Effectiveness of a muticomponent workout program integrated in an evidence based multimodal program in hyperfrail elderly patients: POWERAGING randomized clinical trial protocol

Manuel González-Sánchez, Antonio Ignacio Cuesta-Vargas, María Del Mar Rodríguez González, Elvira Díaz Caro, Germán Ortega Núñez, Alejandro Galán-Mercant, Juan José Bedoya Belmonte, Manuel González-Sánchez, Antonio Ignacio Cuesta-Vargas, María Del Mar Rodríguez González, Elvira Díaz Caro, Germán Ortega Núñez, Alejandro Galán-Mercant, Juan José Bedoya Belmonte

Abstract

Background: Short-term and mid-term comparison of the efficacy of a multimodal program that incorporates a therapeutic workout program, medication review, diet adjustment and health education, in comparison to the standard medical practice in the improvement of the neuromuscular and physiological condition. Furthermore, it is intended to analyse the maintenance of these effects in a long-term follow-up (12 months) from the onset of the intervention.

Methods: A randomized clinical trial of elderly frail patients drawn from the Clinical Management Unit "Tiro de Pichón", Health District of Malaga, will be included in the study (after meeting the inclusion / exclusion criteria) will be randomized in two groups: a control group that will undergo an intervention consistent of medication review + diet adjustment + health education (regular workout recommendations within a complete advice on healthy lifestyles) and an experimental group whose intervention will consist of a multimodal treatment: therapeutic workout program+ medication review+ diet adjustment + health education. The sociodemographic, clinical and tracing variables will be reflected at the beginning of the study. In addition, the follow-up variables will be gathered at the second and sixth months after the beginning of the treatment and at the third and sixth months after the treatment (follow-up). The follow-up variables that will be measured are: body mass index, general health condition, fatigue, frailty, motor control, attention- concentration- memory, motor memory, spatial orientation, grip strength, balance (static, semi-dynamic), gait speed and metabolomics. A descriptive analysis of the sociodemographic variables of the participants will be conducted. One-Factor ANOVA will be used for the Within-Subject analysis and as for the Between-Subject analysis, the outcome variables between both the groups in each moment of the data collection will be compared.

Discussion: A multimodal program that incorporates a therapeutic workout program, medication review, diet adjustment and health education may be effective treatment to reduce the functional decline in elderly. The results of the study will provide information on the possible strengths and benefits in multimodal program in elderly.

Trial registration: ClinicalTrials.gov NCT02772952 registered May 2017.

Keywords: Diet; Elderly; Falls; Frailty; Physical activity; Physical fitness.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow Diagram is presented from the recruitment to the analysis after the follow-up (12 months)

References

    1. Wolrd Population Prospects. The 2010 Revision Population Database.
    1. Zamarrón Cassinello M, Activo E. Infocop. 2007;34:7–9.
    1. Organización Mundial de la Salud: Active Aging. Geneva; 2002.
    1. Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019. 10.1016/S0140-6736(19)31138-9. [Epub ahead of print] Review.
    1. World population prospects - population division - United Nations. .
    1. Instituto de Mayores y Servicios Sociales (IMSERSO): Informe 2006, Las Personas Mayores En España, Datos Estadísticos Estatales Y Por Comunidades Autónomas. 2006th edition.; 2006.
    1. Theou O, Cann L, Blodgett J, Wallace LMK, Brothers TD, Rockwood K. Modifications 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. Stenholm S, Shardell M, Bandinelli S, Guralnik JM, Ferrucci L. Physiological factors contributing to mobility loss over 9 years of follow-up—results from the InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2015;70:591–597. doi: 10.1093/gerona/glv004.
    1. Angevaren M, Aufdemkampe G, Verhaar H, Aleman A. Actividad física y mejoría del estado físico para favorecer la función cognitiva en personas mayores sin deterioro cognitivo comprobado. Oxford: la Biblioteca Cochrane Plus; 2008.
    1. Cho B, Scarpace D, Alexander NB. Tests of stepping as indicators of mobility, balance, and fall risk in balance-impaired older adults. J Am Geriatr Soc. 2004;52:1168–1173. doi: 10.1111/j.1532-5415.2004.52317.x.
    1. Bolandzadeh N, Kording K, Salowitz N, Davis JC, Hsu L, Chan A, Sharma D, Blohm G, Liu-Ambrose T. Predicting cognitive function from clinical measures of physical function and health status in older adults. PLoS One. 2015;10:e0119075. doi: 10.1371/journal.pone.0119075.
    1. Hildreth KL, Church S. Evaluation and management of the elderly patient presenting with cognitive complaints. Med Clin North Am. 2015;99:311–335. doi: 10.1016/j.mcna.2014.11.006.
    1. Cuesta-Vargas AI, Gabel PC. Cross-cultural adaptation, reliability and validity of the Spanish version of the upper limb functional index. Health Qual Life Outcomes. 2013;11:126. doi: 10.1186/1477-7525-11-126.
    1. Cohen AA, Milot E, Li Q, Bergeron P, Poirier R, Dusseault-Bélanger F, Fülöp T, Leroux M, Legault V, Metter EJ, Fried LP, Ferrucci L. Detection of a novel, integrative aging process suggests complex physiological integration. PLoS One. 2015;10:e0116489. doi: 10.1371/journal.pone.0116489.
    1. Nicholson JK, Lindon JC. Systems biology: Metabonomics. Nature. 2008;455:1054–1056. doi: 10.1038/4551054a.
    1. Tomlins AM, Foxall PJ, Lynch MJ, Parkinson J, Everett JR, Nicholson JK. High resolution 1H NMR spectroscopic studies on dynamic biochemical processes in incubated human seminal fluid samples. Biochim Biophys Acta. 1998;1379:367–380. doi: 10.1016/S0304-4165(97)00116-5.
    1. Decelle EA, Cheng LL. High-resolution magic angle spinning 1H MRS in prostate cancer. NMR Biomed. 2014;27:90–99. doi: 10.1002/nbm.2944.
    1. Giné-Garriga M, Roqué-Fíguls M, Coll-Planas 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. Arch Phys Med Rehabil. 2014;95:753–769.e3. doi: 10.1016/j.apmr.2013.11.007.
    1. VanSwearingen JM, Studenski SA. Aging, motor skill, and the energy cost of walking: implications for the prevention and treatment of mobility decline in older persons. J Gerontol A Biol Sci Med Sci. 2014;69:1429–1436. doi: 10.1093/gerona/glu153.
    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;73:1073–1080.
    1. Shumway-Cook A, Guralnik JM, Phillips CL, Coppin AK, Ciol MA, Bandinelli S, Ferrucci L. Age-associated declines in complex walking task performance: the walking InCHIANTI toolkit. J Am Geriatr Soc. 2007;55:58–65. doi: 10.1111/j.1532-5415.2006.00962.x.
    1. Bidargaddi N, Klingbeil L, Sarela A, Boyle J, Cheung V, Yelland C, Karunanithi M, Gray L. Wavelet based approach for posture transition estimation using a waist worn accelerometer. Conf Proc IEEE Eng Med Biol Soc. 2007;2007:1884–1887.
    1. Botolfsen P, Helbostad JL, Moe-Nilssen R, Wall JC. Reliability and concurrent validity of the expanded timed up-and-go test in older people with impaired mobility. Physiother Res Int. 2008;13:94–106. doi: 10.1002/pri.394.
    1. Galán-Mercant A, Cuesta-Vargas AI. Differences in trunk Accelerometry between frail and nonfrail elderly persons in sit-to-stand and stand-to-sit transitions based on a Mobile inertial sensor. JMIR mhealth and uhealth. 2013;1:e21. doi: 10.2196/mhealth.2710.
    1. Galán-Mercant A, Cuesta-Vargas AI. Differences in trunk kinematic between frail and nonfrail elderly persons during turn transition based on a smartphone inertial sensor. Biomed Res Int. 2013:279197.
    1. Galán-Mercant A, Cuesta-Vargas AI. Differences in trunk accelerometry between frail and non-frail elderly persons in functional tasks. BMC Res Notes. 2014;7:100. doi: 10.1186/1756-0500-7-100.
    1. Ganea R, Paraschiv-Ionescu A, Salarian A, Büla C, Martin E, Rochat S, Hoskovec C, Piot-Ziegler C, Aminian K. Kinematics and dynamic complexity of postural transitions in frail elderly subjects. Conf Proc IEEE Eng Med Biol Soc. 2007;2007:6118–6121.
    1. Ganea R, Paraschiv-Ionescu A, Büla C, Rochat S, Aminian K. Multi-parametric evaluation of sit-to-stand and stand-to-sit transitions in elderly people. Med Eng Phys. 2011;33:1086–1093. doi: 10.1016/j.medengphy.2011.04.015.
    1. Greene BR, Doheny EP, O’Halloran A, Anne Kenny R. Frailty status can be accurately assessed using inertial sensors and the TUG test. Age Ageing. 2014;43:406–411. doi: 10.1093/ageing/aft176.
    1. Higashi Y, Yamakoshi K, Fujimoto T, Sekine M, Tamura T. Quantitative evaluation of movement using the timed up-and-go test. IEEE Engineering in Medicine and Biology Magazine. 2008;27:38–46. doi: 10.1109/MEMB.2008.919494.
    1. Janssen WGM, Külcü DG, Horemans HLD, Stam HJ, Bussmann JBJ. Sensitivity of accelerometry to assess balance control during sit-to-stand movement. IEEE Trans Neural Syst Rehabil Eng. 2008;16:479–484. doi: 10.1109/TNSRE.2008.2003386.
    1. Marschollek M, Nemitz G, Gietzelt M, Wolf KH, Meyer Zu Schwabedissen H, Haux R. Predicting in-patient falls in a geriatric clinic: a clinical study combining assessment data and simple sensory gait measurements. Z Gerontol Geriatr. 2009;42:317–321. doi: 10.1007/s00391-009-0035-7.
    1. Martínez-Ramírez A, Lecumberri P, Gómez M, Rodriguez-Mañas L, García FJ, Izquierdo M. Frailty assessment based on wavelet analysis during quiet standing balance test. J Biomech. 2011;44:2213–2220. doi: 10.1016/j.jbiomech.2011.06.007.
    1. Moe-Nilssen R, Helbostad JL. Estimation of gait cycle characteristics by trunk accelerometry. J Biomech. 2004;37:121–126. doi: 10.1016/S0021-9290(03)00233-1.
    1. Moe-Nilssen R, Helbostad JL. Interstride trunk acceleration variability but not step width variability can differentiate between fit and frail older adults. Gait Posture. 2005;21:164–170. doi: 10.1016/j.gaitpost.2004.01.013.
    1. Najafi B, Aminian K, Loew F, Blanc Y, Robert PA. Measurement of stand-sit and sit-stand transitions using a miniature gyroscope and its application in fall risk evaluation in the elderly. IEEE Trans Biomed Eng. 2002;49:843–851. doi: 10.1109/TBME.2002.800763.
    1. Salarian A, Zampieri C, Horak FB, Carlson-Kuhta P, Nutt JG, Aminian K. Analyzing 180° turns using an inertial system reveals early signs of progress in Parkinson’s disease. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:224–227.
    1. Salarian A, Horak FB, Zampieri C, Carlson-Kuhta P, Nutt JG, Aminian K. iTUG, a sensitive and reliable measure of mobility. IEEE Trans Neural Syst Rehabil Eng. 2010;18:303–310. doi: 10.1109/TNSRE.2010.2047606.
    1. Weiss A, Herman T, Plotnik M, Brozgol M, Maidan I, Giladi N, Gurevich T, Hausdorff JM. Can an accelerometer enhance the utility of the timed up & go test when evaluating patients with Parkinson’s disease? Med Eng Phys. 2010;32:119–125. doi: 10.1016/j.medengphy.2009.10.015.
    1. Weiss A, Herman T, Plotnik M, Brozgol M, Giladi N, Hausdorff JM. An instrumented timed up and go: the added value of an accelerometer for identifying fall risk in idiopathic fallers. Physiol Meas. 2011;32:2003–2018. doi: 10.1088/0967-3334/32/12/009.
    1. Zampieri C, Salarian A, Carlson-Kuhta P, Aminian K, Nutt JG, Horak FB. The instrumented timed up and go test: potential outcome measure for disease modifying therapies in Parkinson’s disease. J Neurol Neurosurg Psychiatry. 2010;81:171–176. doi: 10.1136/jnnp.2009.173740.
    1. Zampieri C, Salarian A, Carlson-Kuhta P, Nutt JG, Horak FB. Assessing mobility at home in people with early Parkinson’s disease using an instrumented timed up and go test. Parkinsonism Relat Disord. 2011;17:277–280. doi: 10.1016/j.parkreldis.2010.08.001.
    1. Galán-Mercant A, Barón-López FJ, Labajos-Manzanares MT, Cuesta-Vargas AI. Reliability and criterion-related validity with a smartphone used in timed-up-and-go test. Biomed Eng Online. 2014;13:156. doi: 10.1186/1475-925X-13-156.
    1. Cuesta-Vargas AI, Galán-Mercant A, Williams JM. The use of inertial sensors system for human motion analysis. Phys Ther Rev. 2010;15:462–473. doi: 10.1179/1743288X11Y.0000000006.
    1. Shaw M, Adam CJ, Izatt MT, Licina P, Askin GN. Use of the iPhone for cobb angle measurement in scoliosis. Eur Spine J. 2011.
    1. Xia Y, Cheung V, Garcia E, Ding H, Karunaithi M. Development of an automated physical activity classification application for mobile phones. Stud Health Technol Inform. 2011;168:188–194.
    1. Sun B, Wang Y, Banda J. Gait characteristic analysis and identification based on the iPhone’s accelerometer and gyrometer. Sensors (Basel) 2014;14:17037–17054. doi: 10.3390/s140917037.
    1. Misic MM, Rosengren KS, Woods JA, Evans EM. Muscle quality, aerobic fitness and fat mass predict lower-extremity physical function in community-dwelling older adults. Gerontology. 2007;53:260–266. doi: 10.1159/000101826.
    1. Reeves ND, Narici MV, Maganaris CN. Effect of resistance training on skeletal muscle-specific force in elderly humans. J Appl Physiol. 2004;96:885–892. doi: 10.1152/japplphysiol.00688.2003.
    1. Cadore EL, Pinto RS, Pinto SS, Alberton CL, Correa CS, Tartaruga MP, Silva EM, Almeida APV, Trindade GT, Kruel LFM. Effects of strength, endurance, and concurrent training on aerobic power and dynamic neuromuscular economy in elderly men. J Strength Cond Res. 2011;25:758–766. doi: 10.1519/JSC.0b013e318207ed66.
    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. Bell GJ, Syrotuik D, Martin TP, Burnham R, Quinney HA. Effect of concurrent strength and endurance training on skeletal muscle properties and hormone concentrations in humans. Eur J Appl Physiol. 2000;81:418–427. doi: 10.1007/s004210050063.
    1. Cabrero-García J, Muñoz-Mendoza CL, Cabañero-Martínez MJ, González-Llopís L, Ramos-Pichardo JD, Reig-Ferrer A. Valores de referencia de la Short Physical Performance Battery para pacientes de 70 y más años en atención primaria de salud. Atención Primaria. 2012;44:540–548. doi: 10.1016/j.aprim.2012.02.007.
    1. Ross W, Hebbelinck M, Faulkner R. Kinantropometry terminology and landmarks. in Shepard R, and Lavalle H. physical fitness Asessment. Charles tomas. Sprinfield: 1978.
    1. Vigalut G, Valderas JM, Ferrer M, Lopez-Garcia E, Garin O, Alonso J. Interpretation of sf36 and sf12 questionnaires in Spain: physical and mental components. Med Clin. 2008;130(19):726–735. doi: 10.1157/13121076.
    1. Andrade Elena, Arce Constantino, Torrado Julio, Garrido Javier, De Francisco Cristina, Arce Iria. Factor Structure and Invariance of the POMS Mood State Questionnaire in Spanish. The Spanish journal of psychology. 2010;13(1):444–452. doi: 10.1017/S1138741600003991.
    1. Di Bari M, Profili F, Bandinelli S, Salvioni A, Mossello E, Corridori C, Francesconi P. Screening for frailty in older adults using a postal questionnaire: rationale, methods, and instruments validation of the INTER- FRAIL study. J Am Geriatr Soc. 2014;62(10):1933–1937. doi: 10.1111/jgs.13029.
    1. Lobo A, Saz P, Marcos G, Grupo de Trabajo ZARADEMP. MMSE: Examen Cognoscitivo Mini-Mental Madrid: TEA Ediciones;2002.
    1. Wechsler, D. Escala de inteligencia de Wechsler para adultos-IV. Manual de aplicación y corrección. Madrid: NCS Pearson, Inc. Edición original, 2008.
    1. Rey Cao A, Canales Lacruz I, Táboas País I, Cancela Carra JM «Memoria en movimiento» programa de estimulación cognitiva a través de la motricidad para personas mayores de la obra social Caixa Galicia. retrieved May 30, 2019 from .
    1. Colom R, Contreras MJ, Shih PC Santacreu J. The assessment of spatial ability through a single computerized test. Eur J Psychol Assess. 2003;19(2):92–100. doi: 10.1027//1015-5759.19.2.92.
    1. Bellace JV, Healy D, Besser MP, Byron T, Hohman L. Validity of the Dexter evaluation System’s Jamar dynamometer attachment for assessment of hand grip strength in a normal population. J Hand Ther: Official J Am Soc Hand Ther. 2000;13(1):46–51. doi: 10.1016/S0894-1130(00)80052-6.
    1. Podsiadlo D, Richardson S. The timed “up & go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–148. doi: 10.1111/j.1532-5415.1991.tb01616.x.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera