Clinical Research Directory

Nurse-Led Telehealth Frailty Management in Older Adults

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.

Tai Chi and Laughing Therapy for Improving Functions of Frail Older Adults

The goals of this study are to examine the physical function, cognitive function, and quality of life among frail elderly residing in the community

Comparison of Preoperative Frailty Assessment Tools

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.

Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure

In a randomized controlled trial, to study the utility of inspiratory muscle training (IMT) to improve functional outcomes in adults aged ≥70 years with heart failure (HF) who have been referred to palliative care for end-stage HF management. * The study team hypothesize that older HF patients will be able to use IMT safely, reliably, and effectively in a 12-week home-based training regimen. * The study team hypothesize that physical function (sit to stand, gait speed, grip strength), respiratory/pulmonary function, self-efficacy, fatigue and quality of life will increase among older HF patients randomized IMT versus those randomized to usual care.

Improving Physical Ability and Cellular Senescence Elimination in HIV

This clinical trial is a Phase II study designed to test the safety and effectiveness of a combination of dasatinib and quercetin (D+Q) in improving physical function for people with HIV who are frail or prefrail. The study will involve 80 participants, all aged 50 or older, who have been living with HIV for at least 10 years determined to meet criteria for diagnosis of frail or prefrail and are currently on a stable antiretroviral therapy with viral suppression. Participants will be randomly assigned to one of two groups: one group will receive the D+Q treatment, and the other will receive a placebo. The treatment will be given in six cycles over 12 weeks, with participants taking the medication for two days followed by 12 days without treatment. After the 12-week treatment period, participants will be monitored for another 12 weeks to assess the long-term effects. The study aims to determine if D+Q can improve physical function and other health outcomes in this population. Randomization will be stratified by sex and age to ensure balanced groups.

Prehab and Creatine/Whey Supplementation in Frailty Among Patients With Cirrhosis

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.

Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients

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.

Frailty is a Risk Factor Postcholecystectomy

The goal of this observational study is to learn about the long-term effects of cholecystectomy in patients over the age of 60 who take cholecystectomy to treat their acute cholecystitis). The main question it aims to answer is: Does frailty a risk factor for postcholecystectomy complications?

WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program

This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology. There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one. The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can: * be delivered without any associated serious cardiac events; * will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline. * will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline. * will result in increased step counts measured monthly from baseline to end of intervention * will improve self-reported quality of life from baseline to post-intervention. * will result in increased patient reported activity level from baseline to post-intervention

Home Exercise And Resiliency Training (Heart) Club

The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.

Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic

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.

CALLY Index, Frailty and SOFA-2 for Mortality Prediction in Geriatric ICU Patients

This study aims to evaluate the prognostic value of the C-reactive protein-albumin-lymphocyte (CALLY) index, Clinical Frailty Scale (CFS), and SOFA-2 score in predicting mortality among geriatric intensive care unit (ICU) patients. The primary outcome is ICU mortality. Secondary outcomes include 28-day mortality, ICU length of stay, duration of mechanical ventilation, need for renal replacement therapy, and vasopressor requirement. The study also investigates whether the combined use of these parameters improves predictive performance compared to conventional scoring systems such as APACHE II.

EASIX Score and Post-Induction Hypotension in Frail Patients Undergoing Non-Cardiac Surgery

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.

Feasibility of a Multidisciplinary Student-Led Program to Improve Frailty in Nursing Home Residents

BACKGROUND Frailty, regarded as a potentially reversible process and defined as a progressive deterioration of physiological systems and intrinsic capacity, constitutes a key risk factor for disability, dependency and institutionalisation. Currently, it is estimated that between 50% and 75% of older adults living in residential care facilities present with frailty. This clinical profile is often directly associated with multiple comorbidities (around 65-85% of this population suffer from several chronic conditions), emotional decline, polypharmacy, malnutrition and a high prevalence of functional and cognitive impairment. Consequently, two out of every three older adults will require long-term care in specialised centres during their lifetime. In this context, nursing homes represent a key setting not only for providing care, but also for the prevention, detection and management of conditions such as frailty. However, care in residential facilities continues to focus on addressing established problems, with low participation in activities with potential benefits and a high perception of loneliness. Therefore, interventions in these contexts aimed at improving frailty are both necessary and urgent, particularly those that integrate a biopsychosocial approach, promote autonomy and foster active ageing. Several studies have demonstrated that multidisciplinary intervention programmes and multicomponent physical training are effective in preventing frailty and its consequences. Nevertheless, their widespread implementation is limited by several factors. On the one hand, there is a lack of scientific evidence on the cost-effectiveness of such interventions, and on the other, healthcare systems face budgetary constraints in a context of increasing demand for geriatric care. In the search for more effective interventions to improve frailty and other related variables in older adults residing in nursing homes, supervised multidisciplinary programmes, delivered by health sciences students and implemented by nursing students, may represent a viable alternative. In this regard, students of Physical Activity and Sport Sciences (CAFYD) possess the knowledge required to design physical activity plans adapted to the capacities and needs of older adults. However, given the nature of their care role, nurses provide added value: their continuous presence in the clinical setting enables them to establish a closer therapeutic bond with the patient, ensure thorough monitoring of their progress, and facilitate coordination between physicians and other healthcare team members. These features make nurses key agents in the implementation of comprehensive, person-centred interventions. Despite the potential of implementing a multidisciplinary intervention programme through health sciences students to improve frailty in older adults living in residential facilities, to the best of our knowledge, no similar interventions exist. Therefore, it is necessary to assess the feasibility of implementing such a proposal prior to conducting a randomised controlled trial to confirm its clinical effectiveness, as this approach plays an important role in determining the most appropriate trial design. To this end, different feasibility study guidelines recommend including variables such as acceptance, adherence and dropout rates as key markers for successful implementation. STUDY'S HYPOTHESIS The main hypothesis of the CUIDAFRAIL project is that a supervised multidisciplinary intervention programme carried out by nursing and Physical Activity and Sport Sciences students is feasible for improving frailty and other related variables in older adults living in residential care facilities. AIM AND OBJECTIVES The aim of the CUIDAFRAIL project is to examine the short- term and medium-term effects of a nursing students' multidisciplinary intervention programme on frailty among older adults living in nursing homes. The secondary objectives of this project are the following: 1. To examine the effects of the intervention on frailty, as well as other frailty-related variables, including physical fitness, functionality, fear of falling, emotional status, loneliness, social support and quality of life in older adults living in residential care facilities. 2. To examine the effects on physiological and clinical parameters associated with frailty. 3. To explore the perceptions and experiences of older adults participating in the programme upon completion. 4. To explore the perceptions and experiences of nursing and Physical Activity and Sport Sciences students upon completion of the programme. STUDY DESIGN A feasibility study will be carried out. Participants will be randomly assigned to either an intervention group (IG) or a control group (CG).

SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older

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.

Reducing Frailty for Older Cancer Survivors Using Supplements II

This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.

Health Ahead Comparative Effectiveness Study

The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening - each isolated as a single variable against current practice - on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, allowing results to accumulate on a consistent yardstick across the life of the platform. The first comparison evaluates static versus interactive personalized health report delivery. Subsequent pre-planned comparisons, added by protocol amendment, evaluate mobile community versus fixed laboratory screening; and a hybrid medical-droid plus human-delivery model versus human-only screening. All participants are simultaneously enrolled in the 100-Year Human Aging Study and the Human Observatory Study, contributing individual longitudinal and population-level causal inference data through those protocols.

P-POSSUM for Outcomes After Abdominal Surgery

Postoperative complications after abdominal surgery can lead to prolonged recovery, intensive care admission, and death. The P-POSSUM score is a commonly used surgical risk prediction tool, but its performance may vary between hospitals and patient populations. Frailty, especially in older patients, may also affect postoperative outcomes and may improve risk prediction when added to existing scoring systems. This ambispective observational cohort study evaluates the prognostic value of the P-POSSUM score, with additional assessment of frailty and routine perioperative clinical data, for predicting postoperative complications and treatment outcomes in adult patients undergoing abdominal surgery at Bach Mai Hospital. The study includes retrospective data from January 2025 and prospective data collection through May 2026. No intervention is assigned by the investigators. All patients receive routine perioperative care according to clinical practice. The study will assess the predictive performance of P-POSSUM for postoperative complications and mortality, and will explore whether adding frailty-related variables improves risk prediction.

Evaluation of a Health Monitoring Platform for Elderly in Home Care Context

This study aims at, as a primary objective, studying acceptability of elderly about a health monitoring platform for home support and home care. The secondary objective consists in studying the correlation of different health data evolution and the frailty trajectory of the subject.

Remote Exercise Video Adaptations to Maximize Physical Activity in Childhood Cancer

The goal of this observational study is to leverage childhood cancer survivor input to adapt video content of a digital video disc-(DVD) delivered evidence-based PA intervention, originally designed for community-dwelling older adults. Primary Objective: \- To leverage childhood cancer survivor input to adapt video content for an evidence-based remote exercise intervention.

The SHAPE Project (Hospital System for Physical Activity and Active Participation) After Hospitalized Decompensation of Respiratory Chronic Diseases

It is widely established that a lack of adapted physical activity (APA) and sedentary behaviors increase the prevalence of frailty, which exacerbates chronic diseases. Hospital stays amplify this phenomenon, leading to physical deconditioning, often irreparable, especially in older patients if it is not detected and treated promptly. To date, there is no standard of care focused on APA to address frailty acquired during hospital stays. In this context, the SHAPE project (Hospital System for Physical Activity and Active Participation) aims to prevent dependency in older adults with chronic diseases by developing an innovative patient journey based on APA. The project seeks to reduce frailty acquired during hospital stays by establishing standards for APA prescription, based on early diagnosis and intervention. SHAPE ensures equal access to care through an accessible and user-friendly web platform, designed for older users and also including those in rural areas. It fosters the resilience of healthcare systems by integrating a preventive and multidisciplinary approach into hospital treatments and optimizes resources through a tiered care model that provides progressive and personalized care. Although hospital stays have been shown to trigger physical deconditioning, there is no adapted physical activity program initiated by the hospital and followed at home after hospital discharge from a severe exacerbation in patients with chronic respiratory diseases. The SHAPE Project offers a highly beneficial tool for patients with acute or exacerbated chronic respiratory disease requiring hospitalization, promoting better overall recovery after discharge. Furthermore, this project will foster healthy lifestyles and promote health from a sustainability and prevention perspective. Of particular interest is the opportunity to offer a lifestyle change program (physical activity and hygiene-dietary measures) focused on respiratory patients and adapted to their specific needs. Moreover, the project is considered innovative in implementing healthy clinical practices through telemedicine. In addition, it offers post-hospital discharge services that, to date, have not been considered in a generic way for respiratory patients except in selective subgroups (post-COVID, patients included in lung transplant program, etc.). In respiratory patients who have required high-risk admission due to decompensation, the implementation of the SHAPE program after hospital discharge as a support program that combines an adapted physical activity plan and general hygiene and dietary advice will improve the health indicators (frailty, sarcopenia, dyspnea, exercise tolerance, quality of life) of these patients.

Resistance-Based Multicomponent Training Plus Nutrition Supplementation for Intrinsic Capacity and Disability Risk in Chinese Rural Older Adults

This study is a five-arm, parallel-group, assessor-blinded randomized controlled trial designed to evaluate the effects of resistance-dominant multicomponent training combined with nutritional supplementation on intrinsic capacity and disability risk among rural Chinese older adults. A total of 220 participants aged 60 years or older with mobility decline, nutritional risk, sarcopenia risk, or pre-frailty/frailty will be randomly assigned to one of five groups: control, nutrition supplementation alone, resistance training alone, resistance training plus nutrition supplementation, or resistance-dominant multicomponent training plus nutrition supplementation. The intervention will last 12 weeks. Exercise interventions will be conducted three times per week, and nutritional supplementation will include leucine-enriched whey protein and vitamin D. The primary outcomes are the Short Physical Performance Battery score, FRAIL score, and activities of daily living/instrumental activities of daily living scores. Secondary outcomes include gait speed, Timed Up and Go test, sit-to-stand performance, handgrip strength, nutritional status, protein intake, serum 25-hydroxyvitamin D, calf circumference, and appendicular skeletal muscle mass index.

A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings

Maintaining functional status, or the ability to perform daily activities, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into patient care has been slow and inconsistent due to the burden posed by current tools. The purpose of the proposed QUERI Partnered Evaluation Initiative is to implement and evaluate a patient-centered, low-burden intervention to improve measurement of functional status in VA primary care settings nationally. The investigators hypothesize that implementing this intervention will increase identification and improve management of functional impairment among older Veterans while providing key data to inform VHA strategic planning related to long-term services and supports.

Frailty and Severity as Determinants of Hospital Cost in the ICU

This study evaluated the association between baseline frailty (mFI-11) and acute illness severity (SAPS 3) with real hospital costs in adult patients admitted to the Intensive Care Unit (ICU). The objective was to determine if frailty and severity are independent predictors of resource consumption.