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Showing 1-20 of 173 trials
NCT07570628
This observational study aims to evaluate the real-life use of a digital tool (Fragiclic) by general practitioners (GPs) and nurses to screen and assess frailty in adults aged 65 and over. Frailty is a syndrome that increases the risk of loss of autonomy, falls, hospitalizations, or death. The tool includes simple screening questionnaires (such as SEGAm) and a comprehensive assessment (CGA - Comprehensive Geriatric Assessment) to better manage patients' health. The main question it aims to answer is: * What proportion of patients aged 65 and over will benefit from frailty screening or assessment using Fragiclic over 12 months? A secondary question is \- Does the use of Fragiclic reduce the risk of unplanned hospitalizations or death in these patients? For the secondary question, researchers will compare patients who received screening or assessment (with or without a Personalized Care Plan (PCP)) to those who did not, to determine if Fragiclic improves their health outcomes. Participants will not have additional tasks: Their GP or nurse will use Fragiclic during routine consultations. Some patients may be asked to provide information about their health or quality of life (via their healthcare provider). All data will be collected anonymously and securely
NCT07386730
This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology. 2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology. 3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below. Researchers will compare participants who receive the following drug options: * A low-to-moderate dose of Psilocybin (5-10 mg) * A moderate-to-high dose of Psilocybin (25-30 mg) * A low-to-moderate dose of Dextromethorphan (30-60 mg) * A moderate-to-high dose of Dextromethorphan (80-90 mg)
NCT05860088
The goal of this controlled-feeding cross-over diet intervention is to compare a beef diet to a vegetarian diet on muscle fatigue in older adults. The aims are: AIM 1: To test the hypothesis that muscle fatigue is attenuated in older adults consuming beef compared to older adults consuming a plant-based diet. AIM2: To test the hypothesis that daily beef consumption improves biochemical indicators related to muscle fatigue. Participants will be randomized to consume either a beef-based diet or vegetarian diet under controlled-feeding conditions for 8 weeks. After a 2-week washout period, participants will cross-over to consume either the beef diet or vegetarian diet for 8 weeks. Body composition and functional muscle outcomes will be measured during each 8-week feeding period. Blood samples will also be collected.
NCT07327541
This study aims to evaluate the cognitive function, physical function, and pain levels of community-dwelling older adults to determine the impact of cognitive ability on physical function and pain. It also seeks to establish foundational data for strategies to prevent dementia and sarcopenia. Therefore, the purpose of this study is to measure the cognitive function (overall cognition, executive function, memory, attention, etc.), physical function (muscle mass, muscle strength, gait and balance ability), and pain of community-dwelling older adults, and to analyze the correlations between these factors.
NCT07522125
This study was aimed to examine the effects of participation in a 12-week multicomponent exercise program on frailty, cognitive function, and sleep quality among older adults. The primary research questions of this study are as follows: 1. Is a multicomponent exercise program effective in reducing frailty levels in older adults? 2. Is a multicomponent exercise program effective in improving cognitive functions (memory, attention, and executive functions) in older adults? 3. Is a multicomponent exercise program effective in improving sleep quality in older adults? The study hypothesizes that participation in a multicomponent exercise program will lead to a reduction in frailty levels, improvement in cognitive functions, and enhancement of sleep quality among older adults. Researchers were compared the multicomponent exercise program to a control group (no intervention) to see if the multicomponent exercise program works on frailty, cognitive function, and sleep quality among older adults. Intervention group participants were: \- attended the multicomponent exercise program, 12-week period, with sessions held twice weekly, each lasting 45-60 minutes, in groups of 6-8 participants at a municipally affiliated healthy living center under nurse supervision.
NCT07274592
The aim is to examine the effect of a psychoeducation program based on the Psychosocial Development Theory applied to older adults on self-critical rumination, self-esteem, and psychological well-being, as well as the relationship between these concepts. The constant and repetitive thinking of older adults about their past mistakes and failures is defined as self-critical rumination, which can have negative effects on mental health, lead to a decline in quality of life, and cause older adults to experience an unhappy process. For this study, a psychoeducation program based on Erikson's psychosocial stages of development was prepared. The program aims to differentiate rumination levels among older adults, provide suggestions on how to reduce these ruminative thoughts, and teach techniques for dealing with repetitive thoughts, thereby equipping individuals with methods to cope with ruminative thinking. It is expected that elderly individuals who acquire this coping method will experience changes in their psychological well-being and self-esteem. This study's examination of the effects of the psychoeducational program on psychological well-being provides a critical contribution to improving the quality of life of elderly individuals.
NCT07507279
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.
NCT06925880
Double-blind randomized placebo-controlled clinical trial with two parallel arms. The main objective is to evaluate the efficacy and safety of creatine supplementation in older adults who have been operated on for total knee arthroplasty and undergoing a usual rehabilitation program. The intervention will consist of daily creatine monohydrate supplementation for 12 weeks. The intervention will start after surgery with a loading dose of 20g/day for 1 week and then continue with a maintenance dose of 5g/day for 11 weeks. Main outcome mesures included muscle mass, muscle strenght, sarcopenia, frailty, functional capacity and physical performance and will be assessed at baseline, 3 and 6 months follow-up.
NCT04479943
The MOVIN (Mobilizing Older adult patients Via a systems-based Intervention) randomized controlled trial is designed to evaluate the impact of the MOVIN intervention on improving the functional ability of older adult hospital patients and reducing their healthcare utilization post-hospitalization. MOVIN is a program to increase patient ambulation while hospitalized. The study's hypothesis is that MOVIN will improve functional outcomes for hospitalized older adult patients by producing a change in nursing practice and culture of ambulation on inpatient units. MOVIN is a unit-based intervention. Therefore all patients on this unit are exposed to the intervention once it is implemented regardless of whether or not they participate in the trial. The study will enroll 360-420 total hospitalized participants 65 years and older for the duration of their stay. It will also enroll any nurses 18 years and older who worked on the units during the study and are willing to fill out surveys.
NCT07117916
Background: The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. The aim of the STRONGER 60+ trial is to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care. Methods and analysis: This 6-month randomized controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 96 participants will be randomized to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same program. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint), and 12 months post-randomization. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.
NCT07489677
Why this research is important? It is estimated that over one third of all older adults are prescribed medication which are known to have "anticholinergic" side effects. These anticholinergic side effects can include an increased risk of falls, delirium, and memory problems. People who have a high number of anticholinergic medications have an increased risk of these side effects. This can be measured as their anticholinergic burden (ACB). Several tools have been developed to assess the ACB score, by checking a person's medication list, with the aim of reducing these medications where possible (deprescribing). The study aim The project team worked with a company to design an online tool which can calculate the total ACB score for patients using their electronic medication list. It can also list the individual anticholinergic medications contributing to that score. Patients with high ACB score will be highlighted to healthcare staff including pharmacists, nurses, and doctors. In this project, we plan to understand how this tool can be used by clinicians in older persons wards to reduce the number of anticholinergic medications prescribed where appropriate. Our approach Working with doctors and pharmacists in one large hospital, we agreed how the tool should be used. First, pharmacists with check weekly using the digital tool how many patients have high ACB scores. Then they would highlight in patients' medical notes the list of medications with high anticholinergic effects using a sticker note. The doctor looking after the patient then sees the note which would prompt him/her to either stop the drug, reduce the dose or switch to a safer drug. We will test this intervention among 50 patients admitted to older people wards. We will collect information before and after receiving the intervention including number and type of medications prescribed, quality of life, and cognition. We will also talk to staff and patients to understand their views about the intervention, any challenges, and how to improve the process. Involving patients and public Two patient and public contributors have been actively involved in developing this research proposal. They represent an older person with comorbidity and polypharmacy and a carer, and both have lived experience of managing polypharmacy following hospital admission. They will continue to provide input on study procedures and materials and contribute to plans for sharing the findings. Sharing the study findings We will share the findings with public, health professionals, researchers and policymakers through plain English summaries, social media, policy briefing documents, scientific papers, conferences and other meetings.
NCT07489352
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.
NCT07487233
Background: Prolonged Grief Disorder (PGD) is a psychiatric diagnosis with significant implications for individuals and society. Familiarity with its diagnostic criteria and recommended interventions is essential for early detection and effective treatment. As aging naturally involves multiple losses, older adults are at distinct risk of developing PGD, a condition associated with psychological and physical comorbidities and increased mortality. In the Israeli context, this issue holds particular significance following the events of October 7, 2023, and the ensuing war, which have had - and continue to have - a profound impact on the population's mental health. Given PGD's recent inclusion in diagnostic manuals, many physicians may lack sufficient knowledge, leading to under-recognition or misdiagnosis. This gap is particularly evident among older adults, for whom the assessment and management of psychological distress are often underassessed and undertreated, highlighting the urgent need for targeted training and broader integration of existing knowledge into clinical practice. Accordingly, the present study has two main objectives: (1) to assess physicians' knowledge and use of PGD diagnostic criteria with older patients, and (2) to evaluate the effectiveness of a brief informational intervention on their understanding and diagnostic application. Methods: Using a mixed experimental design, the study will include senior physicians and residents specializing in geriatrics, psychiatry, and family medicine. Data will be collected via an online structured questionnaire containing professional background items and clinical vignettes designed to assess participants' knowledge and application of PGD diagnostic criteria. Afterwards, participants will be individually randomized (1:1) via a computer-generated sequence in a partially participant-blinded, assessor-blinded controlled trial to either an experimental group viewing an informational PGD video or a control group viewing a structurally equivalent video (matched in length, graphics, and word count) addressing bereavement in older adults without directly referencing PGD. All participants will then complete the vignettes again to evaluate the effects of the intervention. Discussion: This first systematic Israeli study on PGD implementation will provide an empirical basis for policy development, professional training, and prevention programs. Its findings may enhance diagnostic accuracy, improve care efficiency, reduce systemic costs, and support ongoing evaluation and refinement of clinical practices.
NCT07315789
Sarcopenia is one of the main problems in the elderly population. The concept of disease has evolved, as have its treatment strategies. Among these is high-intensity interval training (HIIT). This approach has been little studied in older adults with sarcopenia, especially in institutionalized older adults in nursing homes. So this will be the objective of the study. A randomised clinical trial is being conducted to analyse how these diagnostic criteria for sarcopenia evolve after the application of HIIT compared to a control group.
NCT07472530
Purpose: This study evaluated the impact of a structured intervention on frailty, lung function, physical capacity, and dyspnea in elderly COPD patients. COPD, common in older adults, often coexists with frailty, which worsens health outcomes. While pulmonary rehabilitation improves function, its effect on frailty remains unclear. Procedures: A total of 66 patients with a confirmed diagnosis of COPD were randomly allocated into two equal groups: an intervention group (n=33) and a control group (n=33). Participants in the intervention group completed a six-week pulmonary rehabilitation program. Both baseline and post-intervention evaluations comprised spirometric measurements (FVC, FEV1, FEV1/FVC ratio, FEF25-75, and PEF), the Edmonton Frailty Scale (EFS), the six-minute walk test (6MWT), oxygen saturation levels, and assessments of dyspnea severity. Results: Significant improvements were observed in the intervention group in FVC, FEV1, FEV1/FVC, and PEF (p\<0.05). Total EFS scores and subdimensions such as mood, general health, and cognitive status also improved significantly (p\<0.05). Additionally, the intervention group showed increased 6MWT distance, higher oxygen saturation, and reduced dyspnea scores post-intervention (p\<0.05), with minimal changes in the control group. Conclusion: The findings suggest that pulmonary rehabilitation not only enhances pulmonary function and exercise capacity but also reduces frailty severity in elderly COPD patients. Integrating frailty-focused strategies into routine COPD management may improve outcomes and quality of life in this population.
NCT07123298
In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and/or loneliness. These two home-based care programs may improve each other and provide opportunity to further improve quality of life for people living with disabilities and the caregivers. The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care.
NCT06073990
This study aims to investigate whether a four-week BBTi program can effectively improve chronic insomnia and reduce overall stress in middle-aged and elderly individuals.
NCT07191613
The goal of this quasi-experimental clinical trial is to evaluate the effects of the "HAPPY GO GO" somatosensory game on physical and mental health in community-dwelling older adults aged 65 years and above living in rural Chiayi County, Taiwan. The main questions it aims to answer are: * Does participation in the somatosensory game improve physical health outcomes (e.g., balance, mobility, functional fitness)? * Does participation improve mental health outcomes (e.g., mood, depressive symptoms)? Researchers will compare an intervention group, which participates in the game-based exercise program, with a control group that does not receive the intervention, to evaluate changes in health status. Participants in the intervention group will take part in structured game-based physical activity sessions over several weeks, designed to promote engagement, improve physical performance, and support psychological well-being.
NCT07065071
The investigators would like to find out if Mentalization-Based Therapy (MBT) is effective for people aged 60+ who struggle in relationships. The study aims to understand whether MBT helps older people to build better relationships and feel better about themselves. There is currently no research with people over 60 and MBT, yet MBT is being offered to the older adult population by NHS trusts throughout the UK without evidence for its effectiveness. As well as developing knowledge about how MBT can help at this point in life, the study aims to improve the quality of care offered. MBT targets mentalization, which is the ability to make sense of one's own and other people's thoughts, feelings, actions and beliefs. Current research suggests that the ability to mentalize changes over the lifespan and may be influenced by many factors, some of which are specific to later life. For example, changes in relationships during later life and biological changes in the brain may impact mentalization systems. The investigators would also like to understand what difficulties MBT may be effective for in later life. The diagnosis of borderline personality disorder (BPD), which MBT was developed to treat, was, until recently, assumed to disappear with age. However, growing evidence suggests that symptoms change, rather than disappear. Given these unknowns, the study will use a Hermeneutic Single-Case Efficacy Design (HSCED). Up to six participants, up to six people who know the participants, and clinicians delivering the MBT interventions will be recruited. Data in the form of questionnaires, self-report and therapy documents will be gathered, and everyone will be interviewed. For each participant, the data will be used to compile both an affirmative (yes, MBT was effective) case, and a sceptic case (no, MBT was not effective). Cases will then be reviewed by an adjudication panel comprising one service user expert by experience, one MBT expert and one expert in another therapeutic modality. For each case, each expert will decide if the affirmative or sceptic case was more likely. Finally, findings will be synthesised and used to draw conclusions about the effectiveness of MBT. The HSCED lends itself to theory-building, as it gathers in-depth data from individuals and facilitates comparison within and between cases. Further, participants' contribution to their own 'rich case record' through change interviews recognises people as taking an active role in their own healing.
NCT07292623
The autonomic nervous system consists of two branches, the sympathetic and the parasympathetic, which must work in balance. Its functioning can be measured indirectly by heart rate variability, which is the time between heartbeats, which is not constant. The more it varies, the greater the role of the parasympathetic branch, and vice versa. However, with age, an imbalance can occur and the parasympathetic branch can play a lesser role, resulting in less heart rate variability (the times between heartbeats become more similar). The aim of this study is to know if electrical stimulation in the ear can improve the balance between the two branches of the autonomic nervous system in older adults, comparing two different locations of application. The main questions to answer are: Does applying electrical stimulation to a specific area of the ear improve the balance of the autonomic nervous system? Does it also help improve hand tremors, balance, concentration, saliva production, and voice quality?