Open Access
Effects of short-term multicomponent exercise intervention on muscle power in hospitalized older patients: a secondary analysis of a randomized clinical trial
(Wiley, 2023) Lusa Cadore, Eduardo; Izquierdo Redín, Mikel; Teodoro, Juliana Lopes; Martínez Velilla, Nicolás; Zambom Ferraresi, Fabrício; Moriguchi, Emilio Hideyuki; López Sáez de Asteasu, Mikel; Ciencias de la Salud; Osasun Zientziak
Background: bed rest during hospitalization can negatively impact functional independence and clinical status of older individuals. Strategies focused on maintaining and improving muscle function may help reverse these losses. This study investigated the effects of a short-term multicomponent exercise intervention on maximal strength and muscle power in hospitalized older patients. Methods: this secondary analysis of a randomized clinical trial was conducted in an acute care unit in a tertiary public hospital. Ninety (39 women) older patients (mean age 87.7 ± 4.8 years) undergoing acute-care hospitalization [median (IQR) duration 8 (1.75) and 8 (3) days for intervention and control groups, respectively]) were randomly assigned to an exercise intervention group (n = 44) or a control group (n = 46). The control group received standard care hospital including physical rehabilitation as needed. The multicomponent exercise intervention was performed for 3 consecutive days during the hospitalization, consisting of individualized power training, balance, and walking exercises. Outcomes assessed at baseline and discharge were maximal strength through 1 repetition maximum test (1RM) in the leg press and bench press exercises, and muscle power output at different loads (≤ 30% of 1RM and between 45% and 55% of 1RM) in the leg press exercise. Mean peak power during 10 repetitions was assessed at loads between 45% and 55% of 1RM. Results: at discharge, intervention group increased 19.2 kg (Mean ∆% = 40.4%) in leg press 1RM [95% confidence interval (CI): 12.1, 26.2 kg; P < 0.001] and 2.9 kg (Mean ∆% = 19.7%) in bench press 1RM (95% CI: 0.6, 5.2 kg; P < 0.001). The intervention group also increased peak power by 18.8 W (Mean ∆% = 69.2%) (95% CI: 8.4, 29.1 W; P < 0.001) and mean propulsive power by 9.3 (Mean ∆% = 26.8%) W (95% CI: 2.5, 16.1 W; P = 0.002) at loads ≤30% of 1RM. The intervention group also increased peak power by 39.1 W (Mean ∆% = 60.0%) (95% CI: 19.2, 59.0 W; P < 0.001) and mean propulsive power by 22.9 W (Mean ∆% = 64.1%) (95% CI: 11.7, 34.1 W; P < 0.001) at loads between 45% and 55% of 1RM. Mean peak power during the 10 repetitions improved by 20.8 W (Mean ∆% = 36.4%) (95% CI: 3.0, 38.6 W; P = 0.011). No significant changes were observed in the control group for any endpoint. Conclusions An individualized multicomponent exercise program including progressive power training performed over 3 days markedly improved muscle strength and power in acutely hospitalized older patients.
Open Access
Relative handgrip strength diminishes the negative effects of excess adiposity on dependence in older adults: a moderation analysis
(MDPI, 2020) Ramírez Vélez, Robinson; Pérez Sousa, Miguel A.; García Hermoso, Antonio; Zambom Ferraresi, Fabrício; Martínez Velilla, Nicolás; López Sáez de Asteasu, Mikel; Cano Gutiérrez, Carlos Alberto; Rincón Pabón, David; Izquierdo Redín, Mikel; Ciencias de la Salud; Osasun Zientziak; Universidad Pública de Navarra / Nafarroako Unibertsitate Publikoa
The adverse effects of fat mass on functional dependence might be attenuated or worsened, depending on the level of muscular strength. The aim of this study was to determine (i) the detrimental effect of excess adiposity on dependence in activities of daily living (ADL), and (ii) whether relative handgrip strength (HGS) moderates the adverse effect of excess adiposity on dependence, and to provide the threshold of relative HGS from which the adverse effect could be improved or worsened. A total of 4169 participants (69.3 +/- 7.0 years old) from 244 municipalities were selected following a multistage area probability sampling design. Measurements included anthropometric/adiposity markers (weight, height, body mass index, waist circumference, and waist-to-height ratio (WHtR)), HGS, sarcopenia 'proxy' (calf circumference), and ADL (Barthel Index scale). Moderation analyses were performed to identify associations between the independent variable (WHtR) and outcomes (dependence), as well as to determine whether relative HGS moderates the relationship between excess adiposity and dependence. The present study demonstrated that (i) the adverse effect of having a higher WHtR level on dependence in ADL was moderated by relative HGS, and (ii) two moderation thresholds of relative HGS were estimated: 0.35, below which the adverse effect of WHtR levels on dependency is aggravated, and 0.62, above which the adverse effect of fat on dependency could be improved. Because muscular strength represents a critically important and modifiable predictor of ADL, and the increase in adiposity is inherent in aging, our results underscore the importance of an optimal level of relative HGS in the older adult population.
Open Access
CITA GO-ON study: a community based multidomain lifestyle intervention to prevent cognitive decline: protocol design and recruitment process
(Frontiers Media, 2025-06-16) Tainta, Mikel; Ecay-Torres, Mirian; Barandiaran, Myriam; Estanga, Ainara; López, Carolina; Altuna Azkargorta, Miren; Iriondo, Ane; Saldias, Jon; García-Sebastián, Maite; Cañada, Marta; Arriba, Maria de; Reparaz Escudero, Imanol; López Sáez de Asteasu, Mikel; Izquierdo Redín, Mikel; Balluerka, Nekane; Gorostiaga, Arantxa; Ros, Naia; Soroa, Goretti; Domper, Jara; Gayoso, Lucía; Arrizabalaga-López, María; Etxeberria, Usune; Torres, María Inés; Alberdi, Elena; Capetillo-Zarate, Estibaliz; Mateo-Abad, Maider; Vergara, Itziar; Mar, Javier; Martínez-Lage, Pablo; Ciencias de la Salud; Osasun Zientziak
Introduction: Growing research suggests that dementia is a complex disorder with multiple risk factors and causes. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) demonstrated that lifestyle interventions could confer cognitive benefits. Inspired by this, the GOIZ-ZAINDU (GZ) feasibility study adapted the FINGER approach to the Basque context. Building upon the GZ study, the CITA GO-ON trial aims to enhance and expand the evidence supporting dementia prevention through a multidomain intervention of risk factor management and resilience promotion. Methods: It is a two-year, population-based, randomized controlled trial to prevent cognitive decline in adults aged 60–85 years with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥6, no dementia, and belowthan- expected performance on at least one of three cognitive screening tests. Participants are randomized (1:1) to receive either Regular Health Advice (RHA) or a Multidomain Intervention (MD-Int) that encompasses cognitive training, socio-emotional skills, multicomponent physical exercise, nutritional and culinary intervention, and monitoring for cardiovascular risks, pharmacological drug mismanagement, and comorbidities. The primary outcome is the efficacy of the intervention to reduce the risk of cognitive decline measured by the global composite z-score of the modified Neuropsychological Test Battery over two years. The secondary outcomes measure cost-effectiveness, quality of life, and functional abilities. Blood samples and brain imaging will also be collected to evaluate the effects of the intervention on brain structure and plasma biomarkers. Results: Recruitment has been completed with 1051 participants selected (mean age (standard deviation, SD) of 69.65 (6.36), 58,50 % female, and mean CAIDE (SD) of 7.62 (1.427). The final participant is expected to complete the last study visit by the autumn of 2026. Discussion: The CITA GO-ON Study, as a part of the World-Wide FINGERS network, is designed to validate the efficacy of a multidomain lifestyle intervention for dementia prevention and contribute valuable data to inform public health strategies fostering healthy, active aging.
Open Access
Effects of game-based interventions on functional capacity in acutely hospitalised older adults: results of an open-label non-randomised clinical trial
(Oxford University Press, 2022-01-23) Cuevas Lara, César; López Sáez de Asteasu, Mikel; Ramírez Vélez, Robinson; Izquierdo Redín, Mikel; Zambom Ferraresi, Fabíola; Antoñanzas Valencia, Cristina; Galbete Jiménez, Arkaitz; Zambom Ferraresi, Fabrício; Martínez Velilla, Nicolás; Ciencias de la Salud; Osasun Zientziak; Estadística, Informática y Matemáticas; Estatistika, Informatika eta Matematika; Gobierno de Navarra / Nafarroako Gobernua
Background: Hospitalisation-associated disability due to reduced physical activity levels and prolonged bedrest episodes are highly prevalent in older adults. Objective: To assess the effect of gamified interventions on functional capacity in hospitalised older adults. Methods: A three-armed non-randomised controlled trial with two experimental intervention groups and a control group was conducted in a tertiary public hospital in Navarre, Spain. Participants were allocated to a simple gamification group (SGG) (n = 21), a technology-based gamification group (TGG) (n = 23) or a control group (CG) (n = 26). The end points were changes in functional capacity, muscle strength, cognition, mood status and quality of life. Results: Seventy patients (mean age 86.01 ± 4.27 years old) were included in the study; 29 (41.4%) were women. At discharge, compared to CG, a mean increase of 1.47 points (95%CI, 0.15–2.80 points) and 2.69 points (95%CI, 1.32–4.06 points) was observed (SGG and TGG, respectively) in the SPPB test; as well as an increase of 5.28 points (95%CI, 0.70–9.76 points) in the Barthel Index and 2.03 kg (95%CI, 0.33–3.72 kg) in handgrip strength in the TGG. Regression mediation analyses demonstrated that muscle strength changes (β = 1.30; 95%CI, 0.45–2.14; indirect effect 0.864; 95%CI, 0.09–1.90) significantly mediated the TGG effect on the SPPB score. Conclusions: The TGG intervention programme may provide significant benefits in physical and muscle function over usual care and seems to reverse the functional decline frequently associated with acute hospitalisation in older adults.
Open Access
The impact of loneliness and social isolation on the benefits of an exercise program with hospitalised older adults
(Elsevier, 2024-06-03) Martínez Velilla, Nicolás; López Sáez de Asteasu, Mikel; Zambom Ferraresi, Fabrício; Galbete Jiménez, Arkaitz; Marín Epelde, Itxaso; Ferrara, Maria Cristina; Yanguas-Lezáun, José Javier; Izquierdo Redín, Mikel; Ciencias de la Salud; Osasun Zientziak; Estadística, Informática y Matemáticas; Estatistika, Informatika eta Matematika
Objectives: this study aimed to assess the prevalence and impact of loneliness (De Jong Gierveld scale) and isolation (Lubben scale) on the effects of a hospital-based exercise programme. Design: secondary analysis of a randomised clinical trial. Setting: Acute Geriatric Unit of a tertiary hospital in Spain. Participants: 103 hospitalised older adults. Intervention: individualised multicomponent exercise program (20-minute sessions twice a day for 3 consecutive days). Results: among the 103 randomised patients included in the analysis (both arms included), 58.3% were male, and their mean age was 87.3 (4.5) years. According to the Lubben scale, 15.8% of patients were at risk of isolation, while 62.7% were in a situation of severe or moderate loneliness according to the De Jong Gierveld scale. In the non-isolated group, training showed a substantial positive impact on Geriatric Depression Scale (B = -1.25, 95% CI = -0.24 to -0.27). In the isolated group, all outcomes improved, but only the Quality of Life showed significant changes (B = 35, 95% CI = 4.96-35.8). The SPPB test (B = 1.62, 95% CI = 0.19-3.04) and Quality of Life, (B = 17.1, 95% CI = 1.84-32.3) showed a significant improvement in the non-loneliness exercise group while no differences were found in the loneliness group. Conclusion: despite the high prevalence of loneliness and social isolation, individualised exercise programs provide significant benefits to hospitalised patients, especially in quality of life.
Open Access
Assessing the impact of physical exercise on cognitive function in older medical patients during acute hospitalization: secondary analysis of a randomized trial
(PLoS, 2019) López Sáez de Asteasu, Mikel; Martínez Velilla, Nicolás; Zambom Ferraresi, Fabrício; Casas Herrero, Álvaro; Lusa Cadore, Eduardo; Galbete Jiménez, Arkaitz; Izquierdo Redín, Mikel; Ciencias de la Salud; Osasun Zientziak; Gobierno de Navarra / Nafarroako Gobernua
Background: Acute illness requiring hospitalization frequently is a sentinel event leading to long-term disability in older people. Prolonged bed rest increases the risk of developing cognitive impairment and dementia in acutely hospitalized older adults. Exercise protocols applied during acute hospitalization can prevent functional decline in older patients, but exercise benefits on specific cognitive domains have not been previously investigated. We aimed to assess the effects of a multicomponent exercise intervention for cognitive function in older adults during acute hospitalization. Methods and findings: We performed a secondary analysis of a single-blind randomized clinical trial (RCT) conducted from February 1, 2015, to August 30, 2017 in an Acute Care of the Elderly (ACE) unit in a tertiary public hospital in Navarre (Spain). 370 hospitalized patients (aged ≥75 years) were randomly allocated to an exercise intervention (n = 185) or a control (n = 185) group (usual care). The intervention consisted of a multicomponent exercise training program performed during 5–7 consecutive days (2 sessions/day). The usual care group received habitual hospital care, which included physical rehabilitation when needed. The main outcomes were change in executive function from baseline to discharge, assessed with the dual-task (i.e., verbal and arithmetic) Gait Velocity Test (GVT) and the Trail Making Test Part A (TMT-A). Changes in the Mini Mental State Examination (MMSE) test and verbal fluency ability were also measured after the intervention period. The physical exercise program provided significant benefits over usual care. At discharge, the exercise group showed a mean increase of 0.1 m/s (95% confidence interval [CI], 0.07, 0.13; p < 0.001) in the verbal GVT and 0.1 m/s (95% CI, 0.08, 0.13; p < 0.001) in the arithmetic GVT over usual care group. There was an apparent improvement in the intervention group also in the TMT-A score (−31.1 seconds; 95% CI, −49.5, −12.7 versus −3.13 seconds; 95% CI, −16.3, 10.2 in the control group; p < 0.001) and the MMSE score (2.10 points; 95% CI, 1.75, 2.46 versus 0.27 points; 95% CI, −0.08, 0.63; p < 0.001). Significant benefits were also observed in the exercise group for the verbal fluency test (mean 2.16 words; 95% CI, 1.56, 2.74; p < 0.001) over the usual care group. The main limitations of the study were patients’ difficulty in completing all the tasks at both hospital admission and discharge (e.g., 25% of older patients were unable to complete the arithmetic GVT, and 47% could not complete the TMT-A), and only old patients with relatively good functional capacity at preadmission (i.e., Barthel Index score ≥60 points) were included in the study. Conclusions: An individualized, multicomponent exercise training program may be an effective therapy for improving cognitive function (i.e., executive function and verbal fluency domains) in very old patients during acute hospitalization. These findings support the need for a shift from the traditional (bedrest-based) hospitalization to one that recognizes the important role of maintaining functional capacity and cognitive function in older adults, key components of intrinsic capacity.
Open Access
Chronic effects of different intensities of power training on neuromuscular parameters in older people: a systematic review with meta-analysis
(Springer, 2023) Guimarães, Marcelo Bandeira; Blanco‑Rambo, Eduarda; Vieira, Alexandra Ferreira; López Sáez de Asteasu, Mikel; Pinto, Ronei Silveira; Izquierdo Redín, Mikel; Lusa Cadore, Eduardo; Ciencias de la Salud; Osasun Zientziak
Background Power training (PT) has been shown to be an efective method for improving muscle function, includ‑ ing maximal strength, measured by one-repetition maximum (1RM), and power output in older adults. However, it is not clear how PT intensity, expressed as a percentage of 1RM, afects the magnitude of these changes. The aim of this systematic review (International prospective register of systematic reviews—PROSPERO—registration: CRD42022369874) was to summarize the evidence from randomized clinical trials (RCT) assessing the efects of lowintensity (≤49% of 1RM) and moderate-intensity (50–69% of 1RM) versus high-intensity (≥70% of 1RM) PT on maximal power output and maximal strength in older adults. Methods We included RCTs that examined the efects of diferent intensities of power training on maximum strength and power output in older people. The search was performed using PubMed, LILACS, Embase, and Scopus. Methodological quality was assessed using the preferred reporting items for systematic reviews and meta-analyses (PRISMA 2020 statement checklist), and the quality of evidence was determined using the PEDro scale. Data were analyzed using standardized mean diferences (SMD) with a 95% confdence interval (CI), and random efects models were used for calculations. A signifcance level of p≤0.05 was accepted. Results Three RCTs assessing 179 participants, all of high methodological quality, were included. There were no sig‑ nifcant diferences between diferent PT intensities in terms of power output gains for leg press [SMD=0.130 (95% CI −0.19, 0.45), p=0.425] and knee extension exercises [SMD: 0.016 (95% CI −0.362, 0.395), p=0.932], as well as leg press 1RM increases [SMD: 0.296 (95% CI −0.03, 0.62); p=0.072]. However, high-intensity PT (70–80% of 1RM) was sig‑ nifcantly more efective than low-intensity PT in increasing 1RM for knee extension exercise [SMD: 0.523 (95% CI 0.14, 1.91), p=0.008]. Conclusions PT performed at low-to-moderate intensities induces similar power gains compared to high-inten‑ sity PT (70–80% of 1RM) in older adults. Nonetheless, the infuence of PT intensity on lower-limb strength gains seems to be dependent on the assessed exercise. Cautious interpretation is warranted considering the inclusion of only three studies.
Open Access
Effect of exercise intervention on functional decline in very elderly patients during acute hospitalization: a randomized clinical trial
(American Medical Association, 2018) Martínez Velilla, Nicolás; Casas Herrero, Álvaro; Zambom Ferraresi, Fabrício; López Sáez de Asteasu, Mikel; Lucía, Alejandro; Galbete Jiménez, Arkaitz; García Baztán, Agurne; Alonso Renedo, Javier; González Glaría, Belén; Gonzalo Lázaro, María; Apezteguía Iráizoz, Itziar; Gutiérrez Valencia, Marta; Rodríguez Mañas, Leocadio; Izquierdo Redín, Mikel; Ciencias de la Salud; Osasun Zientziak
Importance: Functional decline is prevalent among acutely hospitalized older patients. Exercise and early rehabilitation protocols applied during acute hospitalization can prevent functional and cognitive decline in older patients. Objective: To assess the effects of an innovative multicomponent exercise intervention on the functional status of this patient population. Design, Setting, and Participants: A single-center, single-blind randomized clinical trial was conducted from February 1, 2015, to August 30, 2017, in an acute care unit in a tertiary public hospital in Navarra, Spain. A total of 370 very elderly patients undergoing acute-care hospitalization were randomly assigned to an exercise or control (usual-care) intervention. Intention-to-treat analysis was conducted. Interventions: The control group received usual-care hospital care, which included physical rehabilitation when needed. The in-hospital intervention included individualized moderate-intensity resistance, balance, and walking exercises (2 daily sessions). Main Outcomes and Measures: The primary end point was change in functional capacity from baseline to hospital discharge, assessed with the Barthel Index of independence and the Short Physical Performance Battery (SPPB). Secondary end points were changes in cognitive and mood status, quality of life, handgrip strength, incident delirium, length of stay, falls, transfer after discharge, and readmission rate and mortality at 3 months after discharge. Results: Of the 370 patients included in the analyses, 209 were women (56.5%); mean (SD) age was 87.3 (4.9) years. The median length of hospital stay was 8 days in both groups (interquartile range, 4 and 4 days, respectively). Median duration of the intervention was 5 days (interquartile range, 0); there was a mean (SD) of 5 (1) morning and 4 (1) evening sessions per patient. No adverse effects were observed with the intervention. The exercise intervention program provided significant benefits over usual care. At discharge, the exercise group showed a mean increase of 2.2 points (95% CI, 1.7-2.6 points) on the SPPB scale and 6.9 points (95% CI, 4.4-9.5 points) on the Barthel Index over the usual-care group. Hospitalization led to an impairment in functional capacity (mean change from baseline to discharge in the Barthel Index of -5.0 points (95% CI, -6.8 to -3.2 points) in the usual-care group, whereas the exercise intervention reversed this trend (1.9 points; 95% CI, 0.2-3.7 points). The intervention also improved the SPPB score (2.4 points; 95% CI, 2.1-2.7 points) vs 0.2 points; 95% CI, -0.1 to 0.5 points in controls). Significant intervention benefits were also found at the cognitive level of 1.8 points (95% CI, 1.3-2.3 points) over the usual-care group. Conclusions and Relevance: The exercise intervention proved to be safe and effective to reverse the functional decline associated with acute hospitalization in very elderly patients. Trial Registration: ClinicalTrials.gov identifier: NCT02300896.
Open Access
Short-term multicomponent exercise impact on muscle function and structure in hospitalized older at risk of acute sarcopenia
(Wiley, 2024-10-13) López Sáez de Asteasu, Mikel; Martínez Velilla, Nicolás; Zambom Ferraresi, Fabrício; García Alonso, Yesenia; Galbete Jiménez, Arkaitz; Ramírez Vélez, Robinson; Lusa Cadore, Eduardo; Izquierdo Redín, Mikel; Ciencias de la Salud; Osasun Zientziak; Estadística, Informática y Matemáticas; Estatistika, Informatika eta Matematika; Gobierno de Navarra / Nafarroako Gobernua
Background. Hospitalization exacerbates sarcopenia and physical dysfunction in older adults. Whether tailored inpatient exercise prevents acute sarcopenia is unknown. This study aimed to examine the effect of a multicomponent exercise programme on muscle and physical function in hospitalized older adults. We hypothesized that participation in a brief tailored exercise regimen (i.e., 3–5 days) would attenuate muscle function and structure changes compared with usual hospital care alone. Methods. This randomized clinical trial with blinded outcome assessment was conducted from May 2018 to April 2021 at Hospital Universitario de Navarra, Spain. Participants were 130 patients aged 75 years and older admitted to an acute care geriatric unit. Patients were randomized to a tailored 3- to 5-day exercise programme (n = 64) or usual hospital care (control, n = 66) consisting of physical therapy if needed. The coprimary endpoints were between-group differences in changes in short physical performance battery (SPPB) score and usual gait velocity from hospital admission to discharge. Secondary endpoints included changes in rectus femoris echo intensity, cross-sectional area, thickness and subcutaneous and intramuscular fat by ultrasound. Results. Among 130 randomized patients (mean [SD] age, 87.7 [4.6] years; 57 [44%] women), the exercise group increased their mean SPPB score by 0.98 points (95% CI, 0.28–1.69 points) and gait velocity by 0.09 m/s (95% CI, 0.03–0.15 m/s) more than controls (both p < 0.01). No between-group differences were observed in any ultrasound muscle outcomes. There were no study-related adverse events. Conclusions. Three to 5 days of tailored multicomponent exercise provided functional benefits but did not alter muscle or fat architecture compared with usual hospital care alone among vulnerable older patients. Brief exercise may help prevent acute sarcopenia during hospitalization.
Open Access
Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial
(BioMed Central, 2019) Casas Herrero, Álvaro; Antón Rodrigo, Iván; Zambom Ferraresi, Fabrício; López Sáez de Asteasu, Mikel; Martínez Velilla, Nicolás; Elexpuru Estomba, Jaione; Marín Epelde, Itxaso; Ramón Espinoza, Fernanda; Petidier Torregrosa, Roberto; Sánchez Sánchez, Juan Luis; Ibáñez Beroiz, Berta; Izquierdo Redín, Mikel; Ciencias de la Salud; Osasun Zientziak; Gobierno de Navarra / Nafarroako Gobernua
Background: The benefit of physical exercise in ageing and particularly in frailty has been the aim of recent research. Moreover, physical activity in the elderly is associated with a decreased risk of mortality, of common chronic illnesses (i.e. cardiovascular disease or osteoarthritis) and of institutionalization as well as with a delay in functional decline. Additionally, very recent research has shown that, despite its limitations, physical exercise is associated with a reduced risk of dementia, Alzheimer disease or mild cognitive decline. Nevertheless, the effect of physical exercise as a systematic, structured and repetitive type of physical activity, in the reduction of risk of cognitive decline in the elderly, is not very clear. The purpose of this study aims to examine whether an innovative multicomponent exercise programme called VIVIFRAIL has benefits for functional and cognitive status among pre-frail/frail patients with mild cognitive impairment or dementia. Methods/design: This study is a multicentre randomized clinical trial to be conducted in the outpatient geriatrics clinics of three tertiary hospitals in Spain. Altogether, 240 patients aged 75 years or older being capable of and willing to provide informed consent, with a Barthel Index ≥ 60 and mild cognitive impairment or mild dementia, pre-frail or frail and having someone to help to supervise them when conducting the exercises will be randomly assigned to the intervention or control group. Participants randomly assigned to the usual care group will receive normal outpatient care, including physical rehabilitation when needed. The VIVIFRAIL multicomponent exercise intervention programme consists of resistance training, gait re-training and balance training, which appear to be the best strategy for improving gait, balance and strength, as well as reducing the rate of falls in older individuals and consequently maintaining their functional capacity during ageing. The primary endpoint is the change in functional capacity, assessed with the Short Physical Performance Battery (1 point as clinically significant). Secondary endpoints are changes in cognitive and mood status, quality of life (EQ-5D), 6-m gait velocity and changes in gait parameters (i.e. gait velocity and gait variability) while performing a dual-task test (verbal and counting), handgrip, maximal strength and power of the lower limbs as well as Barthel Index of independence (5 points as clinically significant) at baseline and at the 1-month and 3-month follow-up. Discussion: Frailty and cognitive impairment are two very common geriatric syndromes in elderly patients and are frequently related and overlapped. Functional decline and disability are major adverse outcomes of these conditions. Exercise is a potential intervention for both syndromes. If our hypothesis is correct, the relevance of this project is that the results can contribute to understanding that an individualized multicomponent exercise programme (VIVIFRAIL) for frail elderly patients with cognitive impairment is more effective in reducing functional and cognitive impairment than conventional care. Moreover, our study may be able to show that an innovative individualized multicomponent exercise prescription for these high-risk populations is plausible, having at least similar therapeutic effects to other pharmacological and medical prescriptions.