Clinical Research Directory

Effectiveness of Implementing a Reablement Model in Community-Based Long-Term Care Centers

This study will examine whether a reablement approach can help people receiving community-based long-term care maintain or improve their independence, daily functioning, and quality of life. Approximately 300 adults from eight long-term care facilities across Taiwan will participate. The 12-week reablement program includes group and individualized activities designed to support mobility, cognitive function, daily activities, and social participation. Participants' physical and cognitive function, daily living abilities, emotional well-being, quality of life, and personal goals will be assessed before and after the program. The study will also include observations and interviews with care providers, participants, and family members to understand their experiences with the program and identify factors that support successful implementation. The findings are expected to help develop a practical reablement model for community-based long-term care in Taiwan and provide guidance for improving care quality, independence, and healthy aging.

FICB for Hip Fracture Pain in Elderly

Hip fracture is a common injury in elderly patients, often requiring surgical treatment. However, these patients frequently experience severe postoperative pain, which can delay mobility and recovery, and increase the risk of complications such as delirium, pneumonia, and prolonged hospital stay. The fascia iliaca compartment block (FICB) is a regional anesthesia technique that has been shown to provide effective pain relief for hip fracture patients. This study aims to investigate whether early administration of FICB, performed upon hospital admission before surgery, can improve postoperative rehabilitation outcomes in elderly patients with hip fracture. This is a prospective, randomized, controlled study. A total of 144 elderly patients with hip fracture will be randomly assigned to either the FICB group or the control group. The FICB group will receive ultrasound-guided FICB after being admitted to the orthopaedic ward, while the control group will receive standard analgesic care once inside the operating room. The primary outcome measure is Quality of Recovery-15 score (QoR-15 score) 24 hours post-surgery. Secondary outcomes include: QoR-15 score at 48 hours postoperatively, NRS scores and sleep duration and quality scores at preoperative and various postoperative time points, total perioperative consumption of opioids and other analgesic drugs, extubation time and emergence agitation during anesthesia recovery period, incidence of delirium from postoperative period to before discharge, length of hospital stay, and overall satisfaction score with pain management. The hypothesis of this study is that early FICB intervention, compared to standard care, will lead to better pain control, earlier mobilization, shorter hospital stay, and improved overall postoperative recovery in elderly patients with hip fracture.

Iron Status Assessment in Geriatric Elderly

In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status. The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays. The study will be conducted in two distinct phases: a pilot phase involving up to 200 patients at a single center in France, followed by a main phase involving 1,523 patients across multiple centers in France. Participants will be adults aged over 75 years who are hospitalized in a geriatric ward and present with an acute inflammatory episode (C-reactive protein \[CRP\] \> 50 mg/L). In addition to routine analyses performed during hospitalization, supplementary laboratory analyses will be carried out. Following admission in hospital, patients will receive standard medical care. Upon admission or on the following day, patients, their trusted representative, or relatives will be informed about the study. If eligibility criteria are met, the patient will be enrolled. Research-specific laboratory analyses will be performed on blood samples collected at 4 times: * the day after admission; * when CRP \< 20 mg/L (pilot phase only); * when CRP \< 10 mg/L; * five days after a CRP \< 10 mg/L. These additional analyses will not require another blood sample, as they will be performed on samples collected as part of routine clinical care. They constitute the main research specific intervention.

Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation

ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure. The study compares two established treatment strategies: 1. Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and 2. Optimized medical therapy without AF ablation (medications for rate and/or rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care). Participants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time. The study has two primary endpoints, tested with Holm-Bonferroni multiplicity control assessed over 24 months: 1. a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and 2. patient-reported health-related quality of life (HRQoL), measured by the RAND-36 "General Health" domain. ACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.

AI-Based Risk Factor Analysis and Prediction Model of MACE in Elderly Hip Fracture Patients Postoperatively

This is a multicenter ambispective observational cohort study led by Beijing Anzhen Hospital, Capital Medical University, with China-Japan Friendship Hospital serving as the external validation center. Major adverse cardiovascular events (MACE) occurring after surgery are common complications among older adults undergoing hip fracture surgery and are associated with poor long-term outcomes, including increased one-year mortality. Previous studies have not systematically evaluated perioperative risk factors or developed prediction models specifically for this population. In addition, conventional statistical approaches may have limited ability to account for complex interactions and nonlinear associations among multiple perioperative variables. Therefore, this study aims to identify risk factors for postoperative MACE and to develop and externally validate a machine learning-based prediction model. Patients aged 60 years or older who undergo surgical treatment for hip fracture will be included. The derivation cohort, established at Beijing Anzhen Hospital, will be used for model development and internal validation, whereas the independent external validation cohort, established at China-Japan Friendship Hospital, will be used to evaluate the generalizability and predictive performance of the developed model. The study will adopt a bidirectional cohort design: one portion of the study population will be identified retrospectively from electronic medical records, and the remaining participants will be consecutively enrolled prospectively following ethics committee approval. Postoperative outcomes will be ascertained from the end of surgery until the earliest occurrence of hospital discharge, death, or postoperative day 30. Standardized, de-identified data will be collected, including demographic characteristics, comorbidities, laboratory findings, surgical and anesthetic information, perioperative medications, and postoperative MACE outcomes. No study-specific intervention will be assigned, and all patients will receive routine clinical care. Data will be managed in accordance with institutional privacy policies and applicable data protection requirements. Candidate predictors will be evaluated using univariable analyses, least absolute shrinkage and selection operator regression, and random forest-based feature selection. Prediction models, including logistic regression, XGBoost, and LightGBM, will be developed in the derivation cohort. Internal validation will be performed using resampling methods, and external validation will be conducted using data from the independent validation center. Model performance will be assessed in terms of discrimination, calibration, and clinical utility using the area under the receiver operating characteristic curve, calibration plots, and other appropriate performance measures.

Hybrid Group Singing

The overall objective of the planned future clinical trial is to test the investigator's central hypothesis that habitual singing over several weeks, similar to habitual exercise, will lead to sustained and favorable vascular adaptation, thereby lowering cardiovascular disease (CVD) risk. The overall objective of this study is to refine and protocolize the singing interventions and test the feasibility of the future trial design. The investigative team has previously studied solo singing. Collective singing, as in a choir or small group, is associated with a positive sense of social inclusion, well-being, and improved mood, including in older adults.

Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly

Benzodiazepines or related drug (BZDR) are consumed for hypnotic or anxiolytic purposes in most cases. The consequences of BZDR are multiple with an increased risk of daytime sedation, balance disorders leading to falls and fractures, cognitive disorders, road accidents and dementia. Given their comorbidities, physiological changes, and multiple medications, the elderly are more at risk of suffering from BZDR adverse events. Interprofessional collaboration has shown efficacy in improving prescribing appropriateness and may affect patients outcomes positively. Morever, motivational interviews (MI) may reduce the extent of substance abuse compared to no intervention.

Effectiveness of a Physical Activity Program

study with multicomponent exercise

Personalized Rehabilitation Program for Elderly Patients That Fall

The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death. The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.

Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)

Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.

Physical and Physiological Demands of Different Recreational Team Handball and Walking Modalitiesmodalities

This study aims to determine the physical and physiological demands and perceived experience during different recreational team handball and walking exercise modalities. Secondary purposes are: i) To compare the cardiovascular and blood lactate responses to self-paced walking (W), brisk walking (BW), recreational walking team handball (WTH), and recreational running team handball (RTH); ii) To compare the perceived experience (Rating of Perceived Exertion (RPE) and Fun levels (FUN)) during self-paced walking (W), brisk walking (BW), recreational walking team handball (WTH), and recreational running team handball (RTH); iii) To compare the activity profile during self-paced walking (W), brisk walking (BW), recreational walking team handball (WTH), and recreational running team handball (RTH);

Validity and Reliability of the Turkish Form of the Enjoyment of Physical Activity Scale-8 in Geriatrics With Minimal Cognitive Impairment

The main objective of this study is to examine the validity and reliability of the Turkish form of the Enjoyment of Physical Activity Scale-8 (PACES-8) in individuals aged 65 and over with Minimal Cognitive Impairment (MCI).

Validity and Reliability of the Exercise-Related Health Beliefs Attitude Scale in Geriatric Individuals

The main purpose of this research is to test the validity and reliability of the "Exercise Health Beliefs Attitude Scale" (EYSİTÖ), developed by Caz, Paktaş and Yazıcı (2023) for adult individuals, in geriatric individuals aged 65 and over.

Comparison of Hand Grip Strength in Different Shoulder Positions in Geriatric Individuals: Position-Dependent Strength Analysis

The aim of this study is to examine the relationship between hand grip strength, measured in different shoulder positions, and upper extremity muscle strength, and to reveal the clinical significance of position-dependent strength variation.

Successful Aging and Age-related Decline

Recent studies have shown promising cognitive and physical interventions aimed at slowing down ageing-related declines in quality of life, but they lack strong ecological validity (brief durations, unrealistic goals, no real-world application) and has yet to show robust evidence that such interventions are stable and suitable in the long-term. The investigators aim to examine whether these interventions can, over four years, significantly slow down the normal rate of ageing-related decline.

SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70

The goal of this clinical trial is to compare two treatment options-surgery or rigid collar bracing-for unstable neck fractures (odontoid fractures) in adults aged 70 years and older. These fractures are common in older adults and can significantly impact mobility, independence, and quality of life. There is currently no clear evidence to determine which treatment is better for this population. The main questions it aims to answer are: * Does surgery or conservative collar treatment lead to better improvement in daily living, measured by the Barthel Index, after 12 weeks? * What are the differences in pain, disability, and quality of life between the two treatments? The study team will compare patients who receive surgical stabilization with those who are treated with a rigid cervical collar to see which approach supports better functional outcomes and healing. Participants will: * be randomly assigned to either surgery (posterior C1-C2 screw-rod fixation) or conservative collar treatment * attend study visits at 12 weeks and 6 months * complete questionnaires on daily functioning, pain, and quality of life * undergo CT scans and other medical assessments * record collar use (for conservative group) in a diary * be monitored for any complications or changes in treatment (including crossover to surgery if needed) The study aims to include 322 participants to provide evidence on which treatment helps older adults recover better from odontoid fractures with fewer complications and improved quality of life.

Validity and Reliability of the Exergame Enjoyment Questionnaire (EEQ) in Turkish

The aim of this research is to adapt the Exergame Enjoyment Questionnaire (EEQ) into Turkish and to evaluate its suitability for the Turkish elderly population through validity and reliability analyses. After the cultural adaptation process is completed, the construct validity of the scale will be evaluated using exploratory and confirmatory factor analyses; its reliability will be assessed through internal consistency coefficients (Cronbach's alpha) and test-retest reliability over time (ICC). Accordingly, the study aims to provide a valid and reliable assessment tool for clinicians and researchers who wish to evaluate individual experiences in exergaming-based interventions.

The Effect of Home Based Fall Prevention Program on Older Adults at High Risk of Falling

Fall prevention programs that implement and evaluate fall rates, balance status, accidents related to falls and hospital admissions, exercise status, muscle strength, fear of falling, and quality of life can be effective interventions for healthy aging by minimizing the risk of falls in elderly individuals. In this doctoral dissertation study, it was aimed to evaluate the effect of a nurse-led home-based fall prevention program on fall rate, balance level, fall risk score, fear of falling, number of hospital admissions due to falls, quality of life, and in-home safety conditions in older adults with high fall risk.

Impact of Esketamine on Delayed Neurocognitive Recovery in Older Patients

Esketamine is frequently used during the perioperative period for supplemental analgesia. Small sample size trials showed that subanesthetic dose esketamine may decrease postoperative neurocognitive complications. However, conflicting results exist and optimal dose of esketamine remains to be determined. This dose-exploring pilot trial is designed to evaluate the safety and efficacy of three different perioperative esketamine dosing regimens in older patients undergoing major non-cardiac surgery. The primary purpose is to explore the optimal dosing strategy that produce maximal neurocognitive benefits with minimal adverse neuropsychiatric symptoms.

Remote Monitoring to Prevent Frailty Progression in the Elderly

Frailty is a frequent condition in elderly, characterized by reduced physiologic reserve, leading to an increased risk for adverse events, such as disability, hospitalization, and death. In particular, it is a multidimensional disfunctional condition, including decreases in physiologic capacity in neurologic control (indicated by diminished ability to perform complex tasks), mechanical performance (e.g. diminished strength), and energy metabolism (e.g. decreased aerobic status due to cardiac or pulmonary diseases or both). All these factors lead to the worsening of quality of life. Focusing on the great impact of this condition in global population and the rising of social/health costs, related to this condition, frailty is earning a great interest from both at political level and European Community. For this reason, developing interventions programs aiming to prevent the progression of frailty towards the independence loss, it is considered a key objective for the improvement of the quality of life. In this context, this pilot study looks at the standardization of a study protocol to develop a useful model for enhancing local care in small population isolates, by remotely monitoring the health status of pre-frail subjects and improving the progression of the frailty condition, in order to support a healthy ageing for future investigation including a larger number of individuals.

Effect of Vegetarien Diet on Protein Digestibility in Young and Elderly Volunteers

Plant proteins are usually less digestible than animal proteins, but they may benefit gut health through effects on the microbiome. The long-term impact of diets rich in plant products on protein digestion and metabolism is still unknown, especially in older adults with higher protein needs. This study aims to compare the digestion and use of pea proteins in young and older adults, both vegetarians and omnivores. Volunteers are divided into four groups: young omnivores, young vegetarians, older omnivores, and older vegetarians. They take part in two clinical investigation days. On the first day, nitrogen retention and protein metabolism is measured after consumption of a pea-based meal. On the second day, amino acid digestibility of pea is evaluated. These results will provide valuable data on how plant proteins are digested and metabolized depending on age and diet. They will also help determine whether aging reduces the availability of plant proteins. This knowledge is important to support nutritional strategies for populations with specific protein needs, such as older adults.

MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients

This is a single-center, prospective, single-arm interventional study with historical control, designed to evaluate the clinical value of a multidisciplinary team (MDT)-based decision-making umbrella decision model in elderly patients with lung cancer. A total of 2,000 patients aged 60-90 years with newly diagnosed non-small cell or small cell lung cancer will be enrolled. Each patient will undergo comprehensive geriatric assessment and receive an individualized treatment plan formulated by an MDT comprising thoracic surgeons, geriatricians, oncologists, pulmonologists, rehabilitation therapists, and radiologists. Treatment options include surgery, ablation, stereotactic body radiotherapy (SBRT), neoadjuvant immunochemotherapy, targeted therapy, and best supportive care. The primary outcome is 3-year progression-free survival (PFS). Secondary outcomes include overall survival, objective response rate, quality of life (EORTC QLQ-LC43), incidence of adverse events (CTCAE v5.0), and healthcare economics. Historical controls (2014-2024) will be extracted from hospital records and matched using propensity score matching. The study aims to establish a standardized MDT pathway to improve treatment outcomes and reduce risks in the geriatric lung cancer population.

Elderly Patients Undergoing Surgery During Perioperative Period

The elderly patients have poorer overall conditions and have lower tolerance to trauma, anesthesia, and surgery. Therefore, the incidence of postoperative complications is relatively higher. In non-cardiac surgeries, approximately 20% of elderly patients experience postoperative complications, and the incidence of postoperative delirium (POD) is 23.8%. This may lead to prolonged hospital stays, increased hospital costs, and affect prognosis and even mortality. The investigators plan to conduct a prospective cohort study by systematically collecting biological samples and clinical information of elderly patients during the perioperative period to explore the possible risk factors and pathogenesis of postoperative delirium and postoperative complications in elderly surgical patients, and to construct a risk prediction model for postoperative complications.

Aurora: AI-Based Narrative Intervention to Support Emotional Well-Being in Clinical and Non-Clinical Populations

Aurora is an interdisciplinary project evaluating a chatbot-mediated supportive care intervention designed to promote emotional expression, autobiographical meaning-making, identity processes, and emotional well-being through guided narrative reconstruction. The Aurora system provides a structured, person-centered storytelling process supported by generative AI and human facilitation. Under the supervision of a trained facilitator (licensed mental health professional), participants engage in guided reminiscence and storytelling sessions to co-create a personalized "life book." The chatbot is not a diagnostic or treatment tool; rather, it is intended to support emotional expression, narrative reconstruction, and recovery-oriented processes. The study includes three non-randomized arms implemented sequentially: (1) a single-session arm of healthy adults focused on acceptability, usability, and emotional safety; (2) a four-hour intervention arm of adults with DSM-5 diagnosed mental disorders in residential care; and (3) a four-hour intervention arm of healthy older adults aged 65 years and older. Quantitative outcomes assess affect, mental well-being, and recovery-related constructs. Additional measures include usability, satisfaction, and qualitative feedback. Ecological momentary assessment (EMA) is conducted in Arms 2 and 3.