Open Access
Tailored prevention of functional decline through a multicomponent exercise program in hospitalized oncogeriatric patients: study protocol for a randomized clinical trial
(Elsevier, 2023) Martínez Velilla, Nicolás; Arrazubi, Virginia; Zambom Ferraresi, Fabíola; Morilla Ruiz, Idoia; López Sáez de Asteasu, Mikel; Ramírez Vélez, Robinson; Zambom Ferraresi, Fabrício; Casa Marín, Antón de la; Ollo Martínez, Iranzu; Gorospe-García, Itziar; Gurruchaga Sotés, Ibon; Galbete Jiménez, Arkaitz; Cedeño Veloz, Bernardo Abel; Martín-Nevado, L.; Izquierdo Redín, Mikel; Vera García, Ruth; Ciencias de la Salud; Osasun Zientziak; Estadística, Informática y Matemáticas; Estatistika, Informatika eta Matematika
BACKGROUND: Cancer mostly affects older adults, causing a wide variety of diagnostic and therapeutic dilemmas. One of the most important moments in cancer patients is the hospitalization period, in which older patients usually remain bedridden for many hours and this may lead to the appearance of sarcopenia and disability. METHODS: We present the research protocol for a randomized controlled trial that will analyze whether an intervention applied to older patients (≥ 65 years) who are hospitalized for acute medical conditions in an Oncology Department improves function. A total of 240 hospitalized older patients will be recruited in the Hospital Universitario de Navarra, Pamplona, Spain, and they will be randomized. The intervention consists of a multicomponent exercise training program that will take place for 4 consecutive days (2 sessions/day). The control group will receive usual hospital care, which will include physical rehabilitation when needed. The primary end point will be the change in functional capacity from baseline to hospital discharge, assessed with the Short Physical Performance Battery (SPPB). Secondary end points will be changes in cognitive and mood status, quality of life, fatigue, strength (dynamic and handgrip), pain, nutrition, length of stay, falls, readmission rate and mortality at 3 months after discharge. RESULTS: Basal data of the patients included in the RCT are described. The foreseen recruitment will not be achieved due to the context of the Covid pandemic and the significantly different responses observed during the clinical trial in oncogeriatric patients compared to our previous experience in older adults hospitalized for medical reasons. DISCUSSION: If our hypothesis is correct and shows that a multicomponent, individualized and progressive exercise program is an effective therapy for improving the capacity of acutely hospitalized older patients compared to usual care, a change in the current system of hospitalization may be justified in oncogeriatric patients.
Open Access
Olfactory characterization and training in older adults: protocol study
(Frontiers Media, 2021) Zambom Ferraresi, Fabíola; Zambom Ferraresi, Fabrício; Fernández Irigoyen, Joaquín; Lachén Montes, Mercedes; Cartas Cejudo, Paz; Lasarte, Juan José; Casares, Noelia; Fernández, Secundino; Cedeño Veloz, Bernardo Abel; Maraví-Aznar, Enrique; Uzcanga-Lacabe, María Itziar; Galbete Jiménez, Arkaitz; Santamaría Martínez, Enrique; Martínez Velilla, Nicolás; Estadística, Informática y Matemáticas; Estatistika, Informatika eta Matematika; Gobierno de Navarra / Nafarroako Gobernua
The aim of this article is to present the research protocol for a prospective cohort study that will assess the olfactory function and the effect of an intervention based on olfactory training in healthy very old adults (≥75 years old). A convenience sample of 180 older people (50% female) will be recruited in three different environments: hospitalized control group (CH) with stable acute illness (n = 60); ambulatory control group (CA) of community-based living (n = 60); and an experimental odor training group (EOT) from nursing homes (n = 60). The odor training (OT) intervention will last 12 weeks. All the volunteers will be assessed at baseline; CA and EOT groups will also be assessed after 12 weeks. The primary end point will be change in olfactory capacity from baseline to 12 weeks period of intervention or control. The intervention effects will be assessed with the overall score achieved in Sniffin Sticks Test (SST) – Threshold, Discrimination, and Identification (TDI) extended version. Secondary end points will be changes in cognitive tasks, quality of life, mood, immune status, and functional capacity. All these measurements will be complemented with an immune fitness characterization and a deep proteome profiling of the olfactory epithelium (OE) cultured ex vivo. The current study will provide additional evidence to support the implementation of olfactory precision medicine and the development of immunomodulatory nasal therapies based on non-invasive procedures. The proposed intervention will also intend to increase the knowledge about the olfactory function in very elderly people, improve function and quality of life, and promote the recovery of the health.
Open Access
Postoperative physical rehabilitation in the elderly patient after emergency surgery: influence on functional, cognitive and quality of live recovery: study protocol for a randomized clinical trial
(BMC, 2024) Esquiroz Lizaur, Irene; Zambom Ferraresi, Fabrício; Zambom Ferraresi, Fabíola; Ollo Martínez, Iranzu; Casa Marín, Antón de la; Martínez Velilla, Nicolás; Recreo Baquedano, Ana; Galbete Jiménez, Arkaitz; González Álvarez, Gregorio; Yárnoz Irazábal, María Concepción; Eguaras Córdoba, Inés; Ciencias de la Salud; Osasun Zientziak; Universidad Pública de Navarra / Nafarroako Unibertsitate Publikoa
Background: the progressive aging of the population has meant the increase in elderly patients requiring an urgent surgery. Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery. These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. We aim to determine whether postoperative physical rehabilitation can prevent functional and cognitive decline and modify the posterior trajectory. Methods/design: this study is a randomized clinical trial, simple blinded, conducted in the Department of Surgery of a tertiary public hospital in Navarra (Hospital Universitario de Navarra), Spain. Patients > = 70 years old undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent physical training programme, which will include progressive and supervised endurance, resistance and balance training for 4 weeks, twice weekly sessions with a total of 8 sessions, and the group control will receive the usual care. The primary outcome measure is the change in functional (SPPB) and cognitive status (Mini-Mental State Examination) and the change of quality of life (EuroQol-5D-VAS) during the study period. The secondary outcomes are postoperative complications, length of stay, delirium, mortality, use of health resources, functional status (Barthel Index and handgrip strength tests), cost per quality-adjusted life year and mininutritional assessment. The data for both the intervention group and the control group will be obtained at four different times: the initial visit during hospital admission and at months 1, 3 and 6 months after hospital discharge. Discussion: If our hypothesis is correct, this project could show that individualized and progressive exercise programme provides effective therapy for improving the functional capacity and achieve a better functional, cognitive and quality of life recovery. This measure, without entailing a significant expense for the administration, probably has an important repercussion both in the short- and long-term recovery, improving care and functional parameters and could determine a lower subsequent need for health resources. To verify this, we will carry out a cost-effectiveness study. The clinical impact of this trial can be significant if we help to modify the traditional management of the elderly patients from an illness model to a more person-centred and functionally oriented perspective. Moreover, the prescription of individualized exercise can be routinely included in the clinical practice of these patients. Trial registration: ClinicalTrials.gov Identifier: NCT05290532. Version 1. Registered on March 13, 2022.
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
Effects of an individualised exercise program in hospitalised older adults with cancer: a randomised clinical trial
(Springer, 2025-01-01) Ferrara, Maria Cristina; Zambom Ferraresi, Fabrício; Castillo, A.; Delgado, Marina; Galbete Jiménez, Arkaitz; Arrazubi, Virginia; Morilla Ruiz, Idoia; Zambom Ferraresi, Fabíola; Fernández González de la Riva, María Luisa; Vera García, Ruth; Martínez Velilla, Nicolás; Ciencias de la Salud; Osasun Zientziak; Estadística, Informática y Matemáticas; Estatistika, Informatika eta Matematika; Institute of Smart Cities - ISC; Universidad Pública de Navarra / Nafarroako Unibertsitate Publikoa
We aimed to examine the effects of an individualised multicomponent exercise program on functional outcomes in hospitalised older patients with cancer. Patients aged ¿ 65 were recruited upon admission to a Medical Oncology Department and randomly allocated to receive a multicomponent exercise training program twice daily for five days or standard hospital care. The primary outcome measure was the change in functional status using the Short Physical Performance Battery. This study allocated 30 patients in the Control group and 28 in the intervention group. The mean age was 74.4 years. The intervention group (n = 14) showed significant improvements vs the Control group (n = 20) in the Short Physical Performance Battery (SPPB) (between-group difference, 1.92; 95% CI = 0.80,3.07), knee extension strength (between-group difference 7.72; 95% CI = 1.83,13.8), as well as a significant reduction in fatigue (between-group difference —26.5; 95% CI = —38.6,—13.9). This individualised exercise program appears to have contributed to improving functional abilities and reducing fatigue in hospitalised older cancer patients.
Open Access
Effects of immersive virtual reality stimulation and/or multicomponent physical exercise on cognitive and functional performance in hospitalized older patients with severe functional dependency: study protocol for a randomized clinical trial
(BioMed Central (BMC), 2024-11-08) Casa Marín, Antón de la; Zambom Ferraresi, Fabíola; Ferrara, Maria Cristina; Ollo Martínez, Iranzu; Galbete Jiménez, Arkaitz; González Glaría, Belén; Moral Cuesta, Débora; Marín Epelde, Itxaso; Chenhuichen, Chenhui; Lorente-Escudero, Marta; Molero-de-Ávila, Ródrigo; García Baztán, Agurne; Zambom Ferraresi, Fabrício; Martínez Velilla, Nicolás; Ciencias de la Salud; Osasun Zientziak; Estadística, Informática y Matemáticas; Estatistika, Informatika eta Matematika; Institute of Smart Cities - ISC; Universidad Pública de Navarra / Nafarroako Unibertsitate Publikoa
Background Hospital-associated functional decline affects nearly one-third of the hospitalized older adults. The aim of this trial is to investigate the effect of a cognitive stimulation intervention provided via immersive virtual reality (IVR), with or without a multicomponent physical exercise intervention (ME) in hospitalized patients aged 75 or older with severe functional dependency at admission (Barthel Index <60 points). Methods This clinical randomized controlled trial will be conducted in the Acute Geriatric Unit of a tertiary hospital in Spain. A total of 212 acute patients will be enrolled according to the following criteria: age ≥75, Barthel Index <60, able to collaborate, expected length of stay ≥5 days, absence of clinical instability and severe dementia (Global Deterioration Scale 7) or other end-stage disease. Patients will be randomly assigned to a control group (CG) or any of the three intervention groups (IG): IVR, ME, or IVR + ME. The IVR group will watch ad-hoc videos showing Spanish regional landscapes and villages, approximately 4 min per day for three consecutive days. The ME group will undergo aerobic and strength exercise for progressive training of the upper and lower limbs. The IVR + ME group will do both cognitive and physical intervention. The primary outcomes will be cognitive and physical measures at discharge. Mood, quality of life, isometric strength, and acceptance of IVR will be also assessed. Discussion This project has the potential to enhance physical and psychological well-being of patients with severe functional dependency hospitalized for acute conditions, using technology. Virtual reality is expected to be favourably perceived by hospitalized older adults. This intervention represents a novelty in the geriatric patients¿ care, comprising IVR and/or ME dispensed within the patient¿s room, and including patients who are commonly excluded from research clinical trials.