Clinical Research Directory

HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide

This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of usual clinical care. Participants will receive calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months. The primary outcome is change in appendicular lean mass measured by dual-energy X-ray absorptiometry from baseline to month 6. Secondary assessments include body composition, muscle strength, physical performance, gait, physical activity, resting metabolic rate, metabolic measures, and whole-body quantitative computed tomography. An optional mechanistic substudy of up to 36 participants will include D3-creatine dilution, nonradioactive stable isotope infusions, repeated blood sampling, a standardized meal, breath sampling, and vastus lateralis muscle biopsies at baseline and month 6.

AI-Adaptive AR Training for Balance and Falls Prevention in Older Adults

Falls are a common problem in adults within the age of 55-80 years and can lead to injury and loss of independence. This study is testing a new type of balance training using augmented reality (AR). In this intervention, participants will see virtual objects, such as obstacles, placed in their environment and will practice stepping over or moving around them. The system will adjust the difficulty based on each person's performance. Participants will complete training sessions over several weeks. We will measure changes in balance, walking ability, and confidence before and after the program. The goal is to see if this training can help improve balance and reduce the risk of falls in older adults.

Evaluation of Choose to Move Replacement Ready (CTM-RR)

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery. The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.

Wearable Sensor for Early Detection and Monitoring of Cognitive Decline

This observational study will enroll approximately 100 participants evenly split by cognitive status (Cognitively Impaired vs Non-Cognitively Impaired), and involves four clinic visits over one year (at baseline, 3, 6, and 12 months), each followed by 7 days of remote monitoring to assess the long-term feasibility of PAMSys+ (Physical Activity Monitoring System).

Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults

This randomized controlled trial study aims to evaluate the feasibility and preliminary efficacy of a combined inspiratory muscle training (IMT) and blood flow restriction (BFR) intervention in frail older adults. Outcomes of interest include feasibility, physical function, respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events.

Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study

The purpose of this research study is to explore ways to improve motor, cognitive and immune functions for aging adults using multiple techniques like lifestyle changes and risk factor management, as well as medications and supplements believed to have a positive effect on health.

The Effect of IoT-based Smart Exercises System in the Senior Adults: Resistance Band Training System

Subjects are divided into two groups, (1) Control (Ctrl) and (2) Smart Exercise (SE) group. Participants in the Ctrl group are instructed to perform resistance band training twice weekly according to a paper-based exercise guide, whereas participants in the SE group are instructed to perform resistance band training twice weekly for 12 weeks using the Resistance Band Training System. The physical fitness tests and questionnaire of both groups are performed before and after the 12-week exercise program.

N-of-1 Trial to Promote Beta-Blocker Titration in Heart Failure

In this study we seek to understand whether N-of-1 trials using a crossover withdrawal/reversal design with as many 2-week periods can be used to identify the highest tolerated beta-blocker dose for patients with Heart Failure with Reduced Ejection Fraction (HFrEF). To achieve this objective we will conduct a 2-arm randomized controlled trial of 50 participants, comparing intervention(N-of-1 trials) to enhanced usual care. For participants randomized to the intervention, we will use collect data via validated patient-reported outcomes and then display this data on a visualization tool. This tool was iteratively developed for N-of-1 trials with patient input - a comparison of how the patient felt on different beta-blockers. If well-tolerated and the participant agrees to continue with dose escalation based on review of their data, the participant will take a higher dose for the next 2-week period; and the study team will again collect data on how they feel during this time. This approach of sharing end-of-period data with participants and subsequently escalating the dose (based on the participant's decision) for another 2-week period will continue until the guideline-directed target dose is reached or until the participant feels that their symptoms are limiting dose escalation. The N-of-1 intervention is purposefully structured to allow the participant to participate in as many periods (and as many dose combinations) as they wish until they are confident that they have reached their highest tolerated dose. This adaptive design for N-of-1 trials is intended to be patient-centered and patient-driven. We will also conduct brief semi-structured interviews with intervention participants. Participants randomized to enhanced usual care will not have access to patient-reported outcomes or the data visualization tool. Since attention can affect outcomes, we will "enhance usual care" by conducting phone calls at the same frequency as the intervention group.

Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging, electrophysiological (EEG), and autonomic physiology will be used to assess the neural correlates of the intervention. EEG and autonomic physiology will be collected while participants watch 30 min of an awe-inspiring movie. fMRI and autonomic physiology will be collected in the context of a social exploration/exploitation task.

Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients

Delayed neurocognitive recovery is a common neurocognitive complication in older patients after surgery, especially those with preoperative neurocognitive decline. Transcranial photobiomodulation therapy is a novel neuromodulation technique using transcranial low-power light to modulate brain biological functions. This technique has been used to treat various neurological or psychiatric conditions, including ischemic stroke, traumatic brain injury, and major depression. This study is designed to explore whether using transcranial photobiomodulation therapy during the perioperative period can reduce the incidence of delayed neurocognitive recovery in older patients with pre-existing neurocognitive impairment.

The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study

This study aims to examine 1) if multicomponent exercise interventions (including both mobility and strengthening exercises) have effects on physical function compared to usual care in older adults, and 2) if a comprehensive multicomponent exercise program is more effective than a simple multicomponent exercise program including only walking and rising from a chair.

Geriatric Trauma Care Program for Living Alone Older Adults With Injuries

To examine the long-term effects of the Geriatric Trauma Care Program (GTCP) regarding pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone.

Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults

Objectives: To develop an exercise program for older adults with low back pain. And,to develop a clinical prediction rule that could identify a subgroup of people with NSLBP Participants: 150 people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6 months and is able to ambulate independently will be invited to join the study. People who had 1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture, recent fall, tumour, or bone infection; and 4) experience of practising core-stability exercises in the past 6 months will be excluded. Study details will be explained to participants and written consent will be obtained prior the study. 75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group. Assessment Participants will undergo two comprehensive assessments before and after the training, which includes: Surface electromyogram (EMG) on the lumbar spine and abdominal muscle, Inertial measurement unit (IMU) sensor for trunk movement, clinical assessment including. Prone instability test. Subjective assessments: Visual analogue scale score for pain, The Oswestry Low Back Pain Disability Questionnaire and Roland-Morris Disability Questionnaire. Intervention - 16 session structured exercise program All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6 - 8 per class Subjects will be divided into experimental and control groups. Participants in the control group will not receive exercise training at first but were evaluated at the same time as participants in the experimental group. The participant in the control group completed the exercise training after the post-assessment.

Person-Centered Occupational Therapy in Older Adults

This study was designed to investigate the effects of a person-centered occupational therapy approach on quality of life and occupational balance among community-dwelling older adults. The study is a randomized controlled trial utilizing semi-structured interviews and self-report measures. The target population consists of individuals aged 65 years and older living in Istanbul. The sample size was calculated using G\*Power software, indicating a minimum of 77 participants per group, for a total of 154 participants. Considering potential attrition, a total sample of 170 participants is planned. Data will be collected using a Sociodemographic Information Form, the Mini-Mental State Examination (MMSE), the Occupational Performance History Interview-II (OPHI-II), Goal Attainment Scaling (GAS), the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD), and the Activity-Role Balance Questionnaire. Cognitive eligibility will be assessed using the MMSE, and individuals scoring 24 or higher will be included in the study. Through the OPHI-II, participants' life histories, roles, habits, and experiences related to daily activities will be explored, and individualized goals will be identified based on the information obtained. These goals will subsequently be structured using the Goal Attainment Scaling method. Participants will be randomly allocated to either the intervention group or the control group. Participants in the intervention group will receive person-centered occupational therapy sessions delivered via telerehabilitation, while those in the control group will continue their usual daily routines without additional support. At the end of the study, outcomes related to quality of life and occupational balance will be compared between groups. The findings are expected to provide evidence regarding the role of a person-centered occupational therapy approach in supporting participation in daily life activities among older adults.

CHANGES IN SLEEP QUALITY AND BODY COMPOSITION FOLLOWING A MULTIMODAL LIFESTYLE INTERVENTION IN OLDER WOMEN

This single-arm pilot study evaluated changes in sleep quality, body composition, biochemical parameters, physical activity, and psychological well-being following a 12-week multimodal lifestyle intervention in overweight and obese women aged 60 years and older. The intervention included individualized nutrition counseling, regular psychological support, and encouragement to walk for at least 150 minutes per week. Participants were assessed at baseline and at the end of week 12. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index. Secondary outcomes included anthropometric measurements, biochemical parameters, physical activity level, and psychological well-being.

Building Resilience for Surgical Recovery

The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?

Impact of Respiratory Muscle Training on Cognition in Older Adults

The increase in chronic diseases associated with aging leads to various physical limitations in older adults, negatively impacting fall risk, hospitalization rates, and overall mortality. While Inspiratory Muscle Training (IMT) is frequently utilized in rehabilitation programs due to its low cost and ease of use to enhance respiratory muscle strength, balance, and functional capacity, its potential effects on cognitive function remain unexamined. The primary objective of this pilot randomized controlled trial is to investigate the effect of an 8-week Inspiratory Muscle Training (IMT) program on cognitive function in older adults. A secondary objective is to examine the relationship between cardiovascular risk factors and respiratory muscle strength in this population. Researchers hypothesize that an 8-week IMT intervention will have a significant effect on cognitive function in older adults compared to a control group. To test this hypothesis, a total of 24 eligible older adults will be randomly assigned to either perform daily breathing exercises using an external device for 8 weeks or maintain their routine daily activities. Both groups will be assessed at baseline and after the 8-week period to evaluate changes in cognitive, functional, and physical parameters.

Improving Needs Among Older Adults

Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect. ICUconnect facilitates families' and patients' self-report of actual palliative care needs across all core domains of palliative care quality, provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care, and provides a variety of informational supports relevant to each user's role. In this RCT, the investigators will test ICUconnect vs. usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population (Duke, Medical University of South Carolina, University of Alabama at Birmingham, Columbia). The specific aims are to: (1) Test the efficacy of ICUconnect vs. usual care control in improving palliative care needs and other person-centered outcomes including psychological distress, (2) Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach, and (3) Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data.

tVNS During Motor Training in Older Adults

The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation.

A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program

The goal of this clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (SMI) increase their social connections and participate in more healthy lifestyle activities. The Hopeful and Healthy Living (HHL) intervention combines social skills training and training in cognitive self-management strategies in order to help older adults build healthy lifestyle and social routines. We predict that: * Individuals who participate in the HHL intervention will improve more in perceived social support (i.e., what people get from relationships such as reliance, reassurance of worth, attachment) and loneliness at the 4-, 8-, and 12-month follow-up assessments than those who receive treatment as usual (TAU). * Individuals who participate in the HHL intervention will improve more in overall psychosocial functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. * Individuals who participate in the HHL intervention will improve more in cognitive functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. * Individuals who participate in the HHL intervention will improve more in healthy behaviors (sleep, activity, diet) at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. In this trial, participants will be either receive the HHL intervention or participate in their regular treatment activities (treatment as usual). HHL vs. TAU will be compared to see if there are any differences in social support, cognition, loneliness, psychosocial functioning, or healthy lifestyle activities including physical activity, sleep, and diet. Participants will be asked to complete an interview-based assessment at baseline, 4-months, 8-months, and 12-months. After completing the baseline assessment, those who are in the experimental group will participate in the 16-week long HHL group intervention.

WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT

The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD/ADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). The main questions this study aims to answer are: * How effective is the WeCareToFeedDysphagia tool in reducing feelings of burden in care partners? * Does the WeCareToFeed Dysphagia tool help improve patient outcomes? * Does care partner age, gender, and patient dysphagia severity impact the strength of the effect of the WeCareToFeedDysphagia tool? * Is the strength of the effect of the WeCareToFeedDysphagia tool impacted by care partner's beliefs in being able to manage behavior and stress (self-efficacy)? Researchers will compare a group of care partners who have access to the WeCareToFeedDysphagia tool (intervention) to a group of care partners who do not have access to the tool. Both groups will receive contact information for help from a speech language pathologist expert (enhanced usual care). Participants will: * be given access to the web tool and receive 3 text message reminders over 3 weeks to use the tool (intervention group only). * be asked to complete a remote, web-based survey three times: when enrolled in the study, at 1 month following patient leaving the hospital, and at 3 months following patient leaving the hospital.

Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic

This multicenter, prospective, non-interventional observational study (ORTOPODCZ) investigates the association between preoperative cognitive impairment and postoperative delirium (POD) in older adults undergoing elective total hip arthroplasty in the Czech Republic. Postoperative delirium is a frequent and serious neurocognitive complication in senior surgical patients and is associated with increased morbidity, mortality, prolonged hospitalization, and impaired functional and cognitive outcomes. Despite international recommendations, routine preoperative cognitive screening remains insufficiently implemented. The study evaluates the predictive value of the ALBA test, a brief cognitive screening tool, performed during the pre-anesthetic assessment. Postoperative delirium will be assessed using the validated CAM-ICU instrument for up to 72 hours after surgery. Secondary objectives include assessing the relationship between POD and frailty, polypharmacy, comorbidities, type of anesthesia, intraoperative hemodynamics, blood loss, vasoactive support, and postoperative complications. Approximately 300-400 participants aged ≥65 years will be enrolled across seven centers. No additional procedures, biological sampling, or deviations from standard clinical care are required. Data will be collected in REDCap and analyzed according to a predefined statistical analysis plan. The study aims to provide robust evidence supporting the integration of cognitive screening into routine preoperative evaluation and to describe feasibility and implementation requirements for the ALBA test in clinical practice.

Aging and Mixed Perturbation Training to Reduce Falls in Locomotion

The long-term objective of this research is to develop an efficacious training paradigm to enhance older adults' defense mechanisms against falls and possibility reduce healthcare cost. The Centers for Disease Control and Prevention estimates the direct medical cost for fall related injuries to be $30 billion annually. Slips and trips combined account for more than 50% of the outdoor falls in community-dwelling older adults. These environmental perturbations are opposing in nature, with slips mainly resulting in backward falls and trips in forward falls. This project explores perturbation training through both slip and trip exposure based on the principles of motor learning. The project design consists of a randomized controlled trial to examine the ability of the central nervous system to mitigate the interference in stability control (if any) that is induced by opposing types of perturbations. It also introduces a novel combined slip and trip perturbation training paradigm to enhance one's ability to retain and generalize the acquired fall-prevention skills to both types of falls. Slips and trips induced on an over ground walkway will be used to prepare the motor system to improve stability control and vertical limb support to resist falls. The longer-term benefits of such combined perturbation training over exclusive slip-only or trip-only perturbation training in reducing both laboratory-induced and real life falls will also be assessed. The hypothesis of this study if supported by the results will provide an evidence-supported training protocol to reduce the fall-risk among community-dwelling older adults.

Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline

The investigators aim to conduct a randomized controlled trial to compare two symptom-management programs for Black older adults with early cognitive decline (self-reported confirmed by testing) and chronic pain. The programs are Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED). The investigators will assess how each program may help in improving physical, cognitive, and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.