Clinical Research Directory

Feasibility of High-intensity Functional Exercise With Simultaneous Cognitive Challenge for Older People With Falls Risk

This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims: 1. To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences. 2. To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences. The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.

Home-Based Exercise Program After Community Balance Training for Parkinson's Disease

This study tested whether a home-based exercise program helps older adults with Parkinson's disease keep the improvements they gain from a community balance program. Participants lived in small towns and rural communities in Oklahoma, where access to movement disorder specialists is limited. All participants first took part in a three-month community-based recreational therapy balance program. At the end of those three months, participants were randomly assigned to one of two groups. One group continued with a home-based program for twelve weeks, which included an exercise manual, instructional videos, and a weekly telephone call from a researcher. The other group received general wellness guidance without follow-up contact. Participants were assessed three times: before the community program began, at three months, and at six months. The assessments measured walking speed, stride length, and cadence; postural stability; concern about falling; anxiety and depression; social connectedness; and quality of life. The purpose of the study was to learn whether continued support at home helps people hold onto the gains they make in a community program, and how quickly those gains are lost without that support.

Optimal Intensity of Reactive Balance Training for Healthy Older Adults

Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.

Comparative Effects of Reactive Balance Training and Task-Oriented Training on Postural Stability in Patients With Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) is a common complication of prolonged hyperglycemia that damages peripheral nerves, leading to impaired sensory function, increased fall risk, and reduced quality of life. Balance training has shown promising effects in improving postural stability and reducing fall risk in individuals with DPN by engaging visual, vestibular, and proprioceptive systems and promoting central nervous system adaptation. This randomized controlled trial aims to compare the effects of Reactive Balance Training (RBT) and Task-Oriented Training (TOT) on postural stability in patients with DPN. The study will be a single-blinded, two-group randomized controlled trial conducted over one year at Foundation University College of Physical Therapy. A sample of 36 participants will be recruited through convenience sampling and randomly allocated into two groups using the coin-toss method. Ethical approval will be obtained from the FUSH ERC, and written informed consent will be obtained after explaining the study procedures, risks, and benefits. Postural stability will be assessed using the Posture Assessment Checklist, Mini-BESTest, Functional Reach Test (FRT), and Timed Up and Go (TUG). Group A will receive RBT, while Group B will receive TOT. Each session will last 30-40 minutes, including a 5-7-minute warm-up, 20-30 minutes of group-specific intervention, and a 5-minute cool-down. Participants will receive 60-second rest intervals after every three sets or 8-10 repetitions. The intervention will continue for six weeks, with three sessions per week, totaling 18 sessions. Assessments will be conducted at baseline, at week 3, and post-intervention at week 6 using the same outcome measures.

Polymodal Fall Prediction in Healthy Older Adults: Clinical, Laboratory, and Blood-Based Biomarkers

The goal of this observational study is to identify clinical, laboratory, and biological markers associated with past (and future falls) in healthy older adults aged 65 years and over. The main question it aims to answer is: Which clinical, functional, laboratory, and blood-based markers distinguish older adults who have fallen at least once during the previous 12 months from those who have not? Researchers will compare older adults with a history of falls with similar older adults without a history of falls. One hundred healthy older adults aged 65 and over, including both fallers and non-fallers, will be recruited for the study. Participants will complete questionnaires and undergo cognitive and physical tests, physical activity and sleep monitoring, gait, balance, muscle, sensory and vestibular assessments, brain and muscle imaging, and blood sampling. Blood samples will be used to study proteins and genetic variants that may be associated with falls. Participants will then be followed for one year using a smartphone-based application to report falls. The study is based on the hypothesis that a history of falling in an otherwise healthy older adult may be associated with subtle clinical, functional, and biological differences compared with a similar older adult without a history of falls. The findings may support the future development of more accurate and scalable tools for early fall-risk detection and targeted fall-prevention strategies. No direct therapeutic benefit is expected from participation.

Pragmatic Trial to Increase Quality of Care in State Veterans Homes

Background: State Veterans Home nursing homes (SVHs) care for 51% of all Veterans receiving VA-funded nursing home care. SVHs cost VA $1.2 billion yearly in per diem payments. This critical system provides care to a population of over 20,000 vulnerable Veterans annually but has been little researched and is in urgent need of attention. In some SVHs, the COVID-19 pandemic has resulted in large numbers of preventable illnesses, hospitalizations, and even deaths. Congress, the Government Accountability Office, and the Secretary have all called for greater VA involvement in this system that lacks a national quality improvement infrastructure and lags behind VA on many quality measures, including falls. This study addresses SVHs' need to reduce high fall rates-55% of residents experience at least one fall per quarter-by implementing an effective, evidence-based program known as LOCK. In LOCK, staff (1) "Learn from bright spots" (focus on evidence of positive change); (2) "Observe" (collect data through systematic observation); (3) "Collaborate in huddles" (conduct frontline staff huddles); and (4) "Keep it bite-size" (limit activities to 5-15 minutes). The program avoids reliance on existing quality improvement infrastructures, can be easily integrated into frontline staff routines, and has demonstrated success in improving clinical outcomes, including reductions in falls. Significance: This study provides the following. (1) Timely, evidence-based research support to improve care for SVHs' vulnerable population of aging Veterans. (2) Explicit integration of frontline staff expertise, ensuring interventions are practicable and successful. (3) Direct alignment with high-reliability principles-such as sensitivity to operations and deference to expertise-helping extend VA's high-reliability focus to SVHs. Innovation and Impact: This study contributes the following. (1) Advances the science of how to intervene in settings that do not have a strong, centralized quality improvement focus through rigorous investigation of how and why an intervention works in SVHs. (2) Investigates sustainment of the investigators' intervention-the extent to which it becomes part of usual care-for up to 12 months after completion of each step of the investigators' wedge-based design. (3) Provides timely, systematic investigation of a new area for VA research, gathering information on VA researcher-SVH partnerships to support future collaborations. Specific Aims: Aim 1: Investigate the effectiveness of the LOCK program at improving the investigators' primary outcome of any resident fall. This study will also investigate other resident clinical outcomes (mobility, medication changes, restraint and alarm use) and work-process outcomes for staff (job satisfaction, work engagement, burnout). This study will use both primary and secondary data collection. Aim 2: Evaluate the LOCK program's implementation. This study will use the replicating effective programs framework and multi-modal implementation facilitation strategies to implement the program. This study will use mixed methods to evaluate the program's reach, adoption, and implementation. Aim 3: Assess the extent of program sustainment. Mixed methods will enable examination of intervention sustainment at 3, 6, and 12 months post intervention and sustainment variability among sites. Methodology: This is a 4-year hybrid (Type 2) effectiveness-implementation study. It uses a pragmatic stepped-wedge randomized trial design and employs relational coordination theory and the RE-AIM framework to guide implementation and evaluation. Next Steps: This study (1) directly improves care for aging Veterans, (2) advances understanding of how to intervene in settings lacking quality improvement infrastructure, and (3) contributes knowledge about intervention sustainment. This study also addresses VA's Research Lifecycle stages of (a) scale up and spread and (b) sustainment. Findings may help improve care in other settings (e.g., inpatient mental health and domiciliary programs).

The Effects of Light-Targeted Balance Training on Balance, Functional Performance, and Fear of Falling in Individuals With a History of Falls

In recent years, exercise programs based on visual stimuli have been reported to improve balance and motor control . However, studies investigating the effects of light-targeted balance training on balance, functional performance, and fear of falling in individuals with a history of falls are limited. The aim of this study is to determine the effects of light-targeted balance training on balance, functional performance, and fear of falling in individuals with a history of falls. In addition, the study aims to investigate whether this training method provides additional benefits compared with traditional balance training. The findings of this study are expected to contribute to the development of rehabilitation programs aimed at preventing falls.

Land vs. Water Exercises on Performance and Swimming Behavior in Older Adults

This study aims to investigate the effects of an 8-week combined land and aquatic exercise program (conducted 3 days per week) on physical performance, recreational swimming behaviors, and water-related risk perceptions in older adults. Physical performance is evaluated using handgrip strength and the 30-second chair sit-up test (30CST), while swimming behaviors and water-related risk perceptions are assessed via structured questionnaires.

Multicomponent Versus Balance Exercise for Older Adults With Recurrent Falls

To compare the short-term effects and 6-month durability of supervised multicomponent exercise, balance exercise alone, and fall-prevention education on balance, strength, walking performance, and health-related quality of life in older adults with recurrent falls.

tDCS in Elderly Fallers Study

The objective of this study is to determine if a four-week, 20-session intervention of transcranial direct current stimulation (tDCS), as compared to sham intervention, improves dual task standing and walking performance (Aim 1), as well as other physical (Aim 2) and cognitive (Aim 3) factors on the causal pathway to falls, in older adults who report two or more falls within the past year and fear of falling again in the future, yet who do not have any acute or over neurological or musculoskeletal condition. Primary endpoints will include the "dual task" costs to gait speed when walking and postural sway speed when standing, as induced by performing a serial subtraction cognitive task (i.e., \[(speeddual task - speedsingle task) / speedsingle task) X 100\] (Aim 1), the Short Physical Performance Battery (Aim 2), and the Trail Making Test (Part B minus Part A) (AIM 3). Secondary endpoints will include the dual task cost to serial subtraction performance, additional gait and balance outcomes derived from the dual task paradigm, the Timed Up-and-Go, fear of falling, habitual physical activity, and performance within a battery of neuropsychological tests focused on global cognitive function, attention, verbal fluency and memory.

Training Improves Balance Control

The purpose of this study was to evaluate the effect of a group-based functional and specific balance training program on balance function in healthy older adults. It is commonly considered difficult to improve balance function in healthy older adults. The program included dual-task exercises; physical training exercises and a cognitive task (e.g. reading or reciting a story) performed simultaneously, as well as perturbation exercises, where balance is challenged in unexpected ways. The investigators hypothesized that following the proposed training, older adults would improve their speed of taking a step in both single and dual task conditions, refine their ability to control balance when standing still and improve their self-reported physical function.

Impact of Primary Nursing on Nursing-sensitive Outcomes in Inpatients Units: a Multicentre Pre-Post Study

The aim of this quasi-experimental before-after study is to evaluate whether the implementation of the Primary Nursing (PN) pattern of care improves nursing-sensitive outcomes in adult inpatients and nurse-related outcomes across hospital wards in Northern Italy. The main questions it aims to answer are: 1. What is the impact of the PN on inpatients' nursing-sensitive outcomes, including healthcare-associated infections, falls, pressure injuries, functional status, and patient satisfaction? 2. What is the impact of the PN on nurse-related outcomes, including burnout, missed nursing care, job satisfaction, and intention to leave? This study follows a multicentre, uncontrolled before-after design: in the pre-intervention phase, wards operated according to their existing nursing care models (functional or team nursing); this was followed by the implementation of the PN across all participating wards. The PN assigns each patient to a single reference nurse who is responsible for planning, delivering, and evaluating nursing care throughout the entire hospital stay. In the primary nurse's absence, an associate nurse ensures continuity by following the individualised care plan.

Tai Chi Intervention for Balance Function in Older Adults: Predictive and Modifying Roles of Circadian Age

This study investigates the effects of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Participants are randomly assigned to either a Tai Chi exercise group or a health education control group. The primary outcome is balance function measured by the Berg Balance Scale. Secondary outcomes include physical function, psychological well-being, cognitive function, and sleep quality. The study also explores the predictive and modifying roles of baseline circadian age on intervention outcomes.

Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls

The goal of this study is to conduct a randomized pilot multi-arm clinical trial comparing a standard course of physical therapist provided pelvic floor muscle training (PFMT) to pharmacologic therapy for the treatment of urgency urinary incontinence (UUI) or Overactive Bladder (OAB) in older women at high risk of falling. The central hypotheses for this project are i) a randomized pilot multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling is feasible; and ii) treatment approach can influence both UI and fall related outcomes in this patient population. The main questions it aims to answer are: 1) Is a multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling feasible? and 2) How does treatment approach influence both OAB and fall related outcomes in this patient population? Women (16 per arm) 60 years and older with UUI or OAB who screen positive for high fall risk will be randomized to one of three standard of care treatment arms and followed for six months. The three treatment arms are i) a 12-week structured behaviorally based pelvic floor muscle training (PFMT) intervention administered by physical therapists in the outpatient physical therapy clinic; ii) a 12-week course of the beta-3 agonist, Mirabegron; and iii) a 12-week course of the antimuscarinic, Trospium Chloride. Researchers will compare study feasibility and OAB symptom related outcomes across the three groups to see if a larger clinical trial is warranted.

Virtual Reality for Walking and Balance in Older Adults

Falls are common in older adults due to aging-related problems with walking (gait) and balance. Virtual Reality (VR) is a new technology that creates interactive video game-like exercises. This study aims to see if VR training works better than traditional physical therapy exercises for improving walking and balance in adults aged 60 years and older who live in the community. Half of the 36 participants will use a VR headset to play movement games, while the other half will do standard exercises like tandem walking. We will measure their walking speed, step length, and balance before and after 4-6 weeks of training.

SAFER Karachi - A Fall Prevention Intervention

The goal of this pilot study is to evaluate the feasibility, acceptability, and short-term effects of a culturally adapted and strengthened fall prevention program in older adults aged 60 years and above living in urban Karachi, Pakistan. The study aims to understand whether a structured, community-based intervention can improve mobility, confidence, and overall well-being, while reducing the risk of falls. The main questions it aims to answer are: 1. Is the adapted and strengthened fall prevention program feasible and acceptable for older adults in Karachi? 2. Does participation in the program improve mobility, balance, fall-related self-efficacy, and emotional well-being among participants? Participants will: 1. Take part in a 7-week group-based fall prevention program that includes strength and balance exercises, home safety education, medication awareness, and behavioural strategies 2. Receive a follow-up home visit to reinforce safety practices and environmental modifications 3. Attend a booster session after 3 months to support continued engagement 4. Complete assessments at baseline and follow-up, including mobility, cognitive function, quality of life, and emotional well-being 5. Maintain monthly fall logs to report any fall incidents during the study period

Use of the KASPARD System for Fall Prevention in Nursing Homes

Falls are a frequent cause of admission to nursing homes \[2\]. It is also the most frequently reported adverse event in these institutions. The prevention of falls in EHPAD must mobilise several levers of action and involve all staff. It must be included in the establishment's project in the same way as the policy on the proper use of restraints \[21\]. Home automation and new technologies can contribute to the prevention of falls and their consequences. Most of the existing solutions on the market are either fall detection solutions based on a watch or pendant or rise detection solutions based on a sub-mattress or floor mat. All of these solutions work with a contact and often require a daily set-up or check by the care teams. But the real challenge today for new technologies is to prevent falls in the elderly, by directly addressing the risk factors. KASPARD is a non-contact (remote sensors) and non-intrusive (no video image, it uses point cloud technology) solution for detecting falls, excessive wandering and nocturnal activities in a nursing home. The information is transmitted securely via the wifi network to a mobile phone (or TSI/DECT) and to a computer. The KASPARD solution, which is already on the market (non-medical CE marking), is used in several EHPADs in Belgium and France. It is not a medical device. To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data). We wish to verify the effectiveness of the KASPARD technology for the prevention of falls in EHPAD, suggested for the moment by an observational study, with the help of a multi-centre clinical study

Feasibility of Home-based tES for Older Adults at Risk of Falling

In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tES (transcranial electrical stimulation) intervention to improve mobility in ambulatory older adults with recent falls. This is a four-phase feasibility study in older, ambulatory adult participants at risk of falling due to a loss of balance (participant faller, PF) together with a willing and able participant administrator (PA) that is available during weekdays to administer tES to the PF. Phase 1 is focused on the development and refinement of our training materials for home-based tDCS (transcranial direct current stimulation) for PF/PA pairs. The objectives of this phase: 1. Identify areas of confusion and challenges for older adults. 2. Refine our training materials to accompany the home-based tDCS system. In Phase 2, the investigators will complete a pilot trial in 12 PF/PA pairs to assess the feasibility of deploying home-based tES in larger clinical trials, and to prepare for the development and implementation of such trials. The objectives of this phase: 1. Determine the mean/range number of visits needed for in-person training. 2. Compliance and retention with the study protocol. 3. Safety/side effects of home-based tES, as compared to previously established laboratory-based tES data. The investigators hypothesize that adult PAs are able to successfully administer home-based tES to PFs. The investigators also expect that PF/PA pairs will exhibit excellent adherence to the intervention and that the prevalence and severity of reported tDCS side-effects will be similar to that observed in previous laboratory-based studies. In Phase 3, the investigators will complete a pilot trial in up to 18 PF/PA pairs; i.e., those who have previously successfully completed either Phase 1 or Phase 2. The study objectives/aims for Phase 3 are: 1. Further explore compliance and retention with the study protocol over a longer time period 2. Identify safety/side effects of home-based tES over a longer time-period as compared to previously established laboratory-based tDCS interventions. In Phase 3, the investigators hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will retain competence and compliance with administration over a longer period, up to 1 year. In Phase 4, we will complete a pilot trial in up to 18 PF/PA teams; those who have previously successfully completed Phase 3. The study objective/aims for Phase 4 will be to: 1. Identify Safety, effectiveness and adherence to home-based tES over longer period of time as compared to previously established laboratory-based tES interventions. 2. Further explore the proof of Concept for the home-based tES interventions In Phase 4 we hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will adhere with the study protocol over a longer period of time, up to 3 years.

Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients

The purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.

Development of Pressure Sensor Based Dementia and Fall Prevention Program for Older Adults

The goal of this intervention program is to test the effectiveness of pressure sensor based dementia and fall prevention program for improving cognitive and physical functions of community dwelling older adults. The main purposes of this study are: 1. Develop a pressure sensor based exercise mat and linked software programs to be used for group training sessions for cognitive and balance training of older adults at a community senior center. 2. Evaluate efficacy of the program to improve cognitive and physical functions of older adults via a pilot study and a main study with randomized control trial design. Older adults will be asked to participate in a group training session that was lead by a fitness coach using a pressure sensor mat, a standing monitor, and a linked software programs. They will be asked to stand on the mat, which is set in front of a monitor to show positions of the mat where they place their foots. The monitor screen will guide them to conduct either a balancing exercise for fall prevention or a cognitive exercise such as memory game or quiz game for dementia prevention. Researchers will compare age and gender matched control group in a main study to see if cognitive and balancing functions of intervention group is better than the control group by conducting pre and post surveys and physical examinations. A pilot study will examine pre-post changes in the intervention group without the control group.

Fall Prevention in Older Adults in an Italian Cohort

Proximal femoral fractures are associated with increased mortality in older adults and may contribute to loss of functional independence, resulting in a higher risk of long-term institutionalization. The SIOT 2021 guidelines emphasize that management of older patients with proximal femoral fracture (FPF) requires a multidisciplinary approach, ideally integrated across all phases of care, including rehabilitation and secondary prevention at the community level, according to a continuity-of-care model that incorporates the implementation of Fracture Liaison Services. Multiple clinical, social, and environmental factors influence fall risk. Falls are also associated with psychological consequences. Age-related reductions in muscle strength contribute to progressive functional decline, increased morbidity and mortality related to falls, reduced quality of life, depression, and hospitalization. Sarcopenia is characterized by both quantitative and qualitative reductions in muscle tissue, including progressive replacement of contractile tissue with fibrous and adipose tissue. The European Working Group on Sarcopenia in Older People (EWGSOP), in its updated consensus (EWGSOP2), identifies low muscle strength as the primary parameter of sarcopenia, accompanied by a significant and generalized reduction in muscle mass. A use-case model dedicated to patients with sarcopenia describes typical demographic and social characteristics, associated comorbidities, and specific care needs, with the aim of identifying the most appropriate management pathways. This study adopts a person-centered approach to design, validate, and implement an integrated strategy for fall prevention, taking into account the multiple determinants of fall risk and related adverse health outcomes.

Health Belief Model-Based Web Education for Preventing Home Accidents in Mothers of Children Aged 0-3

This randomized controlled experimental study evaluates the effect of a Health Belief Model (HBM)-based web education program on preventing home accidents among mothers of children aged 0-3 years registered in a Family Health Center in Erzurum, Türkiye. Unintentional injuries such as falls, burns, poisoning, choking/aspiration, and cutting/piercing injuries are common in early childhood and often occur in the home environment. Mothers play a critical role in recognizing home hazards and implementing preventive safety behaviors. Participants will be randomly assigned to either an intervention group (HBM-based web education) or a control group (usual care). The intervention includes a structured web-based education program delivered over three months, supported by reminder messages via WhatsApp, interactive communication through an "Ask Us" option, and two Zoom meetings during the follow-up period. Outcomes will be measured using the General Self-Efficacy Scale and the Mother Home Accidents Awareness Scale. Baseline data will be collected through face-to-face interviews before the intervention, and post-test data will be collected at the 6th month. The study aims to determine whether HBM-based digital education improves maternal self-efficacy and awareness regarding home accident prevention.

Technology Supported Improvement, Management and Prevention of Accidental Falls in Hospitals

The student will observe fall prevention systems in practice in 2 different hospitals considering how fall prevention technology influences staff behaviour and patients safety in the context of accidental falls in hospital. Accidental falls in hospital are rare but can be life changing for those that suffer them as they are often frail patients who are already vulnerable. Current research shows little improvement with any interventions tested which leaves patient facing clinicians with few resources to assist in the prevention of falls. The investigator believes this is because the measure of accidental falls in hospital is not sensitive enough to calibrate for the different contexts in which patients fall. The student would posit that it is the context that is most influential and addressing the context may lead to improved measures so progress can be made in finding solutions.

A Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment

To determine the efficacy of a dual-task tai ji quan training therapy in reducing the incidence of falls in older adults with mild cognitive impairment.