Clinical Research Directory

The Effect of Walking on Frailty

The purpose of this study is to test the effect of walking intensity on both frailty category (i.e., frail, pre-frail, and nonfrail) and frailty score as a continuous outcome on the SHARE-FI (frailty instrument). As well as test the effect of walking intensity on mobility, physical function, balance, and total Physical Activity.

Strength Training in Hospitalized Patients Using the Ghostly App: a Feasibility Study

The goal of this feasibility study is to evaluate the use of the Ghostly app in rehabilitation of stroke patients, elderly and patients recovering from COVID-19 or ICU patients. In three randomized controlled trials, the effect of a strength training program incorporated in the Ghostly app will be assessed for 1) stroke patients suffering from weakness of the lower limb, 2) frail elderly with gait difficulties and 3) patients recovering from COVID-19 or ICU patients who suffer from muscle weakness. Additionally, the effect of BFR on strength gain in all these three populations will be tested.

Personalized Drug Treatment of Frail Patients: Integrated Care and Real-Time Home Monitoring

FRAIL-CARE is a prospective, multicentre, non-profit, low-intervention pilot feasibility study conducted in four Maugeri Scientific Clinical Institutes (IRCCS) in Lombardy, Italy. It will enrol 40 frail patients older than 65 years who take five or more drugs every day and are discharged home from cardiac, neurological or pulmonary rehabilitation, oncology or internal medicine units. After discharge, patients and their caregivers use a CE-marked digital health solution made of a smartphone app, a portable connected monitoring device and a clinician dashboard. Remote Specialist Operations Centres (COS), staffed by trained case managers, follow symptoms, vital signs and alerts and call patients at least once a week. The Poison Control Centre of Pavia acts as the emergency centre outside COS hours, for urgent clinical questions, drug interactions and treatment changes. In addition, blood concentrations of prescribed drugs that are not usually covered by therapeutic drug monitoring are measured at discharge, at 3 and 6 months, and whenever an adverse reaction, lack of efficacy or interaction is suspected. The main aim is to evaluate the impact of this integrated home care model on quality of life (EQ-5D-5L). Secondary aims are to assess usability and acceptability of the technology (System Usability Scale), adherence to therapy (MARS-5), early detection of critical clinical events and potentially toxic drug levels, and the number of dropouts. Each patient is followed for 6 months. The results will provide a basis for welfare policies supporting frail patients.

Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program

This prospective observational study will describe changes in physical function and fall risk among adults aged 70 years or older who participate in the routine Frailty and Falls Prevention Program at the Centro Integral de Saúde de Lalín. Clinical assessments obtained before the program (T0) and at its completion (T1, approximately 8-12 weeks later) will be analyzed. The study does not assign treatment or change routine care.

Body Composition, Frailty, and Function in Rehabilitation

The investigators are investigating if body composition measures - in particular muscle mass, body fat, and something called the phase angle - are able to reliably predict functional outcomes for patients who are in an acute hospital for inpatient rehabilitation. The investigators also want to see if age and frailty affect these relationships. Patients undergoing inpatient rehabilitation in our hospital will be monitored through a variety of frailty-specific tools, including strength and speed. The investigators will use a device called a body composition monitor (BCM) to record their body composition measurements. These will then be compared against their usual rehabilitation outcomes. The investigators believe that there is a correlation between these measures and a patient's functional outcomes.

Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease

Huntington's disease (HD) is a rare neurodegenerative disorder in which accelerated loss of muscle mass, strength and autonomy (physical frailty and sarcopenia) contributes to functional decline. This randomized, double-blind, placebo-controlled, four-arm parallel trial will include adults with HD and physical frailty/sarcopenia. All participants will follow a 12-week individualized, home-based multicomponent exercise program (VIVIFRAIL-based, with weekly remote monitoring) and will be randomized 1:1:1:1 to placebo, creatine (CRE), beta-hydroxy-beta-methylbutyrate (HMB) or combined CRE+HMB. The study will test whether combined CRE+HMB produces synergistic improvements in functional capacity, neuromuscular performance, body composition, cognition and quality of life, and will use multi-omic profiling (circulating and extracellular-vesicle microRNAs, plasma proteomics and genetics) to identify mechanisms and predictive signatures of response. Durability of effects will be assessed 6 months after the end of the intervention.

Selenium, Sarcopenia, and Frailty in Hemodialysis

Chronic kidney disease (CKD) is a significant public health issue with an increasing prevalence worldwide. In patients undergoing hemodialysis (HD) in particular, various factors-such as chronic inflammation, oxidative stress, nutritional disorders, and micronutrient deficiencies-can negatively affect muscle health and physical function. Selenium, an essential trace element with potent antioxidant properties, has been shown to be present at low levels in these patients and may be associated with muscle strength. Sarcopenia and frailty are critical clinical conditions in HD patients that diminish quality of life and increase the risk of hospitalization and mortality. This study aims to evaluate the relationship between serum selenium levels, sarcopenia, and frailty in patients undergoing chronic hemodialysis, and to investigate whether selenium levels might serve as a potential biomarker for these clinical conditions.

The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY

Canadian hospitals continue to struggle with severe emergency department and hospital bed capacity shortages. Maximizing bed availability and minimizing emergency department and urgent-centre visits by providing patients with alternative options to care is an important part of the solution. Surgical patients with frailty are at high risk of requiring subsequent acute-hospital care. The VICTORY trial will answer an important question that will inform how to improve care for surgical patients with frailty by determining the effect of virtual care with CloudDX technology compared to standard care to see if it can result in an increase in the number of days alive and at home that older people with frailty experience after planned surgery.

PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty

Fibroblast Growth Factor 19 (FGF-19) is an intestinal hormone secreted in the post-prandial state, whose primary role is to inhibit bile acid synthesis in the liver. It is expressed by the FXR (Farnesoid X receptor) nuclear receptor in the enterocytes of the ileum, which is activated by specific bile acids metabolized in the gut microbiota. It was demonstrated that treatment with FGF-19 induces myofiber hypertrophy in vitro and increases muscle strength and mass in mice model of sarcopenia. Sarcopenia and the commonly associated physical frailty, are age-related syndromes associated with adverse events (such as falls and fractures, mobility disability) and increased mortality. Currently, there is no drug treatment that has been proven effective to counteract those syndromes and standard care consists in non-pharmacological interventions (exercise and nutrition) whose implementation remains complex due to several barriers. Moreover, the anabolic resistance underlying sarcopenia hampers the exercise-induced response on muscle mass and the level of evidence for this outcome remains poor-to-moderate. Thus, FGF-19 could be considered as a new regulator of skeletal muscle in elderly living with sarcopenia/frailty but there are, to date, only few data available in the literature. First and foremost, it is crucial to understand the relationship between postprandial FGF-19 and muscle which has not been characterized yet. Preliminary data suggest an inverse relationship between FGF-19 and physical function (OR= 0.33 \[0.15;0.7\] for the highest tertile of FGF-19) that persisted only in the cluster of frail individuals (OR= 0.19 \[0.05;0.65\]. Mechanistically, this suggests a positive feedback loop of the bile acids-gut-microbiota-FGF-19 in the presence of frailty/sarcopenia hence indicating that FGF-19 may be a novel biomarker of this condition.

Frailty Training for Emergency Nurses: A Cluster RCT in Morocco

This study tests whether a training program helps nurses better recognize and care for older adults with frailty in hospital emergency departments. Frailty is a condition where older adults become more vulnerable to health problems. A small illness or injury can cause serious complications for a frail person. Emergency nurses often lack training to identify frailty quickly. In this study, some nurses will take part in a structured training program. The program includes four modules covering what frailty is, how to screen for it, and what nurses can do to help. Other nurses will not receive the training during the study. All nurses will complete a survey before, right after, and three months after the training. The study will take place in eight public hospital emergency departments in the Marrakech-Safi region of Morocco. A total of 144 nurses will take part. Researchers will measure whether nurses in the training group have better knowledge, attitudes, and practices about frailty compared to those who did not receive training. Researchers will also check whether the improvements last after three months. Hospitals are randomly assigned to either the training group or the comparison group. This is called a cluster randomized trial.

Strategies for Proactive Health in People With Kidney Function Decline

This prospective cohort study aims to investigate how kidney function decline affects multiple body systems and how personalized nutrition can help maintain health and slow disease progression. About 1,800 adults with reduced kidney function but not on dialysis will be followed over time at Huashan Hospital, Fudan University. The study will collect information on nutrition, heart and bone health, cognition, and daily functioning through hospital records and a patient mobile app. The goal is to understand the links between nutrition, metabolism, and organ function, and to develop integrated strategies for early prevention and management of chronic kidney disease.

Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)

The purpose of the study is to investigate whether an extended program (ERAS 3.0) initiated hospital discharge, can improve recovery in elderly, frail patients who have undergone surgery for colon cancer. The study is a randomised controlled trial with two groups: an intervention group receiving the ERAS 3.0 program and a control group recieving standard care. The ERAS 3.0 program includes a comprehensive geriatric health assessment, dietary counseling from a dietitian, and instructions on training and physical activity. These activities will take place in the participant's homes after hospital discharge. Data will be collected at multiple time points: at the hospital, 12 days post-discharge (at the outpatient clinic), and at 1 and 3 months post discharge in the participants' homes.

Hypoglycemia Risk Assessment in Elderly and Senile Female Patients With Type 2 Diabetes Mellitus

Hypoglycemia poses a particular danger for elderly patients with type 2 diabetes mellitus (T2DM). According to data, more than 30% of patients aged 60-69 years experience hypoglycemic episodes, and among persons over 85 years this figure exceeds 50%. The high risk is due to age-related changes: slowing of drug metabolism, decreased renal and hepatic function, weakening of counter-regulatory hormonal reactions, and impaired recognition of warning symptoms of severe hypoglycemia. The consequences of hypoglycemia in old age are especially severe, including increased risk of cardiovascular catastrophes, falls and fractures, and cognitive decline. This study aimed to identify predictors of hypoglycemia and assess its probability in elderly and senile women with T2DM for prevention in clinical practice.

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.

Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Aging Frailty

Sleep Quality and Frailty Among People Living With HIV

With effective antiretroviral therapy (ART), people living with HIV (PLWH) are living longer and are increasingly experiencing aging-related conditions such as frailty and sleep problems. However, most frailty research has focused on the general older population, and little is known about how sleep relates to physical and oral frailty in PLWH. This case-control study compares sleep disturbance, physical frailty, and oral hypofunction between adults living with HIV receiving ART and sex-matched HIV-negative pre-exposure prophylaxis (PrEP) users recruited from an infectious disease outpatient clinic at a medical center in southern Taiwan. The study also examines whether sleep disturbance (insomnia severity and daytime sleepiness) is associated with physical frailty and oral hypofunction, whether physical frailty represents an indirect pathway between sleep disturbance and oral hypofunction, and the roles of ART and serum Galectin-3 levels in predicting frailty among PLWH.

Exercise-based Frailty Intervention in Lung Transplantation (XFIT)

The goal of XFIT study is to measure the safety of an 8-week telehealth-delivered exercise and behavioral training program to treat frailty in lung transplant candidates in their own home. The main questions XFIT aims to answer are: * Is XFIT safe? * Is XFIT feasible and acceptable by participants? * Is XFIT effective in improving frailty and physical function as reflected in patient-reported outcomes. Participants will: \- Participate in the 8-week XFIT program or enhanced standard of care

Benefits of Strength Training in Informal Caregivers of Patients With Alzheimer's Disease

Informal caregivers of people with Alzheimer's disease experience high physical and psychological burden, increasing their risk of frailty, anxiety, and caregiver burnout. This randomized controlled trial aims to evaluate the effectiveness of a combined strength training and progressive muscle relaxation program compared with progressive muscle relaxation alone. The intervention will last 10 weeks, with assessments conducted at baseline, post-intervention, and at a 3-month follow-up. Primary outcomes include frailty, anxiety, and caregiver burden.

Longitudinal Geriatric Vulnerability, Chemotherapy Toxicity, and Functional Outcomes in Older Adults With Gastrointestinal Cancer

Older adults with gastrointestinal cancers may be more likely to experience side effects from chemotherapy and difficulties with everyday activities. These problems are not always explained by age alone. Changes in nutrition, physical strength, general health, and independence may also affect how well a person tolerates cancer treatment. The purpose of the VITAL-GI study is to better understand how health-related vulnerability in older adults is associated with chemotherapy side effects and changes in daily functioning over time. This is an observational study involving adults aged 65 years or older with gastrointestinal cancer that has not spread to distant parts of the body. Participants receive chemotherapy as part of their usual medical care, either before or after surgery, according to their treatment plan. The study does not assign chemotherapy treatments or change routine care. Researchers use questionnaires and clinical information to assess general health, nutrition, physical abilities, independence, and the risk of chemotherapy side effects. Assessments are performed when chemotherapy begins and approximately 3 and 6 months later. The study examines whether initial health assessments can help identify people who are more likely to experience serious chemotherapy side effects. It also examines how health, daily activities, symptoms, and quality of life change during treatment. The findings may help researchers better understand the supportive care needs of older adults receiving chemotherapy for gastrointestinal cancer.

Metformin for Preventing Frailty in High-risk Older Adults

Frailty is a geriatric syndrome which leads to poor health outcomes in older adults, such as falls, disability, hospitalization, institutionalization, and death. Due to the dramatic growth in the U.S. aging population and the health care costs associated with frailty (estimated at more than $18 billion per year), frailty is a major health care problem. There has been little research into potential pharmacologic interventions that would delay or reduce the incidence of frailty. Thus, the major goal of this study is to test metformin as a novel intervention for the prevention of frailty. The investigators propose that diabetes/insulin resistance and inflammation are major contributors to frailty, and that the use of metformin to modulate diabetes/insulin resistance and inflammation will prevent and/or ameliorate the progression of frailty.

Fall, Fracture and Frailty

This project aims to improve the global outcome for an aging individual after a traumatic fall, through identifying conditions contributing to a fall and promoting recovery and rehabilitation. Through better understanding 'falling phenotype', the ultimate aim is to prevent future complications, as well as new falls and fractures in the growing older population.

Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD

The goal of this observational study is to learn whether signs of immune aging and frailty can help predict the balance of benefits and risks of advanced therapies in adults aged 60 years or older with inflammatory bowel disease (IBD) who are starting a new advanced therapy. Treatment will be chosen by the participant's usual clinical team and will not be assigned by the study. The main questions it aims to answer are: Are baseline immune-aging and frailty characteristics associated with net clinical benefit at 52 weeks, defined as steroid-free clinical remission without serious infection, treatment discontinuation because of adverse events, IBD-related hospitalization, or IBD-related surgery? Can a low-cost combination of clinical and laboratory markers help identify older adults with IBD who are more likely to have favorable or unfavorable outcomes after starting advanced therapy? Participants will: Continue the advanced therapy selected as part of their usual clinical care. Complete study assessments of frailty, nutritional status, disease activity, and other health factors. Have routine and study-related blood tests, including measures related to immune aging such as CD4/CD8 ratio and interleukin-6 (IL-6). Be followed at approximately baseline, weeks 6, 14, 26, and 52, with longer-term safety follow-up planned to week 104 when feasible. Have information collected on remission, infections, hospitalizations, surgery, treatment continuation or change, and other health outcomes.

Community-Based Multicomponent Exercise and Recreational Programme for Older Adults

This quasi-experimental, non-randomized controlled evaluation examined whether participation in ELDERPLAY, a community-based programme combining Vivifrail-based multicomponent exercise with adapted traditional games, was associated with changes in physical performance and frailty-related function in community-dwelling adults aged 65 years and older, and estimated the cost of delivering the programme. Participants were allocated to the intervention group or to a concurrent control group through voluntary enrolment and geographic matching, without randomization. The intervention consisted of 20 supervised group sessions, two per week over ten weeks. Physical performance was assessed with the Short Physical Performance Battery and the Timed Up and Go test at baseline, at week 5 and at week 10. Secondary exploratory outcomes included actigraphy-derived daily step count, heart rate and sleep parameters, recorded over seven consecutive days at a single intermediate assessment point, and sleep quality assessed with the Pittsburgh Sleep Quality Index. Programme delivery costs were estimated from the perspective of the programme provider using an activity-based costing approach. Because allocation was not randomized and the groups differed at baseline, the findings are associative and do not support causal inference.

Biomarkers, Abdominal Muscle, and Frailty in CKD

In chronic kidney disease (CKD), inflammation and oxidative stress are important processes that may be associated with the development of muscle loss and frailty. The aim of this study is to investigate the relationships between serum MCP-1, total antioxidant status (TAS), and total oxidant status (TOS)-markers of inflammation and oxidative stress-and abdominal muscle thickness and frailty, as assessed by ultrasound, in stage 3-5 CKD patients not receiving dialysis. In addition, the study aims to assess participants' physical performance, kinesiophobia, and quality of life and to examine these characteristics according to CKD stages.