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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.
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.
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.
NCT06820021
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.
NCT05877846
The investigators aim to conduct a 12-week, single-arm, pre/post-intervention of b-hydroxy-methylbutyrate in persons aged 65 to 85 years to assess feasibility and acceptability of the intervention and study procedures, secondary outcomes of physical function and changes in multi-omics patterns, and exploratory outcomes that will allow the team to describe physical function phenotype. The investigators' primary outcomes are the: feasibility of the study procedures (including safety), feasibility of the intervention delivery, and acceptability of study procedures and measures. Secondary outcomes include: Objective and subjective physical function measures that predict disability including the 30-second sit-to-stand, knee strength, isokinetic strength, grip strength, gait speed, 400-m walk test, Pittsburgh Fatiguability, PROMIS global health-10, social support, anthropometry, National Institutes of Health (NIH) Cognitive toolbox, Automated Self-Administered 24-hour Dietary Assessment (ASA-24), Community Healthy Activities Model Programs (CHAMPS), Ultrasound Imaging, Magnetic Resonance Imaging (MRI), Changes in untargeted metabolomic profile data based on qualitative or semiquantitative analysis of the most probable detectable metabolites in laboratory samples , Discover potential metabolites that explain changes in physical function using a discovery science, precision medicine approach (discovery science approach that is exploratory)
NCT07384169
Procedures such as colonoscopy cause discomfort and pain and are therefore performed under sedation and analgesia. Although patients aged 65 and older frequently undergo colonoscopy procedures, it is unclear to what extent the anesthetic agents administered for sedation and analgesia in this patient group affect neurocognitive functions. Different sedation methods are used in colonoscopy procedures depending on the anesthesiologist's choice. Propofol is an agent frequently used in general anesthesia or for sedation during endoscopic procedures and, compared to inhaled agents, has more positive effects on postoperative cognitive functions. Dexmedetomidine is an alpha receptor agonist and is preferred due to its positive effects on cognitive functions in elderly patients, its lack of respiratory depression, its ability to provide sedation without impairing cooperation, and its analgesic effects. Although there are studies in the literature on the assessment of neurocognitive function in geriatric patients undergoing surgical procedures, the literature is insufficient in terms of studies addressing cognitive assessment after short-term, outpatient, and less invasive procedures such as colonoscopy. This study aimed to observe patients aged 65 years and older who underwent sedoanalgesia for colonoscopy and to compare the effects on cognitive function by administering the mini mental test before and after the procedure to this patient group.
NCT06470308
Polypharmacy is a common and growing public health concern across healthcare settings worldwide and is associated with an increased risk of inappropriate prescribing and adverse drug events. Deprescribing-defined as the supervised withdrawal of potentially inappropriate medications using structured tools and clinical judgment-has been proposed as a strategy to improve prescribing safety. In Greece, formal initiatives and evidence evaluating deprescribing interventions in primary care remain limited. This study is a cluster randomized controlled trial evaluating the effect of an educational intervention for general practitioners (GPs) on prescribing safety in primary care. Participating GPs are randomized in an approximately 1:1 ratio to an intervention or control arm. GPs in the intervention arm receive structured education and training on medication review and deprescribing, including the use of validated deprescribing tools such as the Beers Criteria. GPs in the control arm provide usual care and do not receive any educational intervention. Patients receiving care from participating GPs are recruited, and prescribing outcomes are assessed at the patient level. The primary outcome is change in prescription medications following the intervention, comparing patients cared for by GPs in the intervention arm versus those cared for by GPs in the control arm.
NCT07379099
The ICOPE (Integrated Care for the Elderly) program is based on an integrated approach including a personalized care plan (PCP). Negotiation methods with the patient and interprofessional cooperation could be key elements in the success of this program. The main objective is to evaluate the feasibility of the implementation of the ICOPE program on the number and content of the PCP carried out at 1 year
NCT07207044
FAXAge is a randomized controlled trial investigating the effects of fasting and exercise on human aging. 240 participants over the age of 65 will be divided into 4 groups - an exercise group, a fasting group, a combined exercise and fasting group and a control group. The intervention will last for one year, and tests of biomarkers of aging will be performed at baseline, after 3 months, 6 months and at the end of the intervention. A reference group of participants over the age of 20 equally distributed by age and sex will be used to train an algorithm for determination of biological age. The study will include both physical, molecular and digital biomarkers including DNA-methylation, VO2max, body composition and face- and voice-age. The main outcome of the project is DNA-methylation age at week 52. Secondary outcomes are the rest of the tested biomarkers at week 52. It is hypothesised that the intervention groups will have similar superior benefits after the 52 weeks of intervention.
NCT07351526
Rehabilitation improves health outcomes, reduces disability and improves quality of life. There is a significant and emerging body of international evidence to support the benefit and cost effectiveness of specialist rehabilitation services within a modern health service. The demand for rehabilitation services is growing with changes in populations and with the advances in health care and new interventions and technology. Our overall aim is to explore the outcomes and clinical characteristics of adults who are admitted to a rehabilitation hospital in the Midwest region of Ireland during admission, at the time of their discharge and at 6 months.
NCT07344662
This study aimed to determine the effect of hemsball activity on balance, kinesiophobic attitudes, and frailty levels in older male individuals. The research was conducted as a parallel-group pre-test-post-test randomized controlled trial. The reporting of the study utilized the CONSORT 2017 extension evaluating non-pharmacological interventions. The study was conducted with 86 older male individuals using a parallel-group pre-test-post-test randomized controlled trial design. The hemsball activity was structured by the research team and lasted for eight weeks, three days a week, for 60 minutes each day. Data were collected using pre-tests planned before randomization, immediately after obtaining written consent from the individuals, and post-tests in the eighth week of the study. Data were collected using a Personal Information Form, the Berg Balance Scale, the Tampa Kinesiophobia Scale, and the Edmonton Frailty Scale. Data were analyzed using a generalized linear model. This research found that hemsball activity is an effective intervention in improving balance and reducing kinesiophobia and frailty in older male individuals. Through this research, a new type of intervention that improves balance and reduces kinesiophobia and frailty levels in older individuals has been added to the literature.
NCT07322744
Both frailty and a reduced preoperative lymphocyte-to-monocyte ratio (LMR) are known risk factors for postoperative delirium (POD). However, whether the relationship between LMR and POD varies by frailty status remains unclear. This study aimed to evaluate the frailty-stratified association between preoperative LMR and POD in older surgical patients.
NCT05047731
Frail older adults are commonly prescribed blood pressure medication, yet it is unclear if blood pressure medication is actually beneficial for them. Observational studies in this population suggest blood pressure medication has limited benefit and may even be harmful, including an increased risk for falls and cognitive impairment. Randomized controlled trials are needed to confirm this. This study is a randomized controlled trial of blood pressure medication deprescribing, amongst long-term care residents with systolic blood pressure lower than 135 mmHg. In the intervention group, with physician consent, the facility pharmacist or nurse practitioner will continually reduce antihypertensives provided an upper systolic threshold of 145 mmHg is not exceeded. The control group will receive usual care. The hypothesis is that avoiding unnecessarily low systolic blood pressure is beneficial in a frail, end-of-life population.
NCT04221750
The continuing increase in prevalence of obesity in older adults including many older Veterans has become a major health concern. The clinical trial will test the central hypothesis that a multicomponent intervention consisting of lifestyle therapy (diet-induced weight loss and exercise training) plus metformin will be the most effective strategy for reversing sarcopenic obesity and frailty in older Veterans with obesity.
NCT06623019
It is a cross-sectional, randomized, and single-center study with a duration of 6 months. The study will follow the STROBE guidelines for cross-sectional studies and CONSORT 2024. The main objective is to evaluate the validity and reliability of two devices in measuring grip strength and muscle fatigability in community-dwelling older adults.The study will include community-dwelling older adults of both sexes over 60 years of age.