Clinical Research Directory

Itaca App vs. Usual Care for Medication Adherence in Older Adults on Polypharmacy

The goal of this clinical trial is to learn if the use of a mobile app called Itaca improves medication adherence in older adults (aged ≥65) in a home care setting. It will also assess the impact of the app on patient engagement, patient activation, quality of life, and the app's usability in the intervention group. The main question it aims to answer is: * Does the use of the Itaca mobile application improve medication adherence among older adults in the home care setting compared with usual care? * Does the use of the Itaca mobile application improve patient engagement, patient activation, and quality of life among older adults in the home care setting compared with usual care? Researchers will compare usual care to see if the intervention using the Itaca mobile app is more effective in improving medication adherence. Participants will: * In the intervention group, use the Itaca app for 3 months * In the intervention group, receive monthly phone calls to support adherence to the study protocol, monitor app use, and address any barriers * In the intervention group, complete the usability scale at the end of the 3-month intervention period * In both the intervention and control groups, complete the questionnaires at enrollment and after 3 months, at the end of the intervention period

A Pilot Randomized Controlled Trial of a Social Network Intervention

This is a pilot randomized controlled trial to assess the feasibility, acceptability, appropriateness, and structure of the SONATA intervention. In addition, it will assess the preliminary efficacy of SONATA compared to enhanced usual care among 70 older adults with advanced cancer.

RESISTANCE TRAINING AND CAPILLARIZATION - ROLE ON THE ANABOLIC RESPONSE IN OLDER ADULTS

The goal of this clinical trial is to learn how muscle capillaries influence the response to resistance exercise training in older adults. The study will include older men and women who may experience age-related declines in muscle mass and function. The main questions it aims to answer are: * Does baseline muscle capillarization influence the increase in muscle size and function following resistance exercise training? * Can resistance exercise stimulate the formation of new capillaries in older adults with lower baseline capillarization, and how is this related to muscle growth? Participants will: * Undergo assessments of muscle structure, capillarization, and physical function before and after the intervention. * Participate in a supervised resistance exercise training program. * Provide muscle samples and other physiological measurements to evaluate changes in muscle growth and blood vessel formation. Researchers will analyze the relationship between baseline muscle capillarization, exercise-induced angiogenesis, and improvements in muscle mass and function to better understand why some older adults respond more effectively to resistance exercise than others.

Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.

This study investigates a new training method designed to help older adults preserve their muscle strength during hospitalization. When older adults are admitted to the hospital and spend long periods in bed, their muscles can weaken very quickly. This condition is known as hospital-associated disability (HAD), and it can lead to longer hospital stays, reduced independence, and an increased risk of complications or even death. Conventional strength training with heavy weights is often too demanding or unsafe for frail patients, especially just after surgery or illness. As a safer alternative, this study combines light muscle exercises with a medically validated technique called blood flow restriction (BFR), which gently reduces blood flow to the leg to boost the effects of light exercises. To make training more engaging and personalized, the GHOSTLY+ system was developed. This system consists of a game played on a tablet that responds to muscle activity through sensors placed on the skin. While playing, patients perform isometric muscle contractions (exercises where the muscles tighten without moving the joint) that help to maintain and rebuild strength. The system was carefully designed in collaboration with patients and therapists, and it has already been tested in a smaller pilot study at UZ Brussel. The current study is a multicenter randomized controlled trial, taking place at UZ Brussel, UZ Antwerpen, and UZ Leuven. A total of 120 patients aged 65 or older will be recruited, all of whom are hospitalized and are unable to bear weight or transfer (e.g., from lying to seated position). Participants will be randomly assigned to one of two groups. One group receives standard physiotherapy. The other group receives standard therapy plus the GHOSTLY+ training program. Those in the GHOSTLY+ group will train at least five times per week for two weeks, or until discharge from the hospital. Each training session lasts approximately 30 minutes and involves three sets of 12 muscle contractions, guided by the game. The difficulty is adapted to the individual's muscle strength, which is measured at the beginning of the training using a built-in calibration protocol. During the session, a smart cuff is applied to the upper leg to partially restrict blood flow - a technique shown to safely enhance muscle adaptation. The cuff is inflated to 50% of the individual's arterial occlusion pressure and deflated after the session ends. Before beginning, participants receive a short training session with a physiotherapist. Our pilot study (Debeuf et al., 2025) shows that most patients can use the system independently after about one hour of instruction. Measurements and evaluations take place at three timepoints: before starting the training, after one week, and again at discharge. The main goal is to assess leg muscle strength, which will be measured using a handheld device called a dynamometer. In addition, researchers will collect information on: * Muscle mass, via ultrasound of the thigh muscle * Functional capacity, using a 30-second sit-to-stand test and a walking scale (Functional Ambulation Category) * An index of independence in activities of daily living (Katz scale) * Cognitive functioning, using the Mini-Mental State Examination (MMSE) * Time spent bedridden and total length of hospital stay * Therapy adherence and user experience, via usage data and questionnaires * Muscle activity signals, such as fatigue, recorded during gameplay * Implementation outcomes (collected via surveys, interview, site logbooks) The study will also assess how easily the GHOSTLY+ system can be implemented in real hospital environments. This includes evaluations of user satisfaction, therapist feedback, and how consistently the system is used across hospital settings. Information will be gathered through structured interviews, surveys, and data logs from the app. These insights are crucial to understanding whether GHOSTLY+ can be broadly adopted in other hospitals in the future. Blood flow restriction training is considered very safe when applied correctly and is already used in rehabilitation clinics and sports medicine worldwide. Over 300,000 sessions have been conducted internationally, with a very low rate of complications. Minor discomfort, such as temporary tightness or muscle fatigue, may occur, but the risk of serious side effects is extremely small. By participating in this study, patients may benefit from improved muscle strength, reduced time spent in bed, and greater physical independence at discharge. The study also contributes to the development of more effective and enjoyable rehabilitation methods for older adults in hospitals.

Feasibility of Virtual Reality-assisted Ergometer Cycling in Addition to Regular Rehabilitation During Municipality-based Inpatient Rehabilitation Care

VR-C-REHAB is a single-group pilot and feasibility study examining the practicality of implementing virtual-reality-assisted ergometer cycling as an adjunct to usual municipal inpatient rehabilitation for older adults (≥65 years). Many individuals admitted to temporary inpatient care present with low physical activity levels and fluctuating motivation, reducing the achievable exercise dose. Virtual reality may enhance engagement, enjoyment, and adherence, but its feasibility in this setting must be evaluated before conducting a future effect trial. The primary objective is to determine whether participants can achieve an adequate exercise dose, defined as the proportion of completed VR-cycling sessions out of those offered (target: ≥75%). Secondary feasibility outcomes include recruitment rate, safety and acceptability, and total cycling time. Exploratory outcomes include change in the 10-Meter Walk Test and session-level motivation (0-10). The intervention consists of 15 minutes of VR-assisted cycling, three times weekly for up to four weeks, delivered alongside standard rehabilitation. Data are collected at baseline, during each session, and at completion. Analyses are descriptive, focusing on the precision of feasibility estimates. Progression criteria (Go/Amend/Stop) are based on adherence, recruitment, and safety. The results will inform the design and implementation of a subsequent controlled study.

Reliability and Validity of Tele-Assessment for Functional Performance in Older vs. Younger Adults

This cross-sectional, comparative study aims to examine the intra-rater reliability, validity, and feasibility of tele-assessment versions of three functional mobility tests-the Timed Up and Go (TUG), 30-second Sit-to-Stand (30sSTS), and Gait Speed Test (GST)-in community-dwelling older adults (≥65 years). To provide a comparative perspective, the same assessments will also be administered to a younger, healthy control group (18-44 years). The study seeks to determine whether tele-assessment can serve as a robust and practical alternative to in-person testing, thereby enhancing accessibility and ensuring high-quality functional evaluation in geriatric populations.

Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

In Norway, more than 11,000 patients undergo percutaneous coronary intervention (PCI) annually. However, a very recent study utilizing registry data show a national average of cardiac rehabilitation (CR) participation of only 14%, despite its proven beneficial effects on readmissions, physical capacity, psychological distress, self-management, and quality of life. CR is strongly recommended in European guidelines. However, uptake is low and is not systematically identifying those in most need of CR. The primary objective of eCardiacRehab is to meet rehabilitation needs of large patient populations regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based eCardiacRehab programme. eCardiacRehab address patient- and system level challenges in order to increase access to CR. The investigators give particular attention to older patients, women, and those with comorbidities or mental health challenges. Aspects related to continuity of care between specialist and primary care services, health literacy, adherence to treatment, cost effectiveness and ethics are investigated. The investigators will 1) continue to develop the programme with patients, general practitioners, healthcare experts from both specialist and primary care services, and technology developers, 2) develop treatment modules, 3) establish information and communication infrastructure, 4) evaluate the process and efficacy of treatment modules, 5) ensure knowledge development and transfer of competence to the municipalities, and 6) contribute to fulfil the innovation potential for health service and industry partners. eCardiacRehab has the potential to improve interaction and collaboration between primary and secondary care, modernise and digitalise work processes, and develop more coherent and tailored patient pathways. The vision of the home-based eCardiacRehab is to make CR available to all.

eCardiacRehab - a Hybrid Patient-Centered eHealth Programme

The overall aim of eCardiacRehab trial is to meet rehabilitation needs of patients with coronary artery disease (CAD) regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based hybrid programme. eCardiacRehab address patient- and system level challenges to increase access to cardiac rehabilitation (CR). We give particular attention to older patients, women, and those with comorbidities or mental health challenges. The vision of the hybrid home-based eCardiacRehab programme is to make CR available to all. eCardiacRehab is a prospective, multicentre randomized open-label blinded end point evaluation (PROBE) trial. The primary endpoint is a hierarchical composite endpoint using a win-ratio framework combining cardiovascular (CV) death, unplanned contacts to the Emergency Department (ED) for observation or admission (\>24 hours) for CV disease, and quality of life. Inclusion criteria are adult Scandinavian speaking patients (≥ 18 years) who have a Norwegian national identification number, with CAD treated with Percutaneous Coronary Intervention (PCI), are living at home, and have internet available to them and providing signed informed consent. Exclusion criteria are patients with severe aortic stenosis, severe arrhythmias, expected lifetime less than one year as determined by study personnel, otherwise clinically unstable, not fully revascularized, awaits PCI or coronary artery bypass graft operation (CABG) or inability to comply with the study protocol due to any physical disability, somatic disease, cognitive impairment or mental health challenges as determined by study personnel.

Promoting Walking Among Older Adults Through Affective Communication and Step-Monitoring

Physical inactivity increases substantially after age 60 and represents a major public health challenge in older adults, as it is linked to increased risk of functional and cognitive decline and aging problems. Walking is one of the most accessible and recommended forms of light-to-moderate physical activity for this population. However, promoting sustained engagement in walking remains difficult, as traditional informational approaches often fail to activate personally meaningful motivations. This study tests whether persuasive affective messages can promote walking by leveraging self-continuity, meaning the use of autobiographical memory to maintain the sense of being the same person across time and contexts, connecting the past, present, and future self. Self-continuity is associated with psychological resources such as self-esteem, self-efficacy, and a sense of meaning in life. The affective mechanism that sustains self-continuity is nostalgia: both promote emotional and behavioral regulation and support goal achievement. Building on this framework, the present trial examines whether activating feelings of self-continuity and positive nostalgic memories can strengthen older adults' motivation to engage in walking behavior. In addition, the study investigates whether combining self-continuity messaging with a self-regulation strategy (daily step monitoring) enhances intervention effectiveness. Self-monitoring is a well-established behavioral technique that supports goal pursuit by increasing awareness and feedback. Using a 4-arm randomised controlled factorial design, the study compares the effects of self-continuity messages, step-monitoring reminders, their combination, and an active control condition on walking behaviour and its psychological determinants. A national sample of 1,000 Italian adults aged 65-74, recruited through a certified panel provider (Ipsos) and balanced for age, gender, and geographic region, will be randomly assigned to one of the four conditions. All participants will receive one message per day through a mobile application over a 14-day period. Participants in the step-monitoring conditions will also be asked to track and report their daily step count using a pedometer application. Behavioral, psychological, and process measures will be collected at baseline, post-intervention, and follow-up. The study therefore aims to provide experimental evidence on the role of self-continuity as a motivational driver of health behaviour change, and to clarify whether combining affective and self-regulatory strategies enhances intervention effectiveness in older adults.

ROLE OF DUAL-TASK COST IN PREDICTING FALL RISK AMONG OLDER ADULTS RECEIVING INSTITUTIONAL CARE

There is a need for studies that examine the role of dual-task cost in predicting fall risk among older adults receiving institutional care and that develop classification models that can be used in clinical practice. The planned study aims to determine the discriminative ability of dual-task cost in identifying fall risk and to establish clinically meaningful cutoff values. In this respect, the study will both contribute to a more sensitive assessment of fall risk and provide a scientific basis for a low-cost, practical, and applicable screening approach.

Physical and Cognitive Aging Study in Older Adults

Hispanic Americans are the fastest growing older adult group in the United States, disproportionally increasing the risk of an Alzheimer's disease and related dementias diagnosis. Efforts to reduce this risk and mitigate the related cognitive/physical declines are critical. The aim of this study is to assess the feasibility of enrolling older adults into an aging trajectory cohort, while generating preliminary data on associations of physical and cognitive aging trajectories. Our secondary objective is to generate preliminary data on the association of standard measures of physical activity and physical function with cognitive status. This study fits within our longitudinal research goal to reduce dementia incidence by understanding the mechanisms that drive the cognitive-physical aging trajectory.

How Video Game Therapy Affects Thinking and Emotions in Older Adults With Cognitive Impairment

Golden Gamers Go is running a study together with Rey Juan Carlos University to better understand how videogames can help older adults, especially those with memory problems or cognitive decline. The study takes place in real care settings, such as day centers, and involves around 45 older participants. Over two months (with a possible follow-up period), participants take part in two to three sessions per week using video games on PlayStation. These are not special "health games," but popular, commercial video games that have been carefully selected and adapted to be easy to use, enjoyable, and meaningful for older adults. The goal is to see whether playing these games can help improve thinking abilities and also how participants feel during the activity - for example, if they are more engaged, motivated, or emotionally positive. This study builds on previous experience where this approach has already shown promising results in increasing participation, motivation, and overall wellbeing. By carrying out this research, Golden Gamers Go aim to better understand how meaningful and enjoyable activities like videogames can support healthier and more active aging.

Zinc Supplementation and Infections in Older Medical Patients

The goal of this clinical trial is to learn about the effect of zinc supplementation once daily for 12 months in older acute medical patients. The main question it aims to answer is: • Can daily zinc supplementation for 12 months increase Days Alive and Out of Hospital (DAOH)? Researchers will compare zinc supplementation to a control group, a group who do not receive zinc supplementation, to see if zinc supplementation can increase Days Alive and Out of Hospital, reduce antibiotic use, readmissions and mortality. Participants will take 22 mg zinc supplementation once daily for 12 months or not. The researchers will draw data on readmissions, antibiotic use and mortality during the 12 months follow-up period.

Optimizing Care Transition Process for Older Colorectal Surgery Patients

The goal of this study to test if a care transition intervention designed for older colorectal surgery patients would improve outcomes after discharge. It will assess the feasibility of the intervention.

SCT-Based Health Promotion in Older Adults

This study will be conducted to compare the effects of Peer- and Nurse-Led Health Protection and Promotion Training Programs Based on Social Cognitive Theory (SCT) on the health behaviors of older adults. This research will be carried out in two stages as a mixed-methods study with an embedded mixed-method design. The first stage has been planned as a parallel two-arm non-randomized experimental study. This stage will be conducted between October and December 2025 in two separate elderly homes where older adults are densely located in the Muratpaşa district of Antalya province. The sample size has been calculated as 108 older adults (Intervention-1 Peer Leadership: 54, Intervention-2 Nurse Leadership: 54). In the Intervention-1 group, the intervention will be implemented for 12 weeks through the Health Protection and Promotion Training Program Based on SCT under peer leadership, and the same interventions will be carried out in the Intervention-2 group under nurse leadership. Outcomes will be measured before the intervention and 12 weeks after the intervention using the Elderly Health Promotion Scale, Health Protection and Promotion Behavior Checklist, General Self-Efficacy Scale, and Health Seeking Behavior Scale. In the second stage, in order to evaluate the intervention process and experiences multidimensionally, it is aimed to deeply understand the experiences of older adults receiving peer-led intervention, older adults receiving nurse-led intervention, and peer leaders by using multiple data sources within the framework of qualitative research and a phenomenological approach. In the qualitative phase, the data will be collected based on the maximum variation sampling method through face-to-face in-depth individual interviews using semi-structured interview forms in the workshops of both elderly homes in January 2026.

Genius PillBox Study

The purpose of this study is to pilot test the how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence.

Respiratory Exercises in Frail Elderly COPD Patients

Purpose: This study evaluated the impact of a structured intervention on frailty, lung function, physical capacity, and dyspnea in elderly COPD patients. COPD, common in older adults, often coexists with frailty, which worsens health outcomes. While pulmonary rehabilitation improves function, its effect on frailty remains unclear. Procedures: A total of 66 patients with a confirmed diagnosis of COPD were randomly allocated into two equal groups: an intervention group (n=33) and a control group (n=33). Participants in the intervention group completed a six-week pulmonary rehabilitation program. Both baseline and post-intervention evaluations comprised spirometric measurements (FVC, FEV1, FEV1/FVC ratio, FEF25-75, and PEF), the Edmonton Frailty Scale (EFS), the six-minute walk test (6MWT), oxygen saturation levels, and assessments of dyspnea severity. Results: Significant improvements were observed in the intervention group in FVC, FEV1, FEV1/FVC, and PEF (p\<0.05). Total EFS scores and subdimensions such as mood, general health, and cognitive status also improved significantly (p\<0.05). Additionally, the intervention group showed increased 6MWT distance, higher oxygen saturation, and reduced dyspnea scores post-intervention (p\<0.05), with minimal changes in the control group. Conclusion: The findings suggest that pulmonary rehabilitation not only enhances pulmonary function and exercise capacity but also reduces frailty severity in elderly COPD patients. Integrating frailty-focused strategies into routine COPD management may improve outcomes and quality of life in this population.

Predictors of Climate Change Health Literacy in Older Individuals

The aim of this study is to identify predictors of climate change health literacy in older adults.

Technology-based Hand Rehabilitation in Older People

Because hand and cognitive functions decline in the elderly, intervention programs addressing these problems are necessary. In recent years, creating rehabilitation programs using technology has gained popularity. The aim of this study is to examine the effects of technology-based rehabilitation using LMC (Light Mood Enhancer) and dual upper extremity tasks on joint position sense, grip strength, functionality, and executive functions in elderly individuals; and to compare these effects with those of an exercise program performed solely with an LMC device and a control group consisting of a hand rehabilitation program performed with a physiotherapist. The research is a randomized controlled trial and will consist of 3 groups. After randomization, individuals' joint position sense, gross and fine grip strength, functionality, and executive functions will be evaluated. Evaluations will be performed twice, at the beginning and end of the 8-week program.

Effects of Breathing Exercises on Cognition in Older Adults

The goal of this interventional clinical trial is to investigate the effects of breathing exercises added to balance training on cognitive function in individuals aged 65 years and older. The main questions it aims to answer are: Do breathing exercises affect cognition? Do different breathing exercises affect cognition in different ways? Researchers will administer two different breathing protocols and evaluate cognition before and after each protocol. Participants will take part in an 8-week program consisting of sessions that include 30 minutes of balance-based exercises and 15 minutes of breathing exercises. Sessions will be held twice weekly under the supervision of a physical therapist.

The Effect of Virtual Reality in Older Adults

This research will be conducted to examine the effects of virtual reality on sleep quality and comfort in older adults. This research will be conducted as a single-blind, randomized controlled experimental study with a pre-test-post-test design, involving application and control groups, to examine the effect of virtual reality on sleep quality and comfort in elderly adult patients hospitalized in the internal medicine and surgical clinics of Kars Harakani State Hospital between December 15, 2025, and December 31, 2026. To inform older adults, and after obtaining informed consent, the study will be administered using a "Senior Adult Descriptive Information Form" containing demographic information about older adults, the Standardized Mini Mental Test which assesses the cognitive level of older adults, and a "Senior Adult Monitoring Form" to track any potential side effects of the intervention. The Senior Adult Descriptive Information Form, the Richards-Campbell Sleep Scale (RCSQ), and the VAS Comfort Scale (VCS) will be used to collect data for the study. Data will be collected from elderly adults hospitalized in the internal medicine and surgical clinics of Kars Harakani State Hospital who meet the research criteria. They will be shown 360-degree video images (Chitra and Eremita 2023; Eremita and Chitra 2024) for 20 minutes each night during their hospitalization hours using VR Shinecon virtual reality glasses.

Population Health Approach to Optimizing Medications in Older Adults

This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.

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

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

Cognition in Older Adults With Cancer Receiving Systemic Anti-Cancer Therapy

The majority of cancer diagnoses occur in adults age 65 years and over. This population is also rapidly expanding. There is a growing need for increased understanding about the potential impact of various newer therapies on common geriatric impairments in this group. The aim of this study is to examine how feasible it is to carry out a study of cognitive function in older adults (age 65+) who are newly commencing anti-cancer treatments, specifically 'immune checkpoint inhibitor' therapy, over time. Participants in the study undergo four tests of memory and concentration every six weeks for a six month period. Additionally, the researcher will gather information about the participants' non-cancer therapy medications, physical and psychological symptoms, day to day functioning and any changes to these factors over time. The purpose of the study is to examine a) recruitment, retention and engagement of participants to study procedures; b) to gather preliminary information about cognitive function in older adults commencing immune checkpoint inhibitor treatments and potential associations with cognitive decline over time.