Skip to main content

Effectiveness of a multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: study protocol for a randomized clinical controlled trial

Abstract

Background

There is increasing evidence suggesting that cognition and physical frailty interact within a cycle of decline associated with aging which has been called cognitive frailty. Exercise programs have demonstrated to be an effective tool to prevent functional and cognitive decline during aging, but little is known about their potential to restore or maintain functionality in individuals that require long-term nursing care. Besides, WHO has recently highlighted the importance of introducing systematic musculoskeletal health programs for older people living in residential care, as they represent a particularly vulnerable group for the development of noncommunicable diseases.

Methods

This is a multicentre randomized controlled trial. 114 participants will be randomly allocated to a usual care group or to an intervention group. Inclusion criteria are as follows: ≥ 70 years, ≥ 50 on the Barthel Index, ≥ 20 on MEC-35 who are capable to stand up and walk independently for 10 m. Subjects in the intervention group will add to the activities scheduled for the control group the participation in a 6 months long multicomponent exercise program designed to improve strength, balance and walking retraining. Study assessments will be conducted at baseline and at 3 and 6 months. The primary outcome is change in function assessed by Short Physical Performance Battery and secondary outcomes include other measurements to assess all together the condition of frailty, which includes functionality, sedentary behaviors, cognitive and emotional status and biological markers. The present study has been approved by the Committee on Ethics in Research of the University of the Basque Country (Humans Committee Code M10/2016/105; Biological Samples Committee Code M30/2016/106).

Discussion

Results from this research will show if ageing related functional and cognitive deterioration can be effectively prevented by physical exercise in institutionalized elders. It is expected that the results of this research will guide clinical practice in nursing home settings, so that clinicians and policymakers can provide more evidence-based practice for the management of institutionalized elder people.

Trial registration

The protocol has been registered under the Australian and New Zealand Clinical Trials Registry (ANZCTR) with the identifier: ACTRN12616001044415.

Peer Review reports

Background

Globally, older adult population is estimated to reach approximately 22% of the world’s population by 2050 [1, 2] due to the increase in life expectancy. Those older people are characterized by a particularly higher risk of developing negative health-related events because of an age-associated decline in physical and cognitive functions, leading to a progressive disability status. This condition of risk (generally indicated as “frailty”) may support the differentiation of “chronologically” from “biologically” aged individuals in the heterogeneous group of elders [3], and consequently, has emerged as a major clinical and public health priority providing a challenge for health and social care resources development [4].

Otherwise, age-associated frailty is a major concern in geriatrics because of its high prevalence in older persons [57] and because it is associated with a greater incidence of disability, hospitalization and death [8]. Although frailty references focus usually on its physical side, there is increasing evidence suggesting that cognition and physical frailty interact within a cycle of decline associated with aging [9]. Actually, affective psychological aspects such as anxiety [10] and depression [11], subjective well-being [12] and quality of life [13, 14] of people are also closely related to frailty.

In this regard, researchers from the International Academy of Nutrition and Aging (IANA) and the International Association of Gerontology and Geriatrics (IAGG) have recently established a definition for “cognitive frailty” in older adults [15]: “an heterogeneous clinical manifestation characterized by the simultaneous presence of physical frailty and cognitive impairment. In particular, the key factors that define such conditions include: 1) the presence of physical frailty and cognitive impairment; and 2) the exclusion of a concurrent clinical diagnosis of Alzheimer disease or other dementias”.

Exercise programs have demonstrated to prevent functional and cognitive decline during aging [1618]. In the last decade, the study of exercise programs exploring its benefits has been mainly focused on community-dwelling older adults [19], when frailty is identified at an early stage. When compared with control interventions, physical exercise programs have shown to reverse frailty and improve cognition, emotional, and social networking in controlled populations of community-dwelling frail older adults [20, 21]. Otherwise, while it is widely accepted that frailty can be considered reversible at early stages, mild to moderate disability has proven to be hardly reversible by interventions at old age [22], when individuals require long-term nursing care.

In spite of the widely known health benefits associated with physical activity, older adults represent a very sedentary behavior cohort [23, 24]. Sedentary behavior refers to any waking activity characterized by low energy expenditure (1.0 to 1.5 basal metabolic rate) and a sitting or reclining posture [25]. There is a new body of evidence centered on the negative impact of sedentary behaviors for health, which links it with a higher risk of cardiovascular disease, metabolic syndrome, obesity, and other negative health outcomes, independent of physical activity levels, among older adults [26, 27]. Furthermore, several studies have demonstrated the association between the sedentary behaviors and the development of functional limitations in older adults [2835]. Nevertheless, little is known about the associations of sedentary behavior with variables that are important for successful aging including mental [36, 37], cognitive [38], biological markers [39] and quality of life indicators [4042].

Finally, about 60 different potential biomarkers of frailty have been postulated, most of them involved in inflammation, oxidative stress and metabolism which affect different organ systems [43, 44]. Inflammation appears to play a major role in the pathophysiology of frailty; in fact, a positive relationship between frailty-related indexes and markers of inflammation has been observed [45]. Several studies have also detected higher serum levels of interleukin 6 (IL-6), CRP and IL-1Ra in fragile patients, which have been associated with lower muscle strength and a slower gait [4648]. On the other hand, brain-derived neural factor (BDNF) which is related to brain plasticity and function, has demonstrated to be influenced by physical exercise [49]. Despite this evidence, nowadays there is no clear consensus about the validity of such biomarkers in primary and hospital care and they are not commonly used for identifying frailty in clinical settings.

Objective

To the knowledge of the authors, no studies have explored the effects of a supervised multicomponent exercise program carried out in long-term nursing care centers from a broad perspective of the condition of frailty, assessing all together functionality, sedentary behaviors, cognitive and emotional status and biological markers. Thus, it has been designed a randomized multicenter study to test the hypothesis that the addition of a multicomponent exercise program to the usual care in institutionalized elders can improve their functionality in 1 point in the Short Physical Performance Battery (SPPB).

The major aim of this study is to ascertain if a supervised multicomponent exercise program carried out in long-term nursing care centers improves or maintains functionality, sedentary behaviors, cognitive and emotional status, health related quality of life and modifies biological markers related to frailty when compared with a control population that received usual care.

The present study is based on a previous pilot study [50] in which we successfully collected preliminary data to accurately demonstrate the feasibility of recruitment, estimate the required sample size for the current trial, confirm the adherence and safety of the intervention, refine the outcome assessments, and optimize the organizational infrastructure.

Methods

Study design and participants

With the above mentioned objective in mind, it has been designed an experimental multicentre simple randomized study, with random allocation to a usual care group or to an intervention group. Each site will enroll on average 15 subjects. Researchers responsible for data gathering will be blinded for this study. Participants will be recruited from Matia and Caser Residential Care Facilities in 7 long-term nursing homes (San Sebastian, Basque Country, Spain). It is expected that the intervention will take place between October 2016 and June 2017. Study assessments will be conducted by blinded research staff during clinic visits at baseline, as well as at 3 and 6 months from the beginning of the intervention. The CONSORT Statement extension for trials of non-pharmacological interventions and pragmatic intervention trials has been used to design the study and will be used to report it (Fig. 1).

Fig. 1
figure 1

Study protocol description

Inclusion and exclusion criteria

Subjects will be considered eligible for the study if they fulfill all of the following criteria: aged ≥ 70 years, scored ≥ 50 on the Barthel Index [51], scored ≥ 20 on MEC-35 [52] Test (an adapted and validated version of Mini Mental State Examination (MMSE) in Spanish) who are all capable to stand up and walk independently for at least 10 m.

Participants will not be eligible for the study if they are clinically unstable under the clinical judgment of the medical professionals of the reference center, or in any other condition that means that entering the study would not be in the subject’s best interests.

Recruitment and randomization

The listing of individuals that meet inclusion criteria will be obtained from the database of Matia and Caser Residential Care Facilities. The primary recruitment strategy will be information provided to the potential participants by the medical and nursing professionals from each nursing home. All the volunteers will receive detailed study information in their reference sites through the research team: objectives, measurement variables and other details about the interventions will be explained orally and in writing, to both potential participants and their families. Informed consent will be obtained from each participant who will sign it after fully understanding the procedures. Afterwards they will be randomly assigned (1:1 ratio) by center through sealed opaque envelopes to either the control or the intervention group by coin-tossing sequence generation.

Control group

Subjects in the control group will participate in the routine activities that all nursing homes usually offer to the attendees: memory workshops, reading, singing, etc. Activities will be low intensity in any case.

Multicomponent exercise program

Subjects in the intervention group will add to the activities scheduled for the control group, the participation in a multicomponent exercise program designed to improve strength, balance and walking retraining conducted by an experienced physical trainer. Strength and balance training will be performed through supervised sessions, while walking retraining will be carried out through individualized recommendations that participants will fulfill on their own. The technical content of the program is based on a specific literature review [17, 53, 54] including authors’ expertise and field experience, and it is divided into two sections of 3 months long (Table 1). Each section has specific objectives and a standardized framework (combination and sequence of exercises), but the goals are individualized based on each participants’ level of physical fitness. Goals will be adapted in response to illness, injury or physical symptoms. The intervention has been designed to meet the exercise and physical activity guidelines for older adults established by the American College of Sport Medicine (ACSM) and American Heart Association (AHA) [55, 56]. Training attendance will be recorded every session.

Table 1 Multicomponent exercise program’s technical content

Forty-five min supervised sessions directed to improve strength and balance will be conducted twice a week. An interval of at least 48 h between training sessions will be respected (Table 2). All sessions will begin with a brief warm-up of 5 min (range-of-motion exercises for the neck, wrists, shoulders, hip, knees and ankles). Strength training (25 min) will comprise upper and lower body exercises performed with external weights, which will be tailored to the individual’s functional capacity through Brzycki equation for the estimation of 1-RM (repetition maximum) at baseline and at the end of every month, to ensure an appropriate training stimulus. In all strength tests subjects will be encouraged verbally to perform each exercise as forcefully as possible in a standardized form. In the three first months exercises will be performed with light loads (40–60% 1-RM) to ensure an appropriate adaption to resistance exercise and thereafter loads, if they are well tolerated, will be increased to 65–70% 1-RM for additional benefits.

Table 2 Programation of the intervention for the 13th week

Balance training (10 min) will include exercises in progressing difficulty starting by decreasing arm support (with 2 arms at first, with one hand, and finally none if possible) along with decreasing base of support (both feet together, semi-tandem and tandem positions) and increasing complexity of movements as to challenge participants’ balance as they progress. Exercises will be varied through the period: weight transfer from one leg to another, walking with small obstacles, proprioceptive exercises and stepping practice. Sessions will finish with 5 min of cooling down by stretching, breathing and relaxing exercises.

Walking retraining will also be implemented through individualized recommendations regarding distance and intensity to perform on their own in addition to the supervised sessions. According to ACSM/AHA guidelines [56], exercise intensity will be monitored using a category-ratio 0–10 scale for physical exertion and breathlessness (Borg CR10 scale) [57]. Participants will be instructed to walk at a moderate intensity, equivalent to a 5–6 on the CR10 scale, with a target goal of achieving at least 22 min/day at the end of the 6 months period. Walking retraining will initially begin with light intensity activity for short periods of time, which gradually will be increased in intensity and duration over the 6 months period.

Finally, attendance to the program may be suspended due to a hospitalization, injury, or any other health events. Evaluation for re-engaging the exercitation will depend on the functional impact of the illness and on any activity limitation prescriptions that may provide the participant’s health care team. Irrespective of the week of the intervention that a suspension may occur, all restarts will be conducted in a supervised and progressive way.

Outcome measures

The primary outcome measure will be the difference in function between intervention and control group assessed by changes in summary ordinal score on the Short Physical Performance Battery [58] (SPPB). SPPB consists of three tests: balance, gait ability and leg strength. The score for each test is given in categorical modality (0–4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best). The SPPB has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality. A total score of less than 10 points indicates frailty and a high risk of disability and falls. 1 point change in the total score has demonstrated to be of clinical relevance [59, 60].

The following parameters will be also recorded: age, gender, socioeconomic situation, marital status, Barthel index [51], MEC-35 [52], Lubben Social Network Scale (LSNS-6) [61], Tilburg Frail index [62], Frailty index [63], and Charlson [64] index. Anthropometric data will include body mass index (BMI) and waist-hip ratio; fat mass percentage will be measured using a portable bio-electrical impedance analyzer (Bodystat BIA Quadscan 4000) [65].

Functional examination will include the following (Table 3): Senior Fitness Test [66], instrumented Timed Up and Go test [67] (iTUG; BTS Biomedical G-WALK triaxial accelerometer and gyroscope), comfortable and fast walking speed [68], bilateral handgrip strength test [69] (Jamar dynamometer), Berg balance test [70], static balance and fall-risk by stabilometer [71] (Biodex Balance System SD), as well as active and sedentary periods during everyday life recorded with an accelerometer (Actigraph GT3X model (Actigraph LLC, Pensacola, FL, USA)) that will be worn on the hip with a belt for a 7 day period. The device will be set to quantify the number of steps taken per day. In line with that, active-period intensities will be classified following the criteria developed by Freedson et al. [72] as light, moderate or vigorous intensity and measured in minutes performed in each intensity.

Table 3 Functional assessment tests

Cognitive and emotional assessment will be determined by the following (Table 4): Clinical Dementia Rating [73] (CDR), Montreal Cognitive Assessment (MoCA) [74], Symbol Digit Modalities Test (SDMT) [75] and Anxiety and Depression Goldberg Scale [76]. Health related quality of life will be assessed by the questionnaire EQ-5D-5 L [77].

Table 4 Cognitive and Functional assessment tests

Blood samples will be obtained and stored at − 80 °C. Biomarkers will be measured according to standard laboratory protocols at the Physiology laboratory in the University of the Basque Country using an ELISA kit (ChemiKine TM; Millipore, Temecula, CA) following the manufacturer’s instructions. Thus, myostatin [78], irisin [79], interleukin 6 [46] and BDNF [49] will be measured (Table 5).

Table 5 Biomarkers that will be analysed in the study

Finally, we will also record the number of falls, visits to the emergency service, hospital admissions and length of hospital stay.

Safety assessments

All co-existing diseases or conditions related with the intervention will be treated in accordance with prevailing medical practice and will be reported as an adverse event.

Power and sample size

Sample size has been calculated to detect minimal significant effects on the variable of physical performance (SPPB) [80, 81]: accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 86 individuals are required in order to detect a difference equal to or greater than 1 unit in the SPPB (SD = 2.34). It has been increased the sample size in an additional 20% (loses during follow-up) and 5% (mortality). The resultant sample size is determinate in 114 individuals, therefore 57 individuals per group (intervention and control group).

Statistical considerations

The IBM SPSS Statistics 23 statistical software package (SPSS, Inc., Chicago, IL) will be used to analyse the data. Intention to treat analyses will be performed. The normal distribution of the data will be evaluated using the Kolmogorov-Smirnov test. Continuous variables will be expressed as mean (SD) when normally distributed and as median with interquartile range (IQR) when not. Categorical variables will be expressed as frequency counts and percentages. Statistical comparisons at baseline will be performed using appropriate statistical tests according to the type and distribution of the data: t test or Mann–Whitney U-test for continuous variables and Chi-squared test for categorical variables. The intervention-related effects will be performed using appropriate statistical tests according to the type and distribution of the data: an analysis of variance (ANOVA) or Friedman test with repeated measures (0, 3 and 6 months). When a significant F value is obtained, LSD post hoc procedures will be used to evaluate pairwise differences. p < 0.05 will be considered to be statistically significant. Furthermore, an analysis of covariance (ANCOVA) will be done to compare the data between intervention and control groups, considering as co-variables baseline measurements, as well as other variables as age or gender.

Trial status

The trial is currently being set up with participant recruitment. Recruitment will cease when 114 participants have been randomized; it is expected this target will be reached by June 2017.

Discussion

This is a multicenter study designed to ascertain if a supervised multicomponent exercise program carried out in long-term nursing care centers improves or maintains functionality, sedentary behaviors, cognitive and emotional status and biological markers related to frailty when compared with a control population that receives usual care. To our knowledge, an exercise program carried out in nursing home elderly population has not been studied before from a so broad perspective, taking into account all together functional, cognitive, emotional and biochemical conditions. The current lack of definitive evidence on whether ageing related functional deterioration can be effectively prevented by physical exercise in institutionalized elders represents a potential obstacle to the development of guidelines for geriatric clinicians and policymakers that would also report in increasing health-related quality of life for a prevalent and clinically-relevant population. Furthermore, the World Health Organization (WHO) has recently published an Action Plan for the Prevention and Control of Noncommunicable Diseases in the WHO European Region 2016–2025, where it is highlighted the importance of introducing systematic musculoskeletal health programs for older people, including those living in residential care [82]. Moreover, long-term nursing home residents have been identified as a particularly vulnerable group where the above mentioned plan should direct its actions through an early intervention to restore and maintain functionality.

The exercise program that is described in this protocol has been designed to be feasible, easy to implement and potentially delivered in any nursing home settings, which may have direct clinical applications. We previous reported [83] that a similar multicomponent exercise program is feasible, well tolerated and pleasantly welcomed by individuals living in long-term care facilities. Furthermore, improvements in functional status were observed in those participants that took part in the program, particularly in gait ability, balance and aerobic capacity. These findings are in line with other studies carried out in nursing homes, indicating that the exercise programs can benefit functional performance, well being and cognition of the residents [8488]. Nevertheless, to date few randomized clinical trials have been conducted in institutionalized elders, and normally these trials study heterogeneous interventions (sometimes poorly explained), while our study allows the extrapolation of results and the implementation of the program to any other nursing home through a well-defined methodology.

Finally, if the described multicomponent exercise program proves to report benefits in terms of functional, sedentary behavior, cognitive and emotional status, as well as knowledge on the response of biological markers to physical activity, the findings could provide evidence suggesting the need to augment the standard physical practice prescribed at nursing homes in the elder population. Otherwise, failure to reject the null hypothesis would suggest that the progression of the decline associated with the aging process in at-risk persons continues on to disability, despite any potential benefits from physical activity. This would be an important study outcome as well and implies that efforts to hold back the process of disablement in this population should be directed elsewhere.

The study of whether multicomponent exercise program can improve or maintain functionality, sedentary behaviors, cognitive and emotional status and biological markers related with frailty in nursing home elders is nowadays an unanswered question that is of major importance to public health and social policy. It is expected that the results of this research will guide clinical practice in nursing home settings, so that clinicians and policymakers can provide more evidence-based practice for the management of institutionalized elder people.

Abbreviations

ACSM:

American College of sport medicine

AHA:

American heart association

ANZCTR:

Australian and New Zealand clinical trials registry

BDNF:

Brain-derived neural factor

BMI:

Body mass index

CDR:

Clinical dementia rating

CONSORT:

Consolidated Standards of reporting trials

CRP:

C-Reactive protein

EQ-5D-5 L:

EuroQol five-dimensional questionnaire

IAGG:

International association of gerontology and geriatrics

IANA:

International academy of nutrition and aging

IL-1Ra:

Interleukin 1 reception antagonist

IL-6:

Interleukin 6

IQR:

InterQuartile range

iTUG:

Instrumented timed up and go test

LSNS:

Lubben social network scale

MEC-35:

Cognition mini-exam of lobo

MoCA:

Montreal cognitive assessment

RM:

Repetition maximum

SDMT:

Symbol digit modalities test

SPPB:

Short physical performance battery

WHO:

World health organisation

References

  1. Scully T. Demography: to the limit. Nature. 2012;492:2. doi:10.1038/492S2a.

    Article  Google Scholar 

  2. World Health Organization. Global Age-friendly Cities: A Guide. Geneva: WHO press; 2007.

    Google Scholar 

  3. Cesari M, Vellas B, Gambassi G. The stress of aging. Exp Gerontol. 2013;48:451–6. doi:10.1016/j.exger.2012.10.004.

    Article  PubMed  Google Scholar 

  4. World Health Organization. Good Health Adds Life to Years: Global Brief for World Health Day 2012. Geneva: WHO press; 2012.

    Google Scholar 

  5. Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015;385(9968):e7–9. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61595-6/abstract.

  6. Collard RM, Boter H, Schoevers RA, et al. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012;60(8):1487–92. doi:10.1111/j.1532-5415.2012.04054.x.

    Article  PubMed  Google Scholar 

  7. Santos-Eggimann B, Cuénoud P, Spagnoli J, et al. Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries. J Gerontol A Biol Sci Med Sci. 2009;64(6):675–81. doi:10.1093/gerona/glp012.

    Article  PubMed  Google Scholar 

  8. Rodriguez-Manas L, Feart C, Mann G, et al. Searching for an operational definition of frailty: A Delphi method based consensus statement: The frailty operative definition-consensus conference project. J Gerontol A Biol Sci Med Sci. 2013;68(1):62–7. doi:10.1093/gerona/gls119.

    Article  PubMed  Google Scholar 

  9. Robertson DA, Savva GM, Kenny RA. Frailty and cognitive impairment--a review of the evidence and causal mechanisms. Ageing Res Rev. 2013;12(4):840–51. doi:10.1016/j.arr.2013.06.004.

    Article  PubMed  Google Scholar 

  10. Bernal-Lopez C, Potvin O, Avila-Funes JA. Frailty is associated with anxiety in community-dwelling elderly adults. J Am Geriatr Soc. 2012;60(12):2373–4. doi:10.1111/jgs.12014.

    Article  PubMed  Google Scholar 

  11. St. John PD, Tyas SL, Montgomery PR. Depressive symptoms and frailty. Int J Geriatr Psychiatry. 2013;28(6):607–14. doi:10.1002/gps.3866.

    Article  PubMed  Google Scholar 

  12. Gale CR, Cooper C, Deary IJ, et al. Psychological well-being and incident frailty in men and women: the English Longitudinal Study of Ageing. Psychol Med. 2014;44(4):697–706. doi:10.1017/S0033291713001384.

    Article  CAS  PubMed  Google Scholar 

  13. Mhaolain AM, Gallagher D, Crosby L, et al. Frailty and quality of life for people with Alzheimer’s dementia and mild cognitive impairment. Am J Alzheimers Dis Other Demen. 2012;27(1):48–54. doi:10.1177/1533317511435661.

    Article  PubMed  Google Scholar 

  14. Rizzoli R, Reginster JY, Arnal JF, et al. Quality of life in sarcopenia and frailty. Calcif Tissue Int. 2013;93(2):101–20. doi:10.1007/s00223-013-9758-y.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Kelaiditi E, Cesari M, Canevelli M, et al. Cognitive frailty: rational and definition from an (I.A.N.A./I.A.G.G.) international consensus group. J Nutr Health Aging. 2013;17(9):726–34. doi:10.1007/s12603-013-0367-2.

    Article  CAS  PubMed  Google Scholar 

  16. Theou O, Stathokostas L, Roland KP, et al. The effectiveness of exercise interventions for the management of frailty: a systematic review. J Aging Res. 2011;2011:569194. doi:10.4061/2011/569194.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Cadore EL, Rodriguez-Manas L, Sinclair A, et al. 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(2):105–14. doi:10.1089/rej.2012.1397.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Buford TW, Anton SD, Clark DJ, et al. Optimizing the benefits of exercise on physical function in older adults. PM R. 2014;6(6):528–43. doi:10.1016/j.pmrj.2013.11.009.

    Article  PubMed  Google Scholar 

  19. Gine-Garriga M, Roque-Figuls M, Coll-Planas L, et al. 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(4):753–69. doi:10.1016/j.apmr.2013.11.007.

    Article  PubMed  Google Scholar 

  20. Tarazona-Santabalbina FJ, Gómez-Cabrera MC, Pérez-Ros P, et al. A multicomponent exercise intervention that reverses frailty and improves cognition, emotion, and social networking in the community-dwelling frail elderly: a randomized clinical trial. J Am Med Dir Assoc. 2016;17(5):426–33. doi:10.1016/j.jamda.2016.01.019.

    Article  PubMed  Google Scholar 

  21. Pahor M, Guralnik JM, Ambrosius WT, et al. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. Jama. 2014;311(23):2387–96. doi:10.1001/jama.2014.5616.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Cadore EL, Moneo ABB, Mensat MM, et al. Positive effects of resistance training in frail elderly patients with dementia after long-term physical restraint. AGE. 2014;36(2):801–11. doi:10.1007/s11357-013-9599-7.

    Article  PubMed  Google Scholar 

  23. Colley RC, Garriguet D, Janssen I, et al. Physical activity of Canadian adults: accelerometer results from the 2007–2009 Canadian Health Measures Survey. Health Reports, Statistics Canada. 2011;Catalogue 82-003-XPE. http://www.statcan.gc.ca/pub/82-003-x/2011001/article/11396-eng.pdf. Accessed 21 Feb 2017.

  24. Sardinha LB, Santos DA, Silva AM, et al. Breaking-up sedentary time is associated with physical function in older adults. J Gerontol A Biol Sci Med Sci. 2015;70(1):119–24. doi:10.1093/gerona/glu193.

    Article  PubMed  Google Scholar 

  25. Cart LRSM. Letter to the editor: standardized use of the terms “sedentary” and “sedentary behaviours”. Appl Physiol Nutr Metab. 2012;37(3):540–2. doi:10.1139/h2012-024.

    Article  Google Scholar 

  26. Shiroma EJ, Freedson PS, Trost SG, et al. Patterns of accelerometer-assessed sedentary behavior in older women. JAMA. 2013;310(23):2562–3. doi:10.1001/jama.2013.278896.

    Article  CAS  PubMed  Google Scholar 

  27. De Rezende LFM, Rey-Lopez JP, Matsudo VK, et al. Sedentary behavior and health outcomes among older adults: a systematic review. BMC Public Health. 2014;14(1):333. doi:10.1186/1471-2458-14-333.

    Article  PubMed  Google Scholar 

  28. Davis MG, Fox KR, Stathi A, et al. Objectively measured sedentary time and lower extremity function in older adults. J Aging Phys Act. 2014;22(4):474–81. http://0-dx-doi-Org.brum.beds.ac.uk/10.1123/JAPA.2013-0042.

    Article  PubMed  Google Scholar 

  29. Santos DA, Silva AM, Baptista F, et al. Sedentary behavior and physical activity are independently related to functional fitness in older adults. Exp Gerontol. 2012;47:908–12. doi:10.1016/j.exger.2012.07.011.

    Article  PubMed  Google Scholar 

  30. Chastin SFM, Ferriolli E, Stephens NA, et al. Relationship between sedentary behaviour, physical activity, muscle quality and body composition in healthy older adults. Age Ageing. 2012;41:111–4. doi:10.1093/ageing/afr075.

    Article  PubMed  Google Scholar 

  31. McDermott MM, Liu K, Ferrucci L, et al. Greater sedentary hours and slower walking speed outside the home predict faster declines in functioning and adverse calf muscle changes in peripheral arterial disease. J Am Coll Cardiol. 2011;57(23):2356–64. doi:10.1016/j.jacc.2010.12.038.

    Article  PubMed  PubMed Central  Google Scholar 

  32. Cawthon PM, Blackwell TL, Cauley JA, et al. Objective assessment of activity, energy expenditure, and functional limitations in older men: the Osteoporotic Fractures in Men study. J Gerontol A Biol Sci Med Sci. 2013;68(12):1518–24. doi:10.1093/gerona/glt054.

    Article  PubMed  PubMed Central  Google Scholar 

  33. Rosenberg DE, Bellettiere J, Gardiner PA, et al. Independent Associations Between Sedentary Behaviors and Mental, Cognitive, Physical, and Functional Health Among Older Adults in Retirement Communities. J Gerontol A Biol Sci Med Sci. 2016;71(1):78–83. doi:10.1093/gerona/glv103.

    Article  PubMed  Google Scholar 

  34. Dunlop DD, Song J, Arntson EK, et al. Sedentary time in U.S. older adults associated with disability in activities of daily living independent of physical activity. J Phys Act Health. 2015;12(1):93–101. doi:10.1123/jpah.2013-0311.

    Article  PubMed  Google Scholar 

  35. Davis MG, Fox KR, Stathi A, et al. Objectively measured sedentary time and its association with physical function in older adults. J Aging Phys Act. 2014;22(4):474–81. doi:10.1123/japa.2013-0042.

    Article  PubMed  Google Scholar 

  36. Lucas M, Mekary R, Pan A, et al. Relation between clinical depression risk and physical activity and time spent watching television in older women: a 10-year prospective follow-up study. Am J Epidemiol. 2011;174(9):1017–27. doi:10.1093/aje/kwr218.

    Article  PubMed  PubMed Central  Google Scholar 

  37. Hamer M, Stamatakis E. Prospective study of sedentary behavior, risk of depression, and cognitive impairment. Med Sci Sports Exerc. 2014;46(4):718–23. doi:10.1249/MSS.0000000000000156.

    Article  PubMed  PubMed Central  Google Scholar 

  38. Kesse-Guyot E, Charreire H, Andreeva VA, et al. Cross-sectional and longitudinal associations of different sedentary behaviors with cognitive performance in older adults. PLoS One. 2012;7(10), e47831. doi:10.1371/journal.pone.0047831.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  39. Fraile-Bermúdez AB, Kortajarena M, Zarrazquin I, et al. Relationship between physical activity and markers of oxidative stress in independent community-living elderly individuals. Exp Gerontol. 2015;70:26–31. doi:10.1016/j.exger.2015.07.005.

    Article  PubMed  Google Scholar 

  40. Vallance JK, Boyle T, Courneya KS, et al. Associations of objectively assessed physical activity and sedentary time with health-related quality of life among colon cancer survivors. Cancer. 2014;120(18):2919–26. doi:10.1002/cncr.28779.

    Article  PubMed  Google Scholar 

  41. George SM, Alfano CM, Groves J, et al. Objectively measured sedentary time is related to quality of life among cancer survivors. PLoS One. 2014;9(2), e87937. doi:10.1371/journal.pone.0087937.

    Article  PubMed  PubMed Central  Google Scholar 

  42. Balboa-Castillo T, Leon-Munoz LM, Graciani A, et al. Longitudinal association of physical activity and sedentary behavior during leisure time with health-related quality of life in community-dwelling older adults. Health Qual Life Outcomes. 2011;9(1):47. doi:10.1186/1477-7525-9-47.

    Article  PubMed  PubMed Central  Google Scholar 

  43. Berrut G, Andrieu S, De Carvalho IA, et al. Promoting access to innovation for frail old persons. J Nutr Health Aging. 2013;17(8):688–93. doi:10.1007/s12603-013-0039-2.

    Article  CAS  PubMed  Google Scholar 

  44. Erusalimsky JD, Grillari J, Grune T, et al. In Search of ‘Omics’-Based Biomarkers to Predict Risk of Frailty and Its Consequences in Older Individuals: The FRAILOMIC Initiative. Gerontology. 2015;62(2):182–90. doi:10.1159/000435853.

    Article  PubMed  Google Scholar 

  45. Walston J, McBurnie MA, Newman A, et al. Frailty and activation of the inflammation and coagulation systems with and without clinical comorbidities: results from the Cardiovascular Health Study. Arch Intern Med. 2002;162(20):2333–41. doi:10.1001/archinte.162.20.2333.

    Article  PubMed  Google Scholar 

  46. Cesari M, Penninx BW, Pahor M, et al. Inflammatory markers and physical performance in older persons: the InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2004;59(3):M242–8. doi:10.1093/gerona/59.3.M242.

    Article  Google Scholar 

  47. Ferrucci L, Penninx BW, Volpato S, et al. Change in Muscle Strength Explains Accelerated Decline of Physical Function in Older Women With High Interleukin‐6 Serum Levels. J Am Geriatr Soc. 2002;50(12):1947–54. doi:10.1046/j.1532-5415.2002.50605.x.

    Article  PubMed  Google Scholar 

  48. Puts MTE, Lips PTAM, Deeg DJH. Static and dynamic measures of frailty predicted decline in performance-based and self-reported physical functioning. J Clin Epidemiol. 2005;58(11):1188–98. doi:10.1016/j.jclinepi.2005.03.008.

    Article  CAS  PubMed  Google Scholar 

  49. De Melo Coelho FG, Gobbi S, Andreatto CAA, et al. Physical exercise modulates peripheral levels of brain-derived neurotrophic factor (BDNF): a systematic review of experimental studies in the elderly. Arch Gerontol Geriatr. 2013;56(1):10–5. doi:10.1016/j.archger.2012.06.003.

    Article  Google Scholar 

  50. Rodriguez-Larrad A, Arrieta H, Yanguas J, Markotegi M, Irazusta A, Gil SM. Multi-component exercise training in elderly day care centers: a pilot study. 21st Annual Congress of the European College of Sport Science. Book of Abstracts. ISBN 978-3-00-053383-9. 2016. p. 204.

  51. Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64–7. doi:10.3109/09638288809164105.

    Article  CAS  PubMed  Google Scholar 

  52. Lobo A, Saz P, Marcos G, et al. Revalidación y normalización del Mini-Examen Cognoscitivo (primera versión en castellano del Mini-Mental Status Examination) en la población general geriátrica. Med Clin (Barc). 1999;112(20):767–74.

    CAS  Google Scholar 

  53. Binder EF, Schechtman KB, Ehsani AA, et al. Effects of exercise training on frailty in community‐dwelling older adults: results of a randomized, controlled trial. J Am Geriatr Soc. 2002;50(12):1921–8. doi:10.1046/j.1532-5415.2002.50601.x.

    Article  PubMed  Google Scholar 

  54. McPhate L, Simek EM, Haines TP. Program-related factors are associated with adherence to group exercise interventions for the prevention of falls: a systematic review. J Physiother. 2013;59(2):81–92. doi:10.1016/S1836-9553(13)70160-7.

    Article  PubMed  Google Scholar 

  55. Chodzko-Zajko WJ, Proctor DN, Fiatarone-Singh MA, for the American College of Sports Medicine Position Stand, et al. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009;41:1510–30. doi:10.1249/MSS.0b013e3181a0c95c.

    Article  PubMed  Google Scholar 

  56. Nelson ME, Rejeski WJ, Blair SN, et al. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Circulation. 2007;116(9):1094–105. doi:10.1161/CIRCULATIONAHA.107.185650.

    Article  PubMed  Google Scholar 

  57. Guralnik JM, Simonsick EM, Ferrucci L, 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(2):M85–94. doi:10.1093/geronj/49.2.M85.

    Article  CAS  PubMed  Google Scholar 

  58. Borg G. Perceived exertion and pain scales. Champaign: Human Kinetics; 1988.

    Google Scholar 

  59. Guralnik JM, Ferrucci L, Simonsick EM, et al. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995;332(9):556–61. doi:10.1056/NEJM199503023320902.

    Article  CAS  PubMed  Google Scholar 

  60. Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, 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 A Biol Sci Med Sci. 2000;55(4):M221–31. doi:10.1093/gerona/55.4.M221.

    Article  CAS  PubMed  Google Scholar 

  61. Lubben J, Blozik E, Gillmann G, et al. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006;46:503–13. doi:10.1093/geront/46.4.503.

    Article  PubMed  Google Scholar 

  62. Gobbens RJ, Van Assen MA, Luijkx KG, et al. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 2010;11(5):344–55. doi:10.1016/j.jamda.2009.11.003.

    Article  PubMed  Google Scholar 

  63. Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):M146–56. doi:10.1093/gerona/56.3.M146.

    Article  CAS  PubMed  Google Scholar 

  64. Charlson M, Szatrowski TP, Peterson J, et al. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47(11):1245–51. doi:10.1016/0895-4356(94)90129-5.

    Article  CAS  PubMed  Google Scholar 

  65. Scafoglieri A., Predicting appendicular lean and fat mass with bioelectrical impedance analysis in older adults with physical function decline e The PROVIDE study. Clin Nutrition. 2016;Article in press. doi: http://0-dx-doi-org.brum.beds.ac.uk/10.1016/j.clnu.2016.04.026.

  66. Rikli RE, Jones CJ. Senior fitness test. Champaign: Human Kinetics; 2001. ISBN 0-7360-3356-4.

    Google Scholar 

  67. Mathias S, Nayak US, Isaacs B. Balance in elderly patients: the “get-up and go” test. Arch Phys Med Rehabil. 1986;67(6):387–9.

    CAS  PubMed  Google Scholar 

  68. Bohannon RW, Andrews AW, Thomas MW. Walking speed: reference values and correlates for older adults. J Orthop Sports Phys Ther. 1996;24(2):86–90. doi:10.2519/jospt.1996.24.2.86.

    Article  CAS  PubMed  Google Scholar 

  69. Fess EE. In: Casanova JS, editor. Clinical assessment recommendations. Chicago: American Society of Hand Therapists; 1992. p. 41–5. Grip strength.

    Google Scholar 

  70. Berg KO, Wood-Dauphinée SL, Williams JI, et al. Measuring balance in the elderly: validation of an instrument. Can J Publ Health. 1992;83:S7–S11.

    Google Scholar 

  71. Gusi N, Adsuar JC, Corzo H, et al. Balance training reduces fear of falling and improves dynamic balance and isometric strength in institutionalised older people: a randomised trial. J Physiother. 2012;58(2):97–104. doi:10.1016/S1836-9553(12)70089-9.

    Article  PubMed  Google Scholar 

  72. Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998;30(5):777–81. doi:10.1097/00005768-199805000-00021.

    Article  CAS  PubMed  Google Scholar 

  73. Morris JC. The clinical dementia rating (CDR): current version and scoring rules. Neurology. 1993;43(11):2412–4.

    Article  CAS  PubMed  Google Scholar 

  74. Coen RF, Robertson DA, Kenny RA, et al. Strengths and Limitations of the MoCA for Assessing Cognitive Functioning Findings From a Large Representative Sample of Irish Older Adults. J Geriatr Psychiatry Neurol. 2016;29(1):18–24. doi:10.1177/0891988715598236.

    Article  PubMed  Google Scholar 

  75. Sheridan LK, Fitzgerald HE, Adams KM, et al. Normative Symbol Digit Modalities Test performance in a community-based sample. Arch Clin Neuropsychol. 2006;21(1):23–8. doi:10.1016/j.acn.2005.07.003.

    Article  PubMed  Google Scholar 

  76. Goldberg D, Bridges K, Duncan-Jones P, et al. Detecting anxiety and depression in general medical settings. Br Med J. 1988;297(6653):897–9. doi:10.1136/bmj.297.6653.897.

    Article  CAS  Google Scholar 

  77. Janssen MF, Pickard AS, Golicki D, et al. Measurement properties of the EQ-5D-5 L compared to the EQ-5D-3 L across eight patient groups: a multi-country study. Qual Life Res. 2013;22(7):1717–27. doi:10.1007/s11136-012-0322-4.

    Article  CAS  PubMed  Google Scholar 

  78. Kalinkovich A, Livshits G. Sarcopenia–The search for emerging biomarkers. Ageing Res Rev. 2015;22:58–71.

    Article  CAS  PubMed  Google Scholar 

  79. Boström P, Wu J, Jedrychowski MP, et al. A PGC1-[agr]-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature. 2012;481(7382):463–8.

    Article  PubMed  PubMed Central  Google Scholar 

  80. Perera S, Mody SH, Woodman RC, et al. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006;54(5):743–9. doi:10.1111/j.1532-5415.2006.00701.x.

    Article  PubMed  Google Scholar 

  81. Kwon S, Perera S, Pahor M, et al. What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study). J Nutr Health Aging. 2009;13:538–44. doi:10.1007/s12603-009-0104-z.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  82. World Health Organization. Regional Committee for Europe 66th Session. Action plan for the prevention and control of noncommunicable diseases in the WHO European Region. Copenhagen, Denmark, 12–15 September 2016. http://www.euro.who.int/__data/assets/pdf_file/0011/315398/66wd11e_NCDActionPlan_160522.pdf?ua=1. Accesed 21 Feb 2017.

  83. Arrieta H., Rodriguez-Larrad A., Iturburu M., Kortajarena M., Irazusta J. A pilot trial of multi-component exercise training in older residents in long-term residential care facilities. 21st Annual Congress of the European College of Sport Science. Book of Abstracts. ISBN 978-3-00-053383-9. 2016. p. 204.

  84. Brett L, Traynor V, Stapley P. Effects of physical exercise on health and well-being of individuals living with a dementia in nursing homes: A systematic review. J Am Med Dir Assoc. 2016;17(2):104–16. doi:10.1016/j.jamda.2015.08.016.

    Article  PubMed  Google Scholar 

  85. De Souto Barreto P, Morley JE, Chodzko-Zajko W, et al. Recommendations on physical activity and exercise for older adults living in long-term care facilities: a taskforce report. J Am Med Dir Assoc. 2016;17(5):381–92. doi:10.1016/j.jamda.2016.01.021.

    Article  PubMed  Google Scholar 

  86. Frändin K., Grönstedt H., Helbostad J.L. et al. Long-Term Effects of Individually Tailored Physical Training and Activity on Physical Function, Well-Being and Cognition in Scandinavian Nursing Home Residents: A Randomized Controlled Trial. Gerontology. 2016. doi:10.1159/000443611.

  87. Franzke B, Halper B, Hofmann M, et al. The effect of 6 months of elastic band resistance training, nutritional supplementation or cognitive training on chromosomal damage in institutionalized elderly. Exp Gerontol. 2015;65:16–22. doi:10.1016/j.exger.2015.03.001.

    Article  PubMed  Google Scholar 

  88. Casilda-López J, Torres-Sánchez I, Garzón-Moreno VM, et al. Results of a physical therapy program in nursing home residents: A randomized clinical trial. Rev Esp Geriatr Gerontol. 2014;50(4):174–8. doi:10.1016/j.regg.2014.09.007.

    Article  Google Scholar 

Download references

Acknowledgements

We would like to thank all study participants and their families for their cooperation and their confidence in the research team.

Funding

This research is supported by a grant from the Basque Government (ELKARTEK15/39; N°. EXPT.: KK-2015/00106).

Availability of data and materials

Not applicable.

Authors’ contributions

The protocol was developed by AR, JI, SG, HA, CR, MK, JY and MI. AR, JI, SG, HA and CR prepared the initial manuscript. All authors contributed to and reviewed the final manuscript prior to submission. All authors read and approved the final manuscript.

Competing interests

The authors declare that they have no competing interests.

Consent for publication

Not applicable.

Ethics approval and consent to participate

The present study has been approved by the Committee on Ethics in Research of the University of the Basque Country (Humans Committee Code M10/2016/105; Biological Samples Committee Code M30/2016/106) and has also received a letter of support from the senior administrator of Matia and Caser Residential Care Facilities. Furthermore, the study protocol has been registered under the Australian and New Zealand Clinical Trials Registry (ANZCTR) with the identifier: ACTRN12616001044415 and all participants will provide written informed consent based on documents approved by a university Institutional Review Board. The study will be carried out in accordance with Good Clinical Practice, applicable local regulatory requirements, and the guiding principles of the Declaration of Helsinki. Universal Trial Number U1111-1185-6368.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Ana Rodriguez-Larrad.

Rights and permissions

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Rodriguez-Larrad, A., Arrieta, H., Rezola, C. et al. Effectiveness of a multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: study protocol for a randomized clinical controlled trial. BMC Geriatr 17, 60 (2017). https://0-doi-org.brum.beds.ac.uk/10.1186/s12877-017-0453-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://0-doi-org.brum.beds.ac.uk/10.1186/s12877-017-0453-0

Keywords