Clinical Research Directory

Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program

Frailty is common among older patients with chronic obstructive pulmonary disease (COPD) and is associated with poor functional outcomes and increased health risks. This study aims to determine the prevalence of frailty and to evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older COPD patients at Hospital 198, Ministry of Public Security, Vietnam.

Frailty Improvement Through Technology With Informal Caregiver Supported Exercise (FITWISE) for Pre-frail and Frail Community-dwelling Older Adults

The goal of this pilot trial is to evaluate the feasibility and potential effectiveness of a caregiver-mediated, technology-facilitated home-based intervention named Frailty Improvement through Technology With Informal Caregiver Supported Exercise (FITWISE) for pre-frail and frail community-dwelling older adults aged 60 years and older. Frailty is associated with reduced physical function, increased risk of falls, and higher healthcare utilization among older adults. Home-based interventions supported by informal caregivers and facilitated by digital technology may help improve exercise participation and health outcomes in this population. The main questions this study aims to answer are: 1. Whether the FITWISE intervention is feasible in terms of recruitment, participant engagement, adherence, retention, and safety. 2. Whether the FITWISE intervention improves physical performance and other health-related outcomes among pre-frail and frail community-dwelling older adults. Researchers will compare two intervention groups with a control group to determine whether the FITWISE intervention improves health outcomes. Participants will be randomly assigned to one of three groups: * Intervention Group A: Caregiver-mediated multi-component exercise supported by an exergaming system. * Intervention Group B: The same exercise program with additional caregiver-delivered psychosocial support. * Control Group: General health education and usual activities without the FITWISE intervention. The intervention will last 24 weeks and will include an active 12-week intervention phase followed by a 12-week maintenance phase. Outcome measures such as physical performance, frailty status, cognitive function, social support, quality of life, and selected health indicators will be assessed at baseline and after the 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.

Plant-based Diets and Healthy Aging

This prospective study investigates the health effects of vegetarian and plant-based diets in middle-aged and older adults in Taiwan, specifically, recruiting 5000 Tzu Chi volunteers. Previous Tzu Chi cohorts found vegetarian diets were protectively associated with incidences of diabetes, stroke, gout, cataracts, insomnia, and gallstones, while reducing healthcare costs. The study also aims to clarify dietary patterns-particularly plant-based and vegetarian diets-and determine how potential deficiencies or excesses of various nutrients influence common aging-related health issues, including healthy cognitive decline, sarcopenia, and the risk of age-related diseases, in order to inform dietary and lifestyle recommendations that promote healthy aging and maintain physical function.

Strength-based Tailored-Exercise Program at Home for Geriatric Patients

This study focuses on the "Strength-based Tailored-Exercise Program at Home (STEP@Home)" aimed at improving health outcomes for geriatric patients at risk of hospitalization-associated functional decline. It is a sequential mixed-method study that combines quantitative and qualitative approaches.

The Relationship Between Preoperative Frailty and Postoperative AKI and the Mediating Effect of Intraoperative BP

The primary objectives of study is to compare the difference in the incidence of postoperative AKI between frail and non-frail patients. The secondary objectives of study was to compare the differences in intraoperative blood pressure fluctuations, the incidence and duration of intraoperative hypotension, postoperative extubation time, postoperative complications, length of hospital stay and hospitalization expenses between frail and non-frail patients, and use mediating effect analysis to examine the magnitude of the effect of intraoperative blood pressure on postoperative acute kidney injury caused by frailty.

Frailty and Nottingham Hip Fracture Score for Predicting 90-Day Mortality After Hip Fracture Surgery

Hip fractures are serious injuries that occur mostly in older adults. Many people experience health problems or may die in the months after surgery. Doctors try to identify patients who have a higher risk of poor outcomes as early as possible. Doctors often use the Nottingham Hip Fracture Score (NHFS) to estimate the risk of death after hip fracture surgery. This score uses information such as age and other health conditions. However, it does not fully reflect how physically vulnerable a person may be. Another important concept is frailty. Frailty describes how strong or weak a person's overall health and physical reserve are. In this study, frailty will be measured using the Clinical Frailty Scale (CFS). This scale evaluates a person's level of independence and physical function before the fracture. The purpose of this study is to determine whether measuring frailty can improve the prediction of death after hip fracture surgery. Older adults with hip fractures who undergo surgery will be invited to participate in the study. Researchers plan to include about 200 participants or all eligible patients enrolled within one year, whichever occurs first. Health information that is already collected during routine hospital care will be recorded. Frailty will be assessed when participants are admitted to the hospital. Participants will be followed for 30 days and 90 days after surgery to determine survival status. Researchers will review hospital records and may contact participants or their relatives by phone if needed. The results of this study may help doctors better identify patients at higher risk and improve care planning after hip fracture surgery.

Tele-Rehabilitation in Adults With Cystic Fibrosis

This study is a randomized controlled trial designed to evaluate the effectiveness of an 8-week tele-rehabilitation program in adults with cystic fibrosis. Cystic fibrosis is a chronic condition that affects the lungs and can lead to reduced muscle mass, physical weakness, frailty, and decreased quality of life. Participants will be randomly assigned to either a tele-rehabilitation group or a usual care group. The tele-rehabilitation program includes supervised exercise sessions conducted remotely three times per week using video communication. The program combines aerobic and resistance training based on established rehabilitation guidelines. The primary aim of the study is to assess the effect of the program

Healthy Ageing: a Feasibility Study to Evaluate Digitally-enabled Ways to Support Healthy Ageing

The goal of this clinical trial is to learn if it is feasibility to conduct a trial of two digitally-enabled interventions that support older adults to adopt healthy behaviours. It will also learn about the safety of this digital intervention. The main questions it aims to answer are * How acceptable and feasible are the trial, intervention and control groups in assessing outcomes * What is the estimated effect of the interventions? Researchers will compare Smart devices with a bespoke 'Healthy Habits' application and three healthy habit coaching and data feedback modules, to a group with smart devices and standard off-the-shelf feedback application, to a control group that will receive an education leaflet to adopt healthy behaviours. Participants will: * Use sensors and the 'Healthy Habits' application for 3 months followed by standard application for 3 months, or sensors and standard application for 6 months, or control * Either home visit or in-centre visit once every 3 months for assessments and online health questionnaires * Complete daily diary of any healthcare use

Telehealth-Supported Discharge Programme for Frail Older Adults

This pilot clinical trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a telehealth-supported discharge programme on physical and mental health outcomes, and healthcare utilization among community-dwelling older adults with frailty after hospital discharge. The objectives are: 1. To determine the feasibility and acceptability of the programme by assessing participant recruitment, retention, adherence rates, and satisfaction; 2. To evaluate the preliminary effects of the programme on a) physical health outcomes (e.g., physical fitness, activities of daily living), b) mental health outcomes (e.g., depressive symptoms, perceived social support, quality of life, subjective well-being), and c) healthcare utilization (e.g., emergency department visits, hospital readmissions); and 3. To identify perceived barriers and facilitators of the programme and evaluate the acceptability and usability of gerontechnology activity sensors and pedometers for monitoring activity levels. Community-dwelling older adults 65 years with frailty (N=50) will be recruited through a local hospital. Participants will be randomized to either the intervention or control group. The 12-week telehealth discharge support programme consists of weekly reablement-focused sessions integrating gerontechnology activity sensors and pedometers to enhance physical and mental health outcomes. Both groups will continue to receive usual care. Descriptive statistics will be used to summarize participant data. Effect sizes will be calculated to estimate the effects of the intervention on the outcomes. Qualitative data will be analyzed using thematic analysis.

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.

Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.

To assess the prevalence and severity of frailty in patients undergoing LAAC, as well as its association to peri-procedural and long-term outcomes and quality of life.

G8 Screening Tool Validation in Older Adults With Cancer in Portugal

The G8 screening tool is widely recommended for the identification of frailty in older adults with cancer. However, prospective validation data in the Portuguese population are currently lacking. This prospective observational study aims to evaluate the diagnostic performance of the G8 screening tool compared with a Comprehensive Geriatric Assessment (CGA) in older adults with cancer. Patients aged ≥70 years with solid tumors will be assessed using both the G8 screening tool and a multidimensional CGA. Frailty will be defined as impairment in at least one CGA domain. The performance of the G8 will be evaluated in terms of sensitivity, specificity, and area under the receiver operating characteristic curve. This study aims to provide the first prospective validation of the G8 screening tool in Portuguese older adults with cancer and to support its implementation in clinical practice.

Risk-Based Geriatric Assessment-Driven Management in Older Patients Starting Chemotherapy

Older patients with cancer are at increased risk of severe chemotherapy-related toxicities due to comorbidities, functional impairments, and geriatric syndromes. Comprehensive geriatric assessment (GA) can identify vulnerabilities and guide tailored management, but routine implementation is challenging due to time and resource constraints. This pilot randomized controlled trial evaluates the feasibility and preliminary efficacy of a patient self-report, risk-based geriatric assessment-driven management algorithm (GA-MA) compared with usual care in older patients starting chemotherapy. Participants aged 65 years or older who are initiating a new chemotherapy regimen are randomized in a 1:1 ratio to receive either GA-MA plus usual care or usual care alone. The primary outcome is the incidence of grade 3 or higher chemotherapy-related toxicities within three months of treatment initiation. Secondary outcomes include emergency department visits, unplanned hospitalizations, early chemotherapy termination, and changes in frailty and performance status. Feasibility outcomes include recruitment, retention, adherence to GA-driven recommendations, and time required to complete geriatric assessment.

Prehabilitation in Gynaecological Cancer Patients

Prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. These interventions usually consist of physical activity and psychological and nutritional support. There is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients. PHOCUS trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. Sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into ARM A: control arm which will be provided with a basic information and standard of care support; ARM B: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. All patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.

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.

AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease

The goal of this three-year mixed-methods observational study with an embedded randomized controlled trial is to develop and validate a frailty risk prediction model and evaluate an artificial intelligence-based voice emotion detection-guided counselling intervention in adults with congenital heart disease (ACHD). The main questions it aims to answer are: Are symptom clusters associated with frailty and psychological outcomes in adults with congenital heart disease? Can symptom clusters and psychosocial factors be used to predict frailty risk over time in ACHD patients? Does an AI-based voice emotion detection-guided counselling intervention improve psychological outcomes, fatigue, and quality of life among high-risk ACHD patients? Researchers will compare ACHD patients receiving AI-based voice emotion detection-guided counselling with those receiving usual care to determine whether the intervention reduces depression, anxiety, sleep disturbance, fatigue, and frailty risk, and improves grit and quality of life. Participants will: Complete longitudinal assessments of symptom clusters, frailty, and psychological status at baseline and follow-up time points Participate in qualitative interviews to explore lived experiences related to symptoms and frailty Receive AI-based voice emotion detection-guided counselling (intervention group only in Year 3)

PAtient-centered mUltidiSciplinary Care for vEterans Undergoing Surgery (PAUSE)

The PAUSE Trial is a pragmatic, randomized clinical trial for Veterans scheduled for elective surgery at 3 large VA facilities (Palo Alto, Houston, and Nashville). The PAUSE Trial focuses on cooperation between providers of various disciplines in order to provide better care. Veterans identified as frail upon standardized will be referred to a multidisciplinary "PAUSE Board" comprised of members from surgery, anesthesia, geriatrics, palliative care, case management, rehabilitation, and nutrition. Diverse specialists will come together in a team environment to discuss care options, scientific evidence, and patient goals and expectations, creating individual patient recommendations. The investigators hypothesize that the PAUSE Board model will improve quality and outcomes by promoting guidelines and evidence-based care recommendations as well as constructive team-based discussions to align care with patient goals and expectations.

Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit

Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit

MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care

The goal of this clinical trial is to learn whether a structured, Patient-Reported Outcome Measures (PROMs)-tailored palliative care pathway improves clinical outcomes and care experience in adults with advanced cancer referred to outpatient palliative care. Patients with advanced cancer often experience multiple symptoms and complex needs. Standard outpatient palliative care is usually guided by clinical judgment on patient-reported questionnaires. In this study, researchers aim to test whether a more structured approach, based on predefined cut-offs from PROMs, can improve symptom control, satisfaction with care, and use of healthcare resources. The main questions the study aims to answer are: Does a structured, PROM-driven palliative care pathway reduce symptom burden and psychological distress compared with usual care? And through this, to improve patients' and caregivers' satisfaction with care or reduce emergency room visits, hospital admissions, healthcare costs, and aggressive treatments near the end of life? Researchers will compare two groups: Control group: Participants will receive standard outpatient palliative care. PROMs are collected as usual, but without predefined cut-offs or structured intervention checklists. Experimental group: Participants will receive a structured palliative care pathway tailored to symptoms/needs identified at baseline using PROM cut-offs. Specific multidisciplinary interventions are activated according to identified needs.

Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.

The hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected. Furthermore, based on previous assessments, it is anticipated that there will be an improvement in volume status (reduced edema), symptom burden, and physical capacity in patients. Additionally, the study will assess the impact of the intervention on functional parameters such as motor capacity, physical activity, performance of activities of daily living, and ultimately, participation and quality of life.

Preoperative Oral Nutrition And Outcomes In Frail Elderly Patients With Femur Fractures

The goal of this observational study is to learn whether preoperative oral nutrition support improves clinical outcomes in elderly patients with femur fractures who have a high frailty index. The main questions it aims to answer are: * Does preoperative nutrition support improve hemodynamic stability during and after surgery? * Does it reduce postoperative complications, mortality, and length of hospital stay? Researchers will compare patients who receive preoperative oral nutrition support with those who follow routine nutrition. Participants will: * Receive routine medical care with or without nutrition support * Have their hemodynamic values, complications, and outcomes recorded during hospitalization * Be followed at 30 and 90 days after surgery for complications and mortality.

Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension

The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability.

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.