Frailty

This randomized, double-blind, placebo-controlled clinical trial will investigate whether 10 weeks of CoQ10 supplementation can improve biological resilience and functional health in community-dwelling adults aged 65 years or older with signs of reduced biological resilience or prefrailty. Participants will be randomly assigned in a 1:1 ratio to receive either 200 mg of CoQ10 daily or matching placebo for 10 weeks. The study will assess the effects of CoQ10 supplementation on mitochondrial functional resilience, chronic low-grade inflammation, metabolic health, physical performance, cognitive function, and objective measures of skin aging. The study will also investigate whether baseline biological and functional characteristics can identify individuals who are more likely to benefit from CoQ10 supplementation. An exploratory aim is to develop a multidimensional composite index of biological resilience integrating molecular, biochemical, functional, and clinical measures of aging. The study will provide evidence on whether a mitochondria-targeted intervention with CoQ10 may represent a potential strategy for improving functional resilience and reducing features of prefrailty in older adults.

The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium. The main objective aims to answer: What is the incidence of POD after gastroesophageal cancer surgery.

The goal of this clinical trial is to test the effects of MitoQ supplementation in older adults and frail older adults with physical dysfunction and/or cognitive dysfunction. The main question\[s\] it aims to answer are: * To compare vascular function, oxidative stress levels, and physical and cognitive function among older adults and frail older adults with physical and cognitive dysfunction * To determine whether MitoQ supplementation has the potential to improve vascular function in central and cerebral vessels * To determine whether MitoQ supplementation can enhance physical and cognitive capabilities.

This study aims to explore the relationships between frailty, daily physical activity, sleep quality, and Traditional Chinese Medicine (TCM) constitutions among older adults in Taiwan. In the trial phase, a randomized controlled trial will be conducted specifically for pre-frail older adults. Participants will be randomly assigned to either the exercise training group (Vivifrail program) or the integrated group combining exercise with daytime and sleep-improving acupoint stimulation. The study evaluates the combined efficacy of these non-invasive interventions on reducing frailty severity, improving sleep, and enhancing daily physical functions.

Frailty is a major predictor of adverse outcomes following coronary artery bypass grafting (CABG), being associated with increased postoperative complications, prolonged hospitalization, delayed functional recovery, and reduced quality of life. Although minimally invasive coronary surgery (MICS) through left minithoracotomy has been associated with reduced surgical trauma and faster recovery in selected patients, its benefits have not been evaluated in a randomized trial specifically involving frail patients. The MINI FRAGILE trial is a prospective, multicenter, randomized, open-label clinical trial designed to compare minimally invasive CABG performed through left anterior minithoracotomy with conventional median sternotomy in patients aged 60 years or older with pre-frailty or frailty undergoing surgical coronary revascularization. Eligible participants will be randomized in a 1:1 ratio to either surgical approach. The primary objective is to determine whether minimally invasive CABG improves functional recovery, assessed by the change in the physical component of the SF-36 Health Survey 30 days after surgery. Secondary outcomes include major adverse cardiovascular events, mortality, intensive care unit and hospital length of stay, duration of mechanical ventilation, return to usual activities, surgical site infection, perioperative complications, postoperative pain, readmission, and adherence to enhanced recovery measures. The results of this trial are expected to provide high-quality evidence regarding the optimal surgical approach for frail patients requiring coronary artery bypass grafting.

Post-induction hypotension (PIH) is a common and clinically significant hemodynamic complication following general anesthesia induction. Frail patients are particularly vulnerable due to impaired vascular reactivity and endothelial dysfunction. The Endothelial Activation and Stress Index (EASIX), calculated from routine laboratory parameters (LDH, creatinine, and platelet count), may serve as a preoperative biomarker to identify patients at risk for PIH. This prospective observational cohort study aims to evaluate the association between preoperative EASIX score and the occurrence of post-induction hypotension in frail patients undergoing elective non-cardiac surgery under general anesthesia. A total of 160 patients with a Clinical Frailty Scale (CFS) score of 4 or above will be enrolled. Mean arterial pressure will be measured every 2 minutes for the first 15 minutes after induction. PIH is defined as MAP below 65 mmHg and/or a decrease of 20% or more from baseline.

Sarcopenia prevention and management are highly prioritised goals in the Healthy Ageing agenda. The study aims to: 1) evaluate the effects of the digital-enhanced, volunteer-engaged collaborative care pathway to improve sarcopenia, reduce fall risk, and increase health-related quality of life (HRQL) among community-dwelling older adults with risk of, or diagnosed with, sarcopenia; 2) evaluate whether the volunteers who received health coach capacity training and supported the intervention experienced health benefits across time; 3) explore the engagement experiences and perceived effects of elderly participants with sarcopenia during the program; 4) evaluate the intervention implementation process and effects from the perspectives of social care workers.

Background With population ageing accelerating worldwide, long-term care needs are rising, and family caregivers have become an essential yet often under-recognised component of care systems. Older family caregivers are particularly susceptible to frailty because they shoulder substantial caregiving responsibilities while simultaneously experiencing their own age-related decline in health and physiological reserve. Frailty is a clinically important state of heightened vulnerability to stressors and is associated with serious adverse outcomes, including disability, hospitalisation, and mortality. In family caregivers, frailty may compromise not only health and quality of life, but also their capacity to sustain caregiving, with wider implications for the sustainability of family-based long-term care. Research gaps A scoping review conducted by this team indicated that middle-aged and older family caregivers, particularly spousal caregivers, are vulnerable to frailty, with caregiving-related, sociodemographic, physical, psychological, and social factors contributing to this condition. However, existing evidence remains fragmented. Caregiver-specific prognostic tools for estimating future frailty risk are lacking, and risk-stratified interventions among family caregivers are sparse. Aim This study aims to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers, identify modifiable risk factors, as well as develop and preliminarily evaluate a risk-stratified, social robot-assisted intervention to reduce the risk of frailty. Methods This study comprises four phases. Phase 1 is a completed scoping review that mapped evidence on frailty among middle-aged and older family caregivers. Phase 2 will use longitudinal data from the China Health and Retirement Longitudinal Study (CHARLS) to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers and to construct an online risk calculator. Phase 3 will develop social robot-assisted intervention based on the Capability, Opportunity, Motivation-Behavior (COM-B) model. Phase 4 will assess the feasibility, acceptability, and examine preliminary effects of the intervention. Expected outcomes This study is expected to provide a caregiver-specific tool for early frailty risk identification and risk stratification among middle-aged and older spousal caregivers. It will also generate a theoretically guided, risk-stratified social robot-assisted intervention targeting modifiable risk factors for frailty and provide evidence on its feasibility and acceptability, as well as preliminary effects. The findings will inform a future definitive large-scale trial and community-based caregiver support services.

The goal of this clinical trial is to determine whether a 6-month healthy-aging education program delivered in person, online, or in a hybrid format reduces frailty and is cost-effective compared with usual care in community-dwelling adults aged 65 years or older with pre-frailty or frailty. The main questions are: * Do the three educational programs, considered together, reduce the prespecified 40-item Frailty Index (40-FI) at 6 months more than usual care? * Are effects maintained 6 months after the programs end? * How do the in-person, online, and hybrid educational programs differ in multidomain frailty outcomes, implementation, costs, and quality-adjusted life-years? * Are changes in prespecified blood biomarkers and gut microbiota associated with changes in frailty and related outcomes? The study will enroll 276 participants. Randomization will occur at household level so that enrolled cohabitants receive the same assignment. Households will be allocated to in-person education, online education, hybrid education, or usual care. All three educational programs address physical activity, nutrition, cognitive and emotional well-being, and social connection. Assessments will occur at baseline, 6 months, and 12 months; blood and stool samples will be collected at baseline and 6 months. The trial will compare the average effect of the three active programs with usual care and will estimate modality-specific clinical and economic outcomes.

This randomized clinical trial investigates the effects of a home-based multicomponent exercise program (Vivifrail) on physical function, muscle morphology, and cognition in community-dwelling adults aged 90 years and older. Participants are randomized into three groups: Vivifrail at least twice a week, Vivifrail at least three times a week, or a control group. Outcomes are assessed at baseline, 12 weeks, and 24 weeks. The primary outcome is physical function measured by the Short Physical Performance Battery (SPPB).

The goal of this randomized controlled clinical trial is to evaluate whether the Ready for Safe Cancer Treatment (RESET) program improves perioperative care and supports safe hospital discharge in two surgical populations: adult patients undergoing planned oncological surgery and patients aged 70 years or older undergoing planned non-oncological surgery under general anesthesia. RESET is a comprehensive, multidisciplinary care pathway that combines prehabilitation, standardized perioperative care, enhanced recovery, and individualized transitional care after discharge. The main questions it aims to answer are: Does the RESET program reduce postoperative complications, prolonged hospitalizations, and unplanned rehospitalizations after oncological and non-oncological surgery? Does the RESET program improve patients' overall health status, physical function, quality of life, perioperative safety, and recovery? Does implementation of RESET improve the organization and efficiency of hospital care while reducing healthcare resource utilization and costs? Researchers will compare patients receiving the RESET program with patients receiving standard perioperative care to determine whether the comprehensive intervention leads to improved clinical, organizational, and patient-reported outcomes. Participants assigned to the RESET intervention will: undergo a comprehensive multidisciplinary prehabilitation assessment performed by a physician, physiotherapist, dietitian, psychologist, clinical pharmacist, nurse, and study coordinator; receive an individualized prehabilitation program that may include physical exercise, nutritional support, psychological support, medication optimization, and patient education before surgery; use a dedicated RESET mobile application to communicate with the multidisciplinary prehabilitation team, ask questions, receive individualized recommendations and information, follow the schedule of visits and planned activities, and support adherence to the intervention; undergo reassessment of their health status, needs, and implementation of recommendations on the day of hospital admission, allowing barriers to be identified and the perioperative care plan to be optimized; receive standardized in-hospital perioperative care incorporating Enhanced Recovery After Surgery principles, the SAFER Patient Flow Bundle, the Red2Green methodology, medication review by a clinical pharmacist, and coordinated multidisciplinary care; receive an individualized transitional care plan after discharge, including follow-up support and monitoring for complications and rehospitalization. Participants in the control group will receive standard perioperative care according to routine clinical practice at the participating hospitals. The study will evaluate clinical outcomes, including postoperative complications, prolonged hospitalization, rehospitalization, recovery, overall health status, physical function, and quality of life. It will also evaluate patient satisfaction, adherence to the RESET pathway, organizational effectiveness, and costs associated with implementation of RESET. The results are expected to support the development of an evidence-based and scalable perioperative care model that can be used in oncological surgery and in older patients undergoing major non-oncological surgery.

Frailty is an important geriatric syndrome associated with reduced physiological reserve, functional decline, falls, hospitalization, and increased health care use among older adults. This randomized controlled trial aims to evaluate the effect of a nurse-led telehealth-supported multicomponent frailty management program on frailty level and functional status in older adults living at home. The study will be conducted as a single-center, two-arm, parallel-group randomized controlled trial. A total of 100 older adults aged 65 years and older who are living at home and are frail or at risk of frailty will be randomly assigned to either the intervention group or the control group in a 1:1 ratio. Participants in the intervention group will receive an 6-week nurse-led telehealth-supported frailty management program, including weekly telephone counseling and individualized follow-up. Participants in the control group will continue usual care. Data will be collected at baseline, at 6 weeks, and at 18 weeks. The primary outcome is frailty level measured using the FRAIL Scale. Secondary outcomes include functional status, depressive symptoms, number of falls, emergency department visits, and hospitalizations.

The calf muscles (plantarflexors) are the most important muscles for walking, running and daily activities. Weakness of these muscles through aging and disease significantly impact a person's ability to walk and complete daily activities. By assessing calf strength, it is possible to identify people at risk of falls, and a condition called sarcopenia (which means loss of muscle mass, strength and function). Unfortunately, most of the studies that have examined this have used specialist equipment unavailable to hospital staff. Our study aims to use commercially available equipment to explore the relationship between plantarflexor muscle strength and physical performance in adults living with or without sarcopenia, including those at risk of it. The study will determine if stronger/weaker calf muscles associated with sarcopenia influence the ability to walk and do things more easily. We will complete strength tests of the calf, thigh and hand, assess walking using a special camera system, use an ultrasound scan to look at the Achilles tendon, use a scan to look at how stiff your calf muscles are, assess your body composition, complete a physical performance test and some questionnaires. Each participant will complete the measures during one clinic visit

Frailty is a significant risk factor for postoperative complications and functional decline. Preoperative assessment of frailty is therefore recommended in all older adults. However, despite the availability of many frailty tools, few have been tested in the preoperative setting and there is little comparison of their predictive value in identifying patients at risk. The aim of this study is to investigate which of the following instruments for determining frailty has the highest predictive power with regard to the occurrence of postoperative complications: Risk Analysis Index, Clinical Frailty Scale, the Groningen Frailty Indicator, the Edmonton Frail Scale and the LUCAS-FI. The aim of this research project is to identify a suitable frailty instrument for preoperative risk stratification of older patients during the premedication visit.

This study looks at how different pain-control methods affect how quickly older adults get out of bed and start moving again after major surgery. Researchers will observe patients aged 65 and older who are admitted to the intensive care unit (ICU) after major surgery. Doctors will use their usual pain-control methods - either medication given through a vein, an epidural, or a nerve block - based on standard clinical practice; the study team will not change or choose the treatment. The study will record how long it takes for each patient to first sit up, stand, or walk after surgery, along with pain levels, confusion (delirium), how satisfied patients are with their pain control, and how long they stay in the ICU. The goal is to better understand which pain-control approaches may help older patients recover and move more quickly and safely after major surgery.

Demographic aging is a growing global challenge, driven by increasing life expectancy and declining birth rates, with projections indicating that more than 30% of the European population will be over 65 years old by 2100. Centenarians represent a unique biological model of extreme longevity, often exhibiting delayed onset of age-related diseases and preserved functional capacity. This study aims to establish an intergenerational cohort of centenarians in Navarra (Spain) to investigate the biological, clinical, environmental, and lifestyle factors associated with extreme longevity. By integrating multidimensional data-including clinical assessments, functional and cognitive measures, and biological markers-this study seeks to improve understanding of aging mechanisms and identify potential determinants of healthy aging.

The purpose of this Phase I, open-label study is to evaluate the safety and tolerability of intravenous MiraMSC-FS-001 in older adults with mild to moderate frailty syndrome. MiraMSC-FS-001 is an investigational product consisting of allogeneic umbilical cord-derived mesenchymal stem cells (UCMSCs). Eligible participants will receive intravenous administration of MiraMSC-FS-001.

The objective of of this observational study is to evaluate the nutritional status and the prevalence of nutrition-related conditions, as well as dysphagia, among patients aged 65 years and older with mental disorders. The study will also identify key associated factors and inform the development of targeted strategies for the prevention, early identification, and management of malnutrition and related conditions. Furthermore, a draft clinical pathway for nutritional care will be developed, and its feasibility and effectiveness will be assessed.

Frailty and muscle health are important for patients with chronic liver disease. This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining muscle health in patients with liver disease. The investigators anticipate that this combination of supplementation and nutrition/exercise prehabilitation app will maintain muscle health in patients with liver disease.

Patients with advanced chronic kidney disease awaiting deceased-donor kidney transplantation frequently experience progressive functional decline, frailty, reduced mobility, and poor quality of life while on the transplant waiting list. Although multimodal prehabilitation programs based on exercise, nutritional optimization, and psychological support have shown promising benefits in major surgery, their implementation in kidney transplant candidates remains limited due to barriers related to accessibility, fatigue, transportation, and treatment burden. This randomized single-center clinical trial aims to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in patients awaiting deceased-donor kidney transplantation, comparing an in-person supervised model with a remote home-based model supported by a digital platform. The primary outcome will be the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcomes include physical activity level, frailty, nutritional status, kidney disease-specific quality of life (KDQOL-36), postoperative recovery quality (QoR-15), postoperative complications, and program adherence. The study seeks to generate clinically applicable evidence regarding the implementation and scalability of remote prehabilitation strategies in patients with advanced chronic kidney disease, with the potential to improve accessibility, sustainability, and perioperative outcomes in kidney transplantation.

This prospective observational study aims to evaluate the association between preoperative frailty and the procedural difficulty of ultrasound-guided internal jugular vein catheterization in adult patients undergoing elective cardiac surgery. Frailty will be assessed using the Clinical Frailty Scale and handgrip strength measurements. Preprocedural ultrasound evaluation will include internal jugular vein anatomical characteristics such as anteroposterior and transverse vein diameters, cross-sectional area (CSA), common carotid artery diameter, skin-to-vein distance, overlap status, and sternocleidomastoid muscle thickness Catheterization difficulty will be assessed using the Gaber Procedural Difficulty Index. The study seeks to determine whether frailty and ultrasound-derived anatomical parameters can predict difficult internal jugular venous catheterization and improve preprocedural risk assessment without altering routine clinical care.

This multicenter, prospective, non-interventional observational study (ORTOPODCZ) investigates the association between preoperative cognitive impairment and postoperative delirium (POD) in older adults undergoing elective total hip arthroplasty in the Czech Republic. Postoperative delirium is a frequent and serious neurocognitive complication in senior surgical patients and is associated with increased morbidity, mortality, prolonged hospitalization, and impaired functional and cognitive outcomes. Despite international recommendations, routine preoperative cognitive screening remains insufficiently implemented. The study evaluates the predictive value of the ALBA test, a brief cognitive screening tool, performed during the pre-anesthetic assessment. Postoperative delirium will be assessed using the validated CAM-ICU instrument for up to 72 hours after surgery. Secondary objectives include assessing the relationship between POD and frailty, polypharmacy, comorbidities, type of anesthesia, intraoperative hemodynamics, blood loss, vasoactive support, and postoperative complications. Approximately 300-400 participants aged ≥65 years will be enrolled across seven centers. No additional procedures, biological sampling, or deviations from standard clinical care are required. Data will be collected in REDCap and analyzed according to a predefined statistical analysis plan. The study aims to provide robust evidence supporting the integration of cognitive screening into routine preoperative evaluation and to describe feasibility and implementation requirements for the ALBA test in clinical practice.

The hypothesis is that the preoperative Clinical Frailty Score (CFS) is a predictive factor for a loss in quality-adjusted life years (QALYs) one year after emergency cardiac surgery under cardiopulmonary bypass (CPB) in patients aged 75 years and older.

A growing body of evidence suggests that patients who receive good perioperative care (i.e. care prior to surgery, during surgery, and after surgery) tend to have fewer complications, quicker recovery times, and shorter hospital stays. A key component of good perioperative care is recognizing individuals who have diminished physiological reserves (i.e. those who are vulnerable or frail). The stress of an invasive procedure can exhaust the diminished reserves of patients who are frail, which can in turn lead to perioperative complications, mortality and an increase burden to the healthcare system. Early interventions in patients with diminished reserves can be applied to reduce the risk of complications and poor outcomes. There are emerging studies that show promising benefits of perioperative interventions, such as prehabilitation, though with some mixed findings. Exercise has been shown to reverse or modify the molecular driving factors of frailty, which involve dysregulation of cytokine and endocrine pathways. Physical inactivity and prolonged sedentary behaviors are also emerging concerns in frailty because of the implicated deleterious health effects. Sedentary behaviors are associated with prevalence and severity of frailty. Among pre-frail and frail inactive adults, sedentary time is associated with higher mortality. Increasing physical activity is recommended as the most feasible approach to prevent and treat frailty. The aim of this study is to determine if a prehabilitation intervention that combines neuromuscular strength training and intervention to reduce sedentary behavior reduces complications, length of stay, and patient recovery, thereby also reducing the burden on the healthcare system.

Background. Decreased taste and smell contribute to loss of appetite (anorexia), and the resulting protein-energy malnutrition increases the frailty of the elderly. The risk of falls, disability, infections and depression often requires them to be institutionalized. Elderly, undernourished and toothless patients often complain about the monotony of a soft, mixed-texture diet. In a previous study, some participants highlighted the pleasure of crunching cookies that have a solid texture that can be eaten in any dental condition. However, the age-related decrease in hearing (presbyacusis) is frequent and progressive from the age of 60. The hypothesis of this work is that older patients may perceive a crunchy food crunching in their mouth, despite presbycusis. If the hypothesis is verified, this would make geriatric caregivers aware of the possibility of diversifying the texture of food, in order to stimulate the pleasure of eating and increase the dietary intake in this population of patients who are often undernourished, dysphagic, edentulous and hearing impaired. The originality of this study is to share the expertise of geriatricians and specialists in mastication/swallowing (dental surgeon, speech-language pathologist), hearing (ENT doctor, hearing care professional) and nutrition (dietician). Type of study. Type of study MR-004 "Research not involving the human person". Protocol. Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements: a soft filled cookie (Nutra Cake™, Délical, France) and a crunchy cookie of the Breton type (Protibis™, Solidages, France). Blind study impossible: each subject will eat a cookie then the other in a random order and will be his own control. The tests will be performed without the possible hearing aids, but with or without the dentures according to the patient's preference. Indeed, some patients have dental prostheses that are no longer suitable for chewing, and that they wear only for aesthetics. Objective. Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?" If so, encourage diversification with crunchy foods with a suitable texture, as well as dental and prosthetic rehabilitation of dependent elderly people.