Clinical Research Directory

Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults

With the global aging trend, the management of geriatric risks faced by older adults and the effectiveness of health education for this population are gaining increasing importance. Literature indicates that health education for older adults, when delivered through methods that support individual engagement and the use of digital tools, yields more effective results in terms of learning and behavior change. This doctoral study aims to evaluate the effect of a digital education model, structured based on the Health Belief Model and developed using branching scenario animation technique, on geriatric risk knowledge level and frailty status among older adults residing in nursing homes. The study will be conducted as a randomized controlled trial in three nursing homes in Istanbul, with measurements at baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3). Based on power analysis, 66 participants will be randomly assigned to intervention and control groups (33 per group) using block randomization. The intervention group will receive scenario-based digital animation education developed on the Vyond platform and structured according to the theoretical components of the Health Belief Model. The control group will receive standard care during the study period and will be offered the same digital animation education after completion of all assessments (post 3-month follow-up). The primary outcome is geriatric risk knowledge level, assessed using an interactive digital game called "Knowledge Wheel." Secondary outcomes include frailty status, measured by the Edmonton Frail Scale, and technology acceptance. Changes in knowledge and frailty levels measured through assessment tools will reveal the short- and medium-term effects of the education. Thus, the model's impact on health-related behavior change in older adults will be comprehensively evaluated. The unique aspect of this study is that it will be one of the first experimental studies to implement an interactive scenario-based digital education model in older adults. The findings are expected to contribute to the development of age-friendly health education models.

Effects of a Multidisciplinary Intervention on Muscle Strength, Posture, and Balance in Older Adults After an Earthquake

This randomized controlled trial evaluated the effects of a 12-week multidisciplinary intervention on muscle strength, postural alignment, and balance in older adults living in temporary container settlements following the February 2023 earthquakes in Kahramanmaraş, Türkiye. A total of 60 adults aged 65 years and older were allocated to an intervention group (n=30) or a control group (n=30). The intervention group participated in an individualized health management program that included exercises targeting muscle strength, balance, mobility, and posture, together with nutritional counseling, psychosocial support, and health education. The control group received no active intervention and underwent assessments at baseline and after 12 weeks. Muscle strength was assessed using digital and manual dynamometers. Postural alignment was evaluated using PostureScreen, while postural sway and balance were assessed using Gyko and functional performance tests, including the Timed Up and Go Test and Short Physical Performance Battery. The study aimed to determine whether a multidisciplinary intervention could improve physical function, postural alignment, and balance in older adults living in post-disaster temporary housing.

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.

Hybrid III Trial of Automated Referral to Comprehensive Geriatric Assessment for Frail Older Surgical Patients

The goal of this observational study is to learn about automated referrals to Perioperative Optimization of Senior Health (POSH). The main question it aims to answer is: * Do automated referrals to POSH increase the number of people who attend the clinic?

Zanubrutinib Plus Lenalidomide for Frail Elderly Patients With Newly Diagnosed PCNSL

This is a prospective, single-arm, phase II clinical study evaluating the efficacy and safety of Zanubrutinib (a BTK inhibitor) plus Lenalidomide (an immunomodulatory drug) in frail elderly patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The study plans to enroll 33 patients who are aged ≥ 70 years and classified as frail, a population for whom standard first-line treatment regimens, high-dose methotrexate-based chemotherapy, may be "unfit". This study includes screening phase, induction phase, consolidation phase and maintenance phase. The screening period is defined as within 1 week prior to the first dose. During induction, participants will receive Zanubrutinib 160 mg orally twice daily continuously and Lenalidomide 25 mg orally once daily on days 1-21 of each 28-day cycle for three cycles. Participants who achieve a partial response (PR) or complete response (CR) after induction will receive three additional 28-day consolidation cycles of the same regimen. Participants who achieve a CR after consolidation will continue maintenance treatment with Zanubrutinib and Lenalidomide until disease progression. Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria and assessed every 3 months. The primary endpoint is the complete response rate (CRR) at the end of induction therapy. Secondary endpoints include overall response rate (ORR) at the end of induction therapy, CRR and ORR at the end of consolidation therapy, One-year and two-year progression-free survival (PFS) rates, Duration of response (DOR), overall survival (OS), adverse event (AE) and serious adverse event (SAE). Exploratory liquid-biopsy analyses will be performed to evaluate treatment response and prognosis.

Functional Changes and Fall Risk in Older Adults Participating in a Frailty Program

This prospective observational study aims to describe changes in physical function and fall risk in adults aged 70 years and older participating in a routine multicomponent frailty and falls prevention program in primary care. Participants are evaluated before and after the intervention, and additional postural control variables are recorded using a pressure platform without modifying routine clinical care.

Targeting Aging With a Ketone Ester for Function in Frailty

This study aims to find out if a food supplement that contains a naturally occurring substance, ketones, can help to improve strength and general wellness in adults at, or over the age of 65 years who are experiencing a slight decline in their physical function. Participation will involve a screening visit and 4 additional study visits over the course of 20 weeks. After being assessed for eligibility, study participants will be sorted into two groups at random and consume either a ketone or placebo supplement at home every day for 20 weeks. Both study products can cause gastro-intestinal side effects in some individuals. At all study visits, subjects will provide blood samples. At three study visits, subjects will be asked to complete physical performance tests, provide blood, stool and urine samples. They will also complete questionnaires during three study visits to assess physical function, markers of inflammation, and other aspects of general well-being. The study enrolls at three sites across the United States, in California (Buck Institute), Ohio (Ohio State University), and Connecticut (University of Connecticut). The study is coordinated by the San Francisco Coordinating Center (California Pacific Medical Center).

Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults

The long-term goal of this project is to effectively bridge the research-clinic-community gap and to foster partnerships that support the implementation, utilization, and advocacy of evidence-based fall prevention programs in the older adult community. The Otago Exercise Program (OEP) is an evidence-based fall prevention program that has been shown to reduce falls and fall-related injuries among older adults. Traditionally, OEP is delivered in the home by a physical therapist and focuses on muscle strengthening and balance training. Despite its proven effectiveness, adherence and compliance rates have been low. The personnel and resource demands of program delivery, along with challenges in monitoring participant adherence, represent significant barriers to broader implementation. Alternative delivery systems using remote and community-based platforms may help address these limitations. Specific Aim 1: To compare the effectiveness of two delivery modes of the Otago Exercise Program: a remotely delivered, home-based smartphone program and an in-person, community-based program. Specific Aim 2: To examine the feasibility, acceptability, and usability of the Otago Exercise Program delivered through both smartphone-based and in-person formats.

Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) for Frail Older Adults in Primary Care

Frailty is a multidimensional clinical syndrome associated with increased vulnerability to adverse health outcomes in older adults. Despite strong evidence supporting multicomponent exercise interventions, their implementation in primary care settings remains limited. This randomized controlled trial aims to evaluate the efficacy of the FRAIL+AP program, which integrates Comprehensive Geriatric Assessment (CGA) with a 12-week multicomponent exercise intervention, including visual-spatial gait retraining using the Tapiz Fisior system. The study will assess whether this intervention improves frailty status, physical performance, and functional independence, while reducing falls among community-dwelling older adults compared to standard care.

Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II

This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases scheduled for elective lumbar fusion surgery, and they will be randomized 1:1 into the intervention and usual care groups. The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program, including multicomponent exercise, nutritional intervention, comorbidity optimization, and cognitive prehabilitation with brain protection strategies. The control group will receive standard health education provided via a manual, and both groups will receive consistent perioperative Enhanced Recovery After Surgery care. The primary outcome will be the change in Barthel Index (a tool for assessing independence in activities of daily living) from baseline to 30 days postoperatively; secondary outcomes will include pain scores, disability, patient satisfaction, and the 30-day postoperative Comprehensive Complication Index. The trial will initiate recruitment in April 2026 and conclude in December 2027, aiming to evaluate the feasibility and efficacy of PHYSIO-Prehab and provide high-quality evidence for patient-centered perioperative care pathways in this population.

The Effect of Teleconsultation, on the Reversibility of Frailty in Geriatric Patients Post Hospitalization

The goal of this clinical trial is to learn if a structured tele-consultation program, delivered 3 times over 12 weeks, can improve (reverse) frailty in geriatric patients recently discharged from the hospital. The main questions it aims to answer are: * Does structured tele-consultation covering physical exercise, nutrition, and home care education change health behavior in older adults after hospital discharge? * Does this change in health behavior lead to improvement in frailty, as measured by Clinical Frailty Scale (CFS) score? * Does this change in health behavior lead to improvement in frailty, as measured by decreased interleukin-6 (IL-6) and myostatin levels and increased albumin levels? * Does this change in health behavior lead to improvement in frailty, as measured by increased hand grip strength? Researchers will compare participants receiving structured tele-consultation (delivered 3 times over 12 weeks) to participants receiving usual care to see if tele-consultation leads to greater improvement in health behavior and frailty status. Participants will: * Undergo baseline assessment of CFS score, hand grip strength, and blood sampling for IL-6, albumin, and myostatin shortly after hospital discharge * Be randomly assigned to receive either structured tele-consultation (3 sessions over 12 weeks, covering physical exercise, nutrition, and home care education) or usual care * Undergo repeat assessment of health behavior, CFS score, hand grip strength, and the same blood markers at the end of the 12-week period

Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults

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.

Fine-tuned Physical Training to Improve Quality of Life in Older Individuals

The overall aim of this project, which is based upon the interdisciplinary expertise of four research groups within the University of Rome Foro Italico, in the macro-areas of psychology, bioengineering, physiology, and internal medicine, is to improve the overall health and well-being of community-dwelling frail older adults, who are often suffering from non-communicable diseases, by means of an integration of innovative cognitive and resistance-core training. Forty-five frail or pre-frail community-dwelling older adults aged ≥65 years will be randomly assigned to three 8-week intervention groups: A) resistance training; B) resistance-core training; C) cognitive-resistance-core training. Comparison between groups C and B will show the effects of an innovative cognitive-motor dual-task training method, which will incorporate principles of modern psychotherapeutic approaches to boost physical training, and to improve cognitive, emotional, and mood disturbances in older ages. Comparison between groups B and A will focus on the motor component of the intervention, showing the effects of adding specific core-exercises to a traditional resistance training program on muscle strength, power, and the ability to safely carry out functional abilities of daily life. As outcomes, clinical and psychological scales, cognitive tasks, and their underlying cortical mechanisms will be measured. In addition, state-of-art physiological and biomechanical methods will be used to study human kinematics, muscle synergies, and cortico-muscular coherence furthering some important neurophysiological mechanisms of motor control underlying the execution of functional tasks. The results of this project, therefore, will be of great relevance for the advancement of training-exercise methodology as well as unravelling central and peripheral mechanisms underlying frailty with the final goal of improving the quality of life in older individuals.

Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

High Intensity Interval Training Versus Moderate Intensity Continuous Training in Frail Elderly

The assessment and systematic integration of physical activity into the care pathway of frail elderly people is essential to prevent loss of independence and improve the quality of life of this population. This project, which is part of routine care, aims to evaluate the practices and, in particular, the effects of different types of physical exercise currently in use at the Health and Sport Center of the Grenoble Alpes University Hospital. It therefore aims to optimize professional practices without changing the standard care provided to patients. Recommendations regarding intensity during cardiorespiratory endurance training sessions (moderate to high, taking into account emotional factors) are broad and vary greatly in their application depending on the facilities that work with older adults. This project aims to compare the exercise methods used on ergocycle at Health and Sport Center of Grenoble Alpes University Hospital: high-intensity interval training (HIIT) vs. moderate-intensity continuous training (MICT) to reverse the functional decline that occurs in frail older adults.

Comparison of the Effects of Different Exercise Protocols in Frail Elderly Individuals

The aim of this research is to investigate and compare the effects of two different exercise programs developed for frail geriatric individuals on fall risk, fear of falling, and physical performance.

Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

The current study seeks to examine the prevalence of amyloid pathology, among patients referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We also aim to fully characterize the clinical progression of frail cognitively impaired patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive impairment but do not have AD pathology.

Community-Based Program Integrating Nurse-Led Mind-Body Exercise and Nutrition for Frailty

This study aims to develop and evaluate a community-based rehabilitation program integrating nurse-led mind-body exercises and nutritional supplementation for frail older adults in Indonesia. This study uses a Randomized Controlled Trial (RCT) with three parallel groups and assessor blinding. The intervention was conducted for 8 weeks in community-dwelling older adults aged ≥ 65 years who live within the working area of a Community Health Center in Surabaya City. The sample size is 48 elderly. Participants will be divided into 3 groups: the control group, the Nurse-Led Mind-Body Exercise group, and the MBE + Nutritional Supplementation (MBE + Nutrition) group. The procedure is carried out after respondents provide voluntary consent. Confidentiality and anonymity of data will be strictly maintained throughout the research process. Data analysis between groups and within groups will be conducted using repeated-measures ANOVA and Intention-to-treat (ITT) analysis.

Comparative Effects Of Exergaming And Otago Exercise On Anticipatory Postural Control And Sensory Integration In Older Adults

This study explores whether non-immersive, interactive Exergaming using Xbox Kinect can go beyond conventional exercise by actively training the brain and body to react faster, balance smarter, and move more confidently. Through dynamic games like Reflex Ridge and 20,000 Leaks, we aim to stimulate internal perturbations and real-time Sensory Integration, something Otago doesn't directly target. In this randomized controlled trial, 36 older adults (aged 55+) will be assigned to either the Exergaming or Otago group. Both groups will receive 6 weeks of supervised balance training (3x/week, 30 mins/session). Primary outcomes include Sensory Integration, measured using modified Clinical Test of Sensory Interaction and Balance (mCTSIB) and Anticipatory postural control assessed through Limits of Stability (LOS) test. Timed up and Go (TUG) will capture functional mobility, which will serve as the secondary outcome in this study. Both mCTSIB and LOS will be administered using the Postural Stability System of Biodex, a reliable and valid computerized platform designed to objectively quantify postural control under varying sensory conditions. With evidence-based outcome tools and rigorous analysis, this project doesn't just aim to compare two programs, it's about challenging tradition, modernizing rehab, and making balance training smarter, safer, and more engaging for the elders we serve. This research could be a leap forward in community-based fall prevention and a step toward a more responsive, personalized future in Neurological Rehabilitation.

FreeFrail Project: A Multicomponent Intervention for the Management of Frailty in Primary Care: A Randomized Controlled Trial

The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Secondary objectives include evaluating its impact on pain, anxiety or depression, sleep quality, quality of life, physical activity, handgrip strength, and polypharmacy. A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida. Frail older adults (≥65 years) will be recruited and randomly allocated to either the intervention group, receiving a structured cognitive-motor dual-task based multicomponent program, or the control group, receiving usual care. Outcomes will be assessed using validated tools at baseline and follow-up.

Frailty in Hip or Knee Arthroplasty Patients.

The study aims to understand the existing differences between frail and non-frail subjects who underwent a rehabilitation path after receiving hip or knee arthroplasty surgery.

Applying a Multidisciplinary Intervention for Drug Adequacy in an Intermediate Care Hospital (AMIDA-ICH)

The goal of this clinical trial is to learn if a multi-professional (conducted by geriatricians, clinical pharmacists, nurses) medication revision, centered on patients' goals and characteristics, can improve treatment adequacy in older adults admitted to an intermediate care hospital. The main question it aims to answer is: does this approach reduce the average number of medications taken per patient? Researchers will compare this multi-professional patient-centered revision to the usual standard of care (treatment revision conducted by a clinical pharmacist) to see if the patient-centered revision works in improving treatment adequacy. Participants admitted to an intermediate care hospital will undergo a comprehensive assessment by a geriatrician, and a medication revision (conducted by a multidisciplinary team or a clinical-pharmacist alone). They will also be asked to fulfill some questionnaires on their health status and attitudes. Any possible adverse events to the medications will be recorded at discharge. Participants will be contacted again three months after discharge to check for any readmission or death.

Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients

Frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (OPCAB) surgery is superior to conventional on-pump coronary artery bypass grafting (CABG) surgery. There is an ongoing debate about the benefits and disadvantages of OPCAB surgery and we believe that this remains an important technique for the improvement of coronary surgery. The benefits of CABG surgery in frail patients are still undetermined. The aim of this study is to clarify the potential benefit of OPCAB surgery in pre-frail and frail patients by comparing off-pump versus on-pump CABG in these patients.

Effect of Modified Poco-Poco Exercise to Frailty Stages, Expression of Global DNA Methylation, GDF15 and Lamin A COP

The goal of this clinical trial is to know the effect of multicomponent exercise in frail elderly in community to aging hallmarks. The main question\[s\] it aims to answer are: 1. Do global DNA methylation levels change in elderly people in Bandung after receiving modified poco-poco exercise? 2. Do GDF15 levels change in elderly people in Bandung after they are given modified poco-poco exercise? 3. Do lamin A COP levels change in elderly people in Bandung after they are given modified poco-poco exercise? 4. Does the level of frailty in elderly people in Bandung change after they are given modified poco-poco exercise? Participants will be asked to do flexibility, balance, aerobic and strengthening exercise included in poco-poco modified exercise three times a week for 12 weeks