Clinical Research Directory

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.

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.

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

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 20 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.

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.

Improv Music Therapy for Older Adults

Older adults and their care partners will participate in music therapy sessions for approximately 8 weeks. Before and after the 8 week study period, participants will fill out questionnaires about their mood, stress levels, and emotions. During the music therapy sessions, they may be observed or asked questions about the music therapy sessions.

Virtual Reality-Enhanced Behavioral Activation for Older Adults With Depression

The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive virtual reality (VR) headset to engage in behavioral activation (BA) for older adults diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using VR to enhance BA therapy in a clinical MDD older adult population.

CBT-I in Older African American Adults

Sleep problems, like insomnia, are common in older African Americans. About 25% of older adults in the US have at least 2 symptoms of insomnia, such as having trouble falling asleep, staying asleep, or getting good sleep for a month or more. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a recommended non-pharmacological treatment for insomnia. Unlike medicines that might only help for a short time or have many side effects, CBT-I deals with the root causes of insomnia. It helps people change how they think and act about sleep, leading to better habits and attitudes. This can make sleep better for a long time, even after the treatment is over. While CBT-I is commonly used among adults with insomnia, its benefits among older adults and specifically older African American adults are not well understood. Thus, the current pilot study will investigate the feasibility of CBT-I in older African American adults and establish preliminary evidence for the potential benefit of CBT-I on sleep as well as cognition in this population. For this study, participants will be asked to complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, which collects specific sleep measures such as brain waves and sleep stage timing, and computer-based neuropsychological tests before and after intervention. Study interventions will consist of 8 weekly sleep training sessions via Zoom or a single session of education on strategies to improve sleep quality. Sleep training sessions will include education about strategies to improve sleep quality, changing thought process that contribute to insomnia, training the brain on the optimal sleep environment, and reducing sleep initially to establish a consistent sleep schedule before increasing sleep time. Three months after the post-intervention visit, participants will be asked to come back in for a follow-up evaluation which consists of complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, and computer-based neuropsychological tests.

Modifying the Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department for Telehealth

The goal of this clinical trial is to determine the feasibility of eGAPcare, a telehealth modification of the GAPcare fall prevention intervention, in older adults in a community emergency department. The main questions it aims to answer are: * Can telehealth physical therapy and pharmacy consultations be conducted in a community emergency department? * Does the telehealth modification of GAPcare decrease recurrent falls at 6 months? Participants will * Receive telehealth physical therapy and pharmacy consultation while in the emergency department * Participate in follow-up visits over the phone for 6 months following the initial emergency department visit * Complete study questionnaires delivered by study staff.

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.

Self-Compassion, Self-Efficacy, and Health Outcomes in Older Adults

This cross-sectional observational study aims to examine the relationship between self-compassion, self-efficacy, postural awareness, pain, quality of life, and health-promoting lifestyle behaviors in adults aged 65 years and older. Data will be collected using validated self-report questionnaires administered online. The findings are expected to contribute to a better understanding of psychological factors associated with physical and behavioral health outcomes in older adults.

The Effect of a Passive Hip Exoskeleton on Daily-life Fatigue in Older Adults

This crossover study investigates whether a passive lower-limb exoskeleton (Exoband) can reduce perceived exertion during everyday mobility tasks in older adults. Participants complete the fatigue protocol- a structured sequence of daily challenging tasks (e.g., overground walking, stair and slope walking, obstacle avoidance)-once with the Exoband and once without it, in randomized order and separated by a one-week washout period. During each session, distance covered until fatigue, rate of perceived exertion, physiological and gait parameters are recorded. The aim is to determine whether exoskeleton assistance enhances mobility performance and reduces functional fatigue across older adults.

Healthcare Services for Older People Who Have Fallen With Potential Head Injury

Every year, one in three older people (\>65 years old) experience a fall. Older people may have long-term health conditions and take medications that can increase their risk of bleeding (blood thinners). The UK national guidelines recommend that older people who are on blood thinning medications should have a CT head scan considered due to concerns of a brain bleed if they have hit their head after a fall. Many older people are therefore brought into hospital for assessment. However, the risk of bleeding in the brain is very low especially if older people do not have any symptoms such as loss of consciousness, weakness, headaches or vomiting. Some people could experience long waits in the emergency department or end up being admitted to hospital unnecessarily. This could worsen mobility, cause confusion, pressure sores or infections in older people. More importantly, older people should have a comprehensive falls assessment to reduce their risk of future falls and have their medications reviewed after experiencing a fall. These assessments could potentially take place in their own homes if they prefer, rather than in hospital. Yet, current healthcare services outside the hospital setting may not be set up to manage an older person after fall. Using an online survey, the investigators want to understand how current healthcare services in the Hampshire and Isle of Wight (HIOW) region work to look after older people who have had a fall. The study will focus particularly on older people taking blood thinning medications who may have a head injury but do not have any symptoms. The investigators will ask NHS workers what their role is, where they work and what they do when assessing an older person who has fallen if there is a concern about head injury. The survey will also ask participants to describe what challenges they may face, and if they have any suggestions to improve the care for older people. This study will help the investigators understand what services are available in our current healthcare system for older people on blood thinning medications who have fallen and may have a head injury. The investigators hope that the results will help improve how healthcare services can work together with older people and their closed ones to provide care based on what matters most to them in their preferred place of care. This could reduce unnecessary use of emergency services and hospital admissions for older people.

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.

Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT

The goal of this clinical trial is to learn if I-CONNECT (Integrated Care for Older Adults with Major Depression and Physical Multimorbidity) can improve the health and well-being of older adults with depression or bipolar disorder and at least two chronic physical conditions, such as diabetes or high blood pressure. It will also study if the care model improves how people experience their care, lowers treatment burden, and how well the program is delivered. Researchers will compare two groups: I-CONNECT group: participants receive care coordination, a personalized care plan, medication review, shared decision-making support, and regular follow-up from a care coordinator working with their GP, psychiatrist, pharmacist, and specialists. Usual care group: participants continue with their normal healthcare from their GP and psychiatrist. Participants will: Receive either I-CONNECT or usual care, depending on their group Complete questionnaires about their mood, quality of life, and care experience Have their healthcare use (emergency visits and hospitalizations) tracked during the study

Effect of Health Promotion Model-Based Oculomotor Exercise Program on Sleep Quality in Older Adults

The goal of this clinical trial is to investigate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home. The main questions it aims to answer are: Does the Health Promotion Model-based oculomotor exercise program improve sleep quality in older adults living in a nursing home? Does participation in the program enhance self-efficacy and promote better health behaviors related to sleep?

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.

Pose Estimation and Inertial Measurement Unit Systems for Gait Analysis in Older Adults

-This observational study aims to compare gait analysis performed using pose estimation algorithms with inertial measurement unit (IMU)-based gait analysis in older adults. Additionally, it aims to determine the reliability of gait analysis using pose estimation algorithms in this population. The main questions it aims to answer are: 1. Are gait analyses using pose estimation algorithms consistent with those performed using an inertial measurement unit-based system in older adults? 2. Are gait analyses using pose estimation algorithms reliable in older adults? Participants will take part in two measurement sessions. In the first session, they will be evaluated for inclusion criteria and general health status, and will complete gait analysis using both G-Walk (BTS Bioengineering) IMU sensors and a standard video camera simultaneously. In the second session, scheduled 1-3 days later, participants will perform only the 4-meter walking test, which will be recorded by video for pose estimation analysis.

Incidence and Factors of Functional Decline After Emergency Department Discharge in Older Adults With Falls

The goal of this observational study is to learn about changes in activities of daily living (ADL) in older adults after being discharged from the emergency department (ED) following a fall. The main questions this study aims to answer are: How often do older adults experience a decline in their ability to perform daily activities after being discharged from the ED for a fall? What health or lifestyle factors (such as frailty, medications, physical activity, or fear of falling) are related to this decline? Participants will be 65 years or older, admitted to the ED for a simple fall, and discharged without hospitalization. At the time of their ED visit, participants will be asked questions about their health, medications, activity level, and daily functioning. They will then be contacted online or by phone at 7 days and 30 days after discharge to answer follow-up questions. This study will help identify how common functional decline is after falls in older adults discharged from the ED, and which factors may predict higher risk. These findings could help improve follow-up care and prevention strategies for older patients.

Digital Home-Based Physical Activity Promotion for Older Adults After Total Hip Arthroplasty

The goal of this clinical trial is to evaluate the efficacy of a 12-week digital home-based intervention program, consisting of a tablet-based exercise program with or without personal coaching, to promote physical activity (PA) in older adults after total hip arthroplasty (THA). The main question it aims to answer is: • Does the combination of the digital exercise program and personal coaching lead to higher PA six months after THA compared to usual care among older adults? Secondary questions are: * Does the digital exercise program alone lead to higher PA compared to usual care? * Does the digital exercise program combined with personal coaching lead to higher PA compared to the exercise program alone? Participants' PA will be objectively measured with a body-fixed sensor at 1 week before THA (T1), 6 weeks after THA (T2), and 6 months (i.e. after THA (T3). After the postoperative assessment at T2, participants will be randomly assigned to one of three groups: * 12-week tablet-based exercise program at home with virtual personal coaching for physical activity promotion * 12-week tablet-based exercise program at home * Usual care (control group, no additional intervention)