de adaptação transcultural e validação do Six Item Cognitive Impairment Test . In J. Apóstolo & M. Almeida (Eds). Elderly Health Care Nursing. Monographic Series - Health Sciences Education and Research, 3 - 18. ISBN: 978-989-99426-1-5. Coimbra: Unidade de Investigação em Ciências da Saúde: Enfermagem (UICISA: E) ESEnfC.
citation: Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.
citation: Carter ND, Kannus P, Khan KM. Exercise in the prevention of falls in older people: a systematic literature review examining the rationale and the evidence. Sports Med. 2001;31(6):427-38. doi: 10.2165/00007256-200131060-00003.
citation: Bandeira, M. L., Azevedo, A. B., Gomes, C. S., Tomé, L. P., Mendes, M. F., Baptista, M. I., & Moreira, M. J. (2014). Dinâmicas demográficas e envelhecimento da população portuguesa( 1950-2011): evolução e perspetivas. Lisboa: Francisco Manuel dos Santos.
citation: Santana I, Farinha F, Freitas S, Rodrigues V, Carvalho A. [The Epidemiology of Dementia and Alzheimer Disease in Portugal: Estimations of Prevalence and Treatment-Costs]. Acta Med Port. 2015 Mar-Apr;28(2):182-8. Epub 2015 May 29. Portuguese.
citation: Sousa, R. (2015). Prevenção de quedas na população geriátrica artigo de revisão. Coimbra, Portugal: Faculdade de Medicina da Universidade de Coimbra.
citation: 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 Apr;56 Suppl 2:S268-80. doi: 10.1093/geront/gnw031.
citation: American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
citation: Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C; American College of Sports Medicine; American Heart Association. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1094-105. doi: 10.1161/CIRCULATIONAHA.107.185650. Epub 2007 Aug 1.
citation: Paterson DH, Warburton DE. Physical activity and functional limitations in older adults: a systematic review related to Canada's Physical Activity Guidelines. Int J Behav Nutr Phys Act. 2010 May 11;7:38. doi: 10.1186/1479-5868-7-38.
citation: Tak E, Kuiper R, Chorus A, Hopman-Rock M. Prevention of onset and progression of basic ADL disability by physical activity in community dwelling older adults: a meta-analysis. Ageing Res Rev. 2013 Jan;12(1):329-38. doi: 10.1016/j.arr.2012.10.001. Epub 2012 Oct 10.
citation: European Union. (2013). Action Group A3 on Prevention and early diagnosis of frailty and functional decline, both physically and cognitive, in older people: A compilation of good practices. The European Innovation Partnership on Active and Healthy Ageing.
citation: Apostolo J, Cooke R, Bobrowicz-Campos E, Santana S, Marcucci M, Cano A, Vollenbroek M, Holland C. Effectiveness of the interventions in preventing the progression of pre-frailty and frailty in older adults: a systematic review protocol. JBI Database System Rev Implement Rep. 2016 Jan;14(1):4-19. doi: 10.11124/jbisrir-2016-2467. No abstract available.
citation: Apostolo J, Cooke R, Bobrowicz-Campos E, Santana S, Marcucci M, Cano A, Vollenbroek-Hutten M, Germini F, Holland C. Predicting risk and outcomes for frail older adults: an umbrella review of frailty screening tools. JBI Database System Rev Implement Rep. 2017 Apr;15(4):1154-1208. doi: 10.11124/JBISRIR-2016-003018.
citation: Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
citation: Kojima G. Prevalence of Frailty in Nursing Homes: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2015 Nov 1;16(11):940-5. doi: 10.1016/j.jamda.2015.06.025. Epub 2015 Aug 6.
citation: Sternberg SA, Wershof Schwartz A, Karunananthan S, Bergman H, Mark Clarfield A. The identification of frailty: a systematic literature review. J Am Geriatr Soc. 2011 Nov;59(11):2129-38. doi: 10.1111/j.1532-5415.2011.03597.x. Epub 2011 Sep 21.
citation: Langlois F, Vu TT, Kergoat MJ, Chasse K, Dupuis G, Bherer L. The multiple dimensions of frailty: physical capacity, cognition, and quality of life. Int Psychogeriatr. 2012 Sep;24(9):1429-36. doi: 10.1017/S1041610212000634. Epub 2012 Apr 25.
citation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
citation: Varadhan R, Seplaki CL, Xue QL, Bandeen-Roche K, Fried LP. Stimulus-response paradigm for characterizing the loss of resilience in homeostatic regulation associated with frailty. Mech Ageing Dev. 2008 Nov;129(11):666-70. doi: 10.1016/j.mad.2008.09.013. Epub 2008 Sep 30.
citation: Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
citation: Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.
citation: Elliott, S. M. (2015). The Psychological Benefits of Animal Assisted Therapy on Elderly Nursing Home Patients. University of Akron: Ohio?s Polytechnic University.
citation: Bono, A. V., BenVenuti, C., Buzzi, M., CiAtti, R., ChiARelli, V., ChiAMBRetto, P., ... & PinCiRoli, M. (2015). Effects of animal assisted therapy (AAT) carried out with dogs on the evolution of mild cognitive impairment. G Gerontol, 63, 32-36.
citation: Aguirre E, Hoare Z, Spector A, Woods RT, Orrell M. The effects of a Cognitive Stimulation Therapy [CST] programme for people with dementia on family caregivers' health. BMC Geriatr. 2014 Mar 14;14:31. doi: 10.1186/1471-2318-14-31.
citation: Yuill N, Hollis V. A systematic review of cognitive stimulation therapy for older adults with mild to moderate dementia: an occupational therapy perspective. Occup Ther Int. 2011 Dec;18(4):163-86. doi: 10.1002/oti.315. Epub 2011 Mar 21.
citation: Apóstolo, J., & Cardoso, D. (2014a). Estimulação Cognitiva em Idosos - Síntese da Evidência e Intervenção. In L. coord. Loureiro (Ed.), Literacia em Saúde Mental - Capacitar as pessoas e as Comunidades para Agir (pp. 157?183). Coimbra: Unidade de Investigação em Ciências da Saúde: Enfermagem e Escola Superior de Enfermagem de Coimbra.
citation: Apóstolo, J., & Cardoso, D. (2014b). Estimulação Cognitiva em Idosos - Síntese da Evidência e Intervenção: Programa de Manutenção. In M. Apóstolo, J.; Almeida (Ed.), Envelhecimento, Saúde e Cidadania 2: Monographic Series Health Sciences Education and Research (pp. 37?66). Coimbra.
citation: Cognitive stimulation and brain fitness. In Action Group A3 on Prevention and early diagnosis of frailty and functional decline, both physically and cognitive, in older people: A compilation of good practices. The European Innovation Partnership on Active and Healthy Ageing.
citation: Apostolo JL, Cardoso DF, Rosa AI, Paul C. The effect of cognitive stimulation on nursing home elders: a randomized controlled trial. J Nurs Scholarsh. 2014 May;46(3):157-66. doi: 10.1111/jnu.12072. Epub 2014 Mar 5.
citation: Apostolo J, Holland C, O'Connell MD, Feeney J, Tabares-Seisdedos R, Tadros G, Campos E, Santos N, Robertson DA, Marcucci M, Varela-Nieto I, Crespo-Facorro B, Vieta E, Navarro-Pardo E, Selva-Vera G, Balanza-Martinez V, Cano A. Mild cognitive decline. A position statement of the Cognitive Decline Group of the European Innovation Partnership for Active and Healthy Ageing (EIPAHA). Maturitas. 2016 Jan;83:83-93. doi: 10.1016/j.maturitas.2015.10.008. Epub 2015 Oct 22.
citation: Apóstolo, J., Loureiro, L., Reis, I., Silva, I., Cardoso, D., & Sfectcu, R. (2014). Contribuição para a adaptação da Geriatric Depression Scale -15 para a língua portuguesa. Revista de Enfermagem Referência, Série 3 (3), 65?73.
citation: American College of Sports Medicine. (2013). ACSM's guidelines for exercise testing and prescription. Lippincott Williams & Wilkins. ISBN-13: 978-1609136055.
citation: Ramalho F, Carnide F, Santos-Rocha R, Andre HI, Moniz-Pereira V, Machado ML, Veloso AP. Community-Based Exercise Intervention for Gait and Functional Fitness Improvement in an Older Population: Study Protocol. J Aging Phys Act. 2017 Jan;25(1):84-93. doi: 10.1123/japa.2015-0290. Epub 2016 Sep 6.
citation: Schwenk M, Howe C, Saleh A, Mohler J, Grewal G, Armstrong D, Najafi B. Frailty and technology: a systematic review of gait analysis in those with frailty. Gerontology. 2014;60(1):79-89. doi: 10.1159/000354211. Epub 2013 Aug 15.
citation: Van Abbema R, De Greef M, Craje C, Krijnen W, Hobbelen H, Van Der Schans C. What type, or combination of exercise can improve preferred gait speed in older adults? A meta-analysis. BMC Geriatr. 2015 Jul 1;15:72. doi: 10.1186/s12877-015-0061-9.
citation: Madeira, J., Silva, C., Marcelino, L., & Ferreira, P. (2015). Assistive Mobile Applications for Dyslexia. Procedia Computer Science, 64, 417-424.
citation: Ribeiro J, Souza DN, Costa AP. Qualitative research in the area of health: the whys and wherefores. Cien Saude Colet. 2016 Aug;21(8):2324. doi: 10.1590/1413-81232015218.15612016. No abstract available. English, Portuguese.