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NCT07570628
This observational study aims to evaluate the real-life use of a digital tool (Fragiclic) by general practitioners (GPs) and nurses to screen and assess frailty in adults aged 65 and over. Frailty is a syndrome that increases the risk of loss of autonomy, falls, hospitalizations, or death. The tool includes simple screening questionnaires (such as SEGAm) and a comprehensive assessment (CGA - Comprehensive Geriatric Assessment) to better manage patients' health. The main question it aims to answer is: * What proportion of patients aged 65 and over will benefit from frailty screening or assessment using Fragiclic over 12 months? A secondary question is \- Does the use of Fragiclic reduce the risk of unplanned hospitalizations or death in these patients? For the secondary question, researchers will compare patients who received screening or assessment (with or without a Personalized Care Plan (PCP)) to those who did not, to determine if Fragiclic improves their health outcomes. Participants will not have additional tasks: Their GP or nurse will use Fragiclic during routine consultations. Some patients may be asked to provide information about their health or quality of life (via their healthcare provider). All data will be collected anonymously and securely
NCT04733534
This is a first-in survivor pilot study with the goal of establishing preliminary evidence of efficacy, safety, and tolerability of two senolytic regimens to reduce markers of cellular senescence (primary outcome: p16\^INK4a) and improve frailty (primary outcome: walking speed) in adult survivors of childhood cancer. If successful, this pilot would provide the preliminary evidence needed for a phase 2, randomized, placebo-controlled trial to establish efficacy. Primary Objective * The primary aim of this proposal is to test the efficacy of two, short duration senolytic regimens: 1) combination of Dasatinib plus Quercetin and 2) Fisetin alone, to improve walking speed and decrease senescent cell abundance in blood (p16\^INKA): * Primary endpoints of this trial will be change in walking speed and senescent cell abundance in blood (p16\^INK4A) determined at baseline and again at 60 days, within an individual arm. Extended follow up at 150 days will assess the permanence of change after completion of the trial. Secondary endpoints of this trial will be effect of intervention on additional measures of frailty (beyond walking speed; Fried criteria) and on other cell senescence markers, markers of inflammation, insulin resistance, bone resorption, and cognitive function. Secondary Objectives The secondary aim is to test the safety and tolerability of two different senolytic therapies. Exploratory Objectives * To compare the efficacy of the two senolytic regimens in improving walking speed and decreasing senescent cell abundance * To evaluate the longitudinal pattern in measures of frailty.
NCT07465159
Background: Frailty is a geriatric syndrome of reduced physiologic reserve that increases surgical risk and is common among older adults undergoing hip or knee replacement. While prehabilitation has shown promise in enhancing outcomes, evidence from randomized controlled trials (RCTs) in frail orthopedic patients is limited. Objective: This study aims to evaluate the feasibility and preliminary data on the effectiveness of a multimodal prehabilitation program for frail patients undergoing elective hip or knee arthroplasty. Methods: A pilot RCT will be conducted at Landspítali-University Hospital. Patients ≥70 years scheduled for surgery with ≥2 months waiting time will be screened for frailty using PRISMA-7, the Clock Drawing Test, and Timed Up \& Go. Patients screening positive for any of the three screening tools will be randomized to multimodal prehabilitation or standard of care. The intervention includes comprehensive geriatric assessment, medication review, tailored physiotherapy using the Otago Exercise Programme, and nutritional counseling if at risk of malnutrition. We will conduct an external pilot for feasibility measures (overall enrollment, recruitment, retention, adherence). Secondary outcomes include physical performance, postoperative complications, patient-reported health status (WOMAC scale) and quality of life (EQ-5D-5L ), length of primary hospital stay, discharge location, falls postoperatively, 180-day readmission and 180-day mortality. Significance: This trial may aid in the design of larger RCT study and provide a signal of the role of multimodal prehabilitation on outcomes, including quality of life and health status among frail arthroplasty patients.
NCT04764617
As people get older, the amount of skeletal muscle in the body can decrease. When the amount of this muscle in the body gets very low, there is an increased risk of falling, and not only is recovery to any injury slower, but more complications can be experienced following surgery, and patients may end up being more dependent on the help of others for meeting daily activities. However, it is not clear whether it is simply the amount of muscle that is in the body that is important for health, or whether it is the ability of muscle to function properly which is important. This research study is looking at the way muscles of frail older people function; not just how strong they are, but the amount of fats and protein that there are in muscle cells, and how the genes in the muscles are being expressed (genes being a collection of chemical information that carry the instructions for making the proteins a cell will need to function). We will also investigate whether recovery from hip fracture is impacted by the amount of muscle that there is in the body, and/or the functioning of this muscle.
NCT07504419
This international multicenter study project. A physical function screening activity for the elderly will be held in the community centers. After screening out high-risk subjects for frailty, they will be guided to participate in motivational interviews. Design thinking is used to design product/service processes based on nutritional problems, and combined with the nutritional care process.
NCT06925880
Double-blind randomized placebo-controlled clinical trial with two parallel arms. The main objective is to evaluate the efficacy and safety of creatine supplementation in older adults who have been operated on for total knee arthroplasty and undergoing a usual rehabilitation program. The intervention will consist of daily creatine monohydrate supplementation for 12 weeks. The intervention will start after surgery with a loading dose of 20g/day for 1 week and then continue with a maintenance dose of 5g/day for 11 weeks. Main outcome mesures included muscle mass, muscle strenght, sarcopenia, frailty, functional capacity and physical performance and will be assessed at baseline, 3 and 6 months follow-up.
NCT06280586
Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them. The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty. These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want. In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in.
NCT05257954
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.
NCT07485634
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.
NCT07479654
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)
NCT07481188
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.
NCT05037292
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.
NCT07469761
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.
NCT07191613
The goal of this quasi-experimental clinical trial is to evaluate the effects of the "HAPPY GO GO" somatosensory game on physical and mental health in community-dwelling older adults aged 65 years and above living in rural Chiayi County, Taiwan. The main questions it aims to answer are: * Does participation in the somatosensory game improve physical health outcomes (e.g., balance, mobility, functional fitness)? * Does participation improve mental health outcomes (e.g., mood, depressive symptoms)? Researchers will compare an intervention group, which participates in the game-based exercise program, with a control group that does not receive the intervention, to evaluate changes in health status. Participants in the intervention group will take part in structured game-based physical activity sessions over several weeks, designed to promote engagement, improve physical performance, and support psychological well-being.
NCT07464106
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.
NCT06543745
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.
NCT07458048
Brief Summary This clinical study aims to compare the effects of a conventional exercise program and a Pilates exercise program in prefrail and frail older adults. A total of 40 participants aged 60 years and older who are classified as prefrail or frail according to the FRAIL Scale will be included in the study. Participants will be randomly assigned to either the conventional exercise group or the Pilates group. Both exercise programs will be conducted twice weekly for 6 weeks. The interventions will focus on stretching exercises, balance and perturbation training, and strength exercises targeting major muscle groups. Primary outcomes will include changes in frailty status assessed before and after the intervention. Secondary outcomes will include functional mobility and balance assessed by the Timed Up and Go Test, dynamic balance assessed by the Functional Reach Test, lower extremity strength assessed by the 30-Second Sit-to-Stand Test, gait speed assessed by the 10-Meter Walk Test, depressive symptoms and psychological well-being assessed by the Yesavage Geriatric Depression Scale, independence in daily activities assessed by the Lawton Instrumental Activities of Daily Living Scale, cognitive status assessed by the Mini-Mental State Examination, and fatigue assessed by the Modified Borg Scale. Frailty status will be evaluated using the FRAIL Scale. Throughout the study, participant safety will be monitored, and any adverse events, such as injuries or discomfort occurring during exercise sessions, will be recorded and managed appropriately. This study is expected to provide valuable clinical evidence regarding the effectiveness of conventional exercise and Pilates programs in improving physical health and reducing frailty in prefrail and frail older adults, thereby contributing to the identification of best practice approaches for the management of this vulnerable population.
NCT07335978
The goal of this clinical trial is to investigate the effects of chair exercise followed by intergenerational activity in frailty syndrome and changes in serum mBDN levels among older adults with Physio-Cognitive Decline Syndrome (PCDS), as a novel approach integrating physical and social intervention with biomolecular assessments In older adults with PCDS 1. Does A 16-week program of chair exercise followed by intergenerational activity improve handgrip strength (HGS), gait speed, MoCA-Ina scores, and health-related quality of life? 2. Does a 16-week program of chair exercise followed by an intergenerational activity increase serum mBDNF level? 3. Are serum mBDNF levels associated with MoCA-Ina scores, gait speed, and handgrip strength? Intervention Group Participants will undergo a 12-week structured chair exercise program, conducted with a trained exercise instructor and supervised by a physician for vital sign monitoring during each session. The frequency of sessions will increase progressively: * Weeks 1-2: once weekly * Weeks 3-6: twice weekly * Week 7-12: three times weekly Additional activities include (intervention and control group): * Weeks 1 and 11: teleconference session on nutrition and physical exercise supported by electronic flyers (e-flyers). * Weeks 3, 5, 7, 11, and 13: distribution of e-flyers on elderly nutrition and the muscle-brain axis. Additional Activity (intervention group) \- Weeks 13-16: intergenerational activities at an orphanage with children aged \>5 years Assessments (intervention and control group): * Week 1: serum mBDNF and HbA1c measurement * Week 12 and 16: physical assessments (body weight, height, handgrip strength, gait speed, MoCA-Ina, and IADL) and serum mBDNF measurement. Control Group: The participant will receive general health education on performing physical exercise 1-3 times per week throughout week 1-16
NCT07443046
Hip fractures are common in older adults and are often associated with muscle loss and frailty. While many studies focus on overall muscle reduction (sarcopenia), the role of regional muscle balance around the hip remains unclear. This prospective observational study aims to evaluate whether differences in muscle distribution, particularly between the gluteus medius and psoas muscles measured using computed tomography (CT), are associated with different hip fracture patterns. The study also investigates the potential effects of socioeconomic status, nutritional risk, and comorbidity burden on fracture configuration. Understanding how regional muscle characteristics relate to hip fracture types may provide new insight into biomechanical mechanisms and support future prevention and rehabilitation strategies for older adults.
NCT07419945
The goal of this clinical trial is to learn if a kidney transplant-specific comprehensive geriatric assessment (KT-CGA) can improve the way older adults are assessed for kidney transplantation. The main questions it aims to answer are: Is it feasible and acceptable to deliver a KT-CGA alongside routine transplant assessment in older adults with advanced kidney disease? What is the effect of KT-CGA on decision-making about transplant listing and on patient-reported outcomes such as quality of life and frailty? Researchers will compare participants who receive the KT-CGA plus usual care to those who receive usual care alone. Participants will: Continue with their usual transplant assessment process If randomised to the intervention group, also complete the KT-CGA (a structured set of questionnaires, short memory and function tests, and discussions about wellbeing and support needs, taking about 45-60 minutes)