Clinical Research Directory

Brief Behavioral Therapy for Insomnia (BBTi) in Middle-aged and Older Adults With Chronic Insomnia

This study aims to investigate whether a nurse-led brief behavioral therapy can effectively improve chronic insomnia and sleep health in older adults.

Line Dancing With Blood Flow Restriction for Balance and Gait of Older Women (In-Person vs Online)

Falls are a leading cause of injury-related hospitalization among older women. Age-related declines in gait speed and postural stability are known risk-factors for falls. While exercise is well-known to help maintain or improve these losses, only 24.4% of older Canadian women are considered physically active. Dance can act as a fun and social way to engage older women in exercise. Line dancing in particular has been shown to improve gait speed, knee extensor strength and endurance; however high doses are needed to achieve gains. Clifford and colleagues found that program lengths of 24 hours are needed to effect change, while Merome and colleagues recommend 3 hours per week. These high training doses may not be feasible for participants or community centres who offer programming. The time to commute to classes, find parking and caregiver roles at home are all cited as barriers to physical activity. We also propose that BFR could be a novel addition to increase the physiologic strain of online dance classes, which we hypothesize have a lower intensity and thereby lead to less fitness adaptations. Online classes are of interest as they can serve to reduce barriers to physical activity often experienced by older adults in Canada. * We propose online dance classes have reduced efficacy in stimulating adaptations to gait speed, strength and endurance when compared to in-person classes. * We propose blood flow restriction (BFR) as a novel addition to dance classes in order to aid in reaching physiological overload in more efficient time-frame. BFR works by partially reducing blood flowing in and out of working muscles, thereby reducing oxygen availability, promoting anaerobic energy pathways and keeping metabolites in the muscles for a longer time period. Numerous studies have confirmed that when combined with low-intensity exercise BFR is capable of producing similar strength gains as high-intensity exercise. Additionally, BFR is safe and has been widely used among older adults and individuals with various medical conditions, including cardiovascular conditions. While the benefits of BFR for muscle strength and hypertrophy have been greatly studied, there is limited research on its effects on gait and postural stability. Additionally, there is minimal research on potential combinations of BFR with dance-based activity. * This study will examine the differences between online and in-person delivery of 90 minute line dance classes on the postural stability and gait of older females over 10-weeks. * This study will then investigate the effects of combining BFR with 10-weeks of 90 minute line dancing classes for the postural stability and gait of older females. Finally, muscle oxygenation and kinematic analysis will be conducted to help provide insight into any potential changes in gait and postural stability. The intervention will consist of 10-weeks of line dancing classes, during which half the groups will be randomized to wear elasticized BFR bands pulled tight to a 7/10 of perceived pressure. Classes will be once per week for 90 minutes and will include a warm-up, 4 pre-set choreographies and a cool down. Breaks will be provided throughout the class. Assessments will occur at pre, mid and post. Gait will be assessed during a 6-minute walk test. During the test, participants will be filmed from a sagittal view to obtain kinematics. They will also be asked to wear a heart-rate monitor and muscle oxygenation sensors on their lower limbs. Postural stability will be assessed via 30-seconds of quiet standing on force plates in conditions of eyes open, eyes closed and foam. Participants will also be asked to wear an accelerometer on their upper back during the assessment to obtain correlation to force plate data. Functional strength will be assessed using 30-second sit to stand (with a secondary timer to obtain 5 time sit to stand length) and the Calf-Raise Senior test. Dynamic balance and mobility will be evaluated using the Functional Reach Test, and the Timed Up and Go in both single and dual-tasks. Aerobic capacity will be measured using a 3 minute Step Test while the participant wears a heart-rate monitor and muscle oxygenation sensors. Finally scales of fears of falling, social connectedness, and overall mental health will be collected. It is expected that this study will have great practical implications as the accessibility of this program can provide opportunities to older adults from various remote locations to increase their levels of physical activity in a safe manner. The affordability may also aid in adoption by community health and recreation centers as an easy-to-implement program that helps to improve the postural stability and gait of older women, thereby promoting independence and quality of life.

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.

Frailty, Geriatric Syndromes and Care Pathways of Older Adults Living With HIV in West Africa

With currently available antiretroviral therapy, people living with HIV (PLWHIV) are living longer. This exposure to HIV and combination antiretroviral therapy may accelerate the aging of this population, thus increasing the prevalence of premature frailty. There are few data on the prevalence of frailty and geriatric syndromes among older people living with HIV (OpHIV) in sub-Saharan Africa (SSA) and the screening and diagnostic tools to identify them. The initiation contract financed by the ANRS-MIE in 2021 whose objective was to 1) carry out an inventory and evaluate the feasibility of a project for monitoring OpHIV in Burkina-Faso in Côte d'Ivoire and Togo and 2) to select the collection tools adapted to the description of geriatric syndromes in these elderly people has allowed to highlight the following (i) The collection of data on geriatric conditions and syndromes is almost non-existent in the daily care and management practice (ii) there is a significant proportion (10,6%) of PLWHIV aged 60 years and over in the active files of the PLWHIV care centers that participated in the survey (iii) Adapted screening tools have been selected and will allow documentation of the above-mentioned syndromes. This research project, which follows on from this initiation contract, will therefore make it possible to obtain data from the geriatric evaluation, to identify the specificities of PLWHIV by comparing them to a population not infected with HIV and to propose geriatric management adapted to PLWHIV. Its innovative nature also lies in its mixed approach combining quantitative and qualitative methods, which will make it possible to document the needs and resources for the care of PLWHIV in a global and holistic manner. 600 participants, aged 60 years and over (300 living with HIV and 300 not living with HIV), in three West African countries (Burkina Faso, Côte d'Ivoire, Togo) will be included in this study whose primary objective is to compare the prevalence of frailty among people aged 60 years and over (PA60) between HIV-infected and non-HIV-infected; the secondary objective is to estimate the prevalence of frailty among PA60 according to HIV status. A population-based matching will be performed on sex and age class (threshold 70 years), during the recruitment of HIV- PA60. This will be a mixed study combining: * A "clinical" component comprising a stratified, comparative, international, multicenter cross-sectional study; * A "health systems strengthening" component combining a quantitative cross-sectional survey and a qualitative survey; * A qualitative socio-anthropological component including individual interviews and focus groups with people living with HIV60, their families and caregivers. The 3 components will be conducted with a time lag between the different components due to the overlapping constitution of the source populations. Most research on aging with HIV in the context of SSA has been very clinically focused (e.g., frailty or cognitive impairment). This research will provide a more comprehensive approach that takes into account the different levels of factors influencing health (individual, health system, social environment).

Melatonin Supplementation and Exercise Program in Breast Cancer Women

Introduction: Breast cancer (BC) remains the leading cause of cancer in women with nearly 1.4 million new cases worldwide annually and 27.000 in Spain. Increasingly effective oncology therapies, however, have numerous adverse effects such as muscle degeneration, fatigue, decreased physical function and aerobic capacity, and deteriorating quality of life. In this sense, physical activity (PA) seems to be an interesting non-pharmacological strategy to alleviate these serious complications and with potential benefits for women with BC. Melatonin (N-acetyl-5 methoxytryptamine) is an indolic compound present with pleiotropic bioactions that regulates the circadian rhythm, antioxidant, anti-inflammatory, immunostimulant, cardioprotective, antidiabetic, antiobesity, neuroprotective, and antiaging actions. Furthermore, in recent years, many studies have described the key role of melatonin in preventing and developing cancer. The general anticarcinogenic mechanisms include epigenetic control, cell proliferation modulation, cell cycle regulation, apoptosis induction, and telomerase inhibition. Melatonin also exerts antiestrogenic activity, which is particularly significant in hormone-dependent tumors, regulating the expression and transactivation of the estrogen receptor, and modulating the enzymes involved in the local synthesis of estrogens. Despite all the mentioned properties, the use of melatonin in daily clinical practice is very limited, and additional studies are needed to better establish the role of this hormone in oncological clinical applications against different types of cancer. Objective: To analyze the effect of supplementation with 4 g/day of melatonin for 10 weeks on muscle damage (CK and LDH), hormonal responses (estradiol, testosterone, cortisol and testosterone/cortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (handgrip strength, RPE and SPPB), anthropometry (body mass, BMI and fat mass) and WHOQOL-BREF (physical and psychological health, social relationships and environment) in women over 60 years of age who have suffered breast cancer and who follow a physical training program. Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.5±4.52 years, BMI: 25.83±2.67 and body fat percentage: 33.73±5.54) who followed a physical activity adapted to their age and abilities are the members. of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 5 g/day of melatonin (GI; n = 10). Differtent test were performed muscle damage (CK, and LDH), hormonal responses (estradiol, testosterone, cortisol, and testosterone/cortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (Hand-grip strength, RPE and SPPB), anthropometrics (Body mass, BMI and fat mass), and WHOQOL-BREF (physical and psychological health, social relationships and environment) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2).

A Multi-Level Strategy for De-implementing Mammography Overuse Among Older Women

This project aims to advance methodological and theoretical approaches for developing, selecting, refining, and piloting a multilevel de-implementation strategy to reduce the overuse of screening mammography in women aged ≥75 years. Informed by an innovative participatory, stakeholder-driven innovation tournament and a discrete choice experiment, the research team identified, prioritized, and tailored a multilevel de-implementation strategy. The research team will conduct a cluster randomized controlled trial (at the provider level) to test the impact of the provider- and patient-level components of the multilevel strategy on screening mammography use, and secondarily, on provider referrals/orders for screening mammography. The organizational level components of the multilevel strategy will be implemented among all participants, not via random assignment.

Making Intergenerational Connections Through Arts

The purpose of the study is to evaluate the impact on older adults' wellbeing of participating in a 10-week conversation about arts and culture with an international university student whose native language is not English.

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 1-5 three-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 doses of the same beta-blocker. 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 3-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 3-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 1-5 three-week 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.

Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program

The goal of this study is to evaluate the effectiveness and implementation of a dyadic management of the Chronic Disease Self-Management Program (CDSMP) for older adults with co-occurring cognitive impairment and diabetes with the involvement of caregivers. The main questions it aims to answer are: * Does the intervention improve diabetes self-management and cognitive function in older adults? * How is the implementation of the intervention in real-world settings? Participants will: * Attend weekly CDSMP session over a 6-week period (2.5-hour per session). * Provide feedback on their experience with the intervention through interviews and surveys.

SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults

The goal of this randomized controlled trial is to investigate the effectiveness of a health-coaching intervention to improve physical activity in older adults with limited mobility when compared to a control, health education group.

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).

Senior Center Medication Safety and Empowerment Curriculum

Team Alice's Medication Safety and Empowerment Curriculum (MedSEC) helps older adults and caregivers learn how to safely manage medications. Many seniors take multiple medications, which can lead to harmful side effects or unnecessary treatments. This program, developed at the University at Buffalo, will be offered at senior centers in Western New York. It includes two interactive sessions that teach participants how to recognize medication risks and talk with their doctors about safer options. The curriculum uses videos, group discussions, and hands-on tools to build confidence and knowledge. It follows the "4Ms" of Age-Friendly Health Systems: What Matters, Medication, Mentation, and Mobility. A "Train-the-Trainer" model will help senior center staff continue the program long-term. The goal is to reduce medication harm, improve communication with healthcare providers, and support healthy aging in the community.

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.

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.

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.

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.

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.

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.

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?