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Frailty clinical trials

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NCT ID: NCT06435247 Not yet recruiting - Old Age; Debility Clinical Trials

The Effect of Accompainment by Older Adults on Anesthetic Recovery

AAR
Start date: June 2024
Phase: N/A
Study type: Interventional

Summary: In 2022, Mexico estimated a population of 17,958,707 older adults. With increased life expectancy, it is essential to seek strategies that improve the health of this population, as they are more vulnerable compared to other age groups due to functional and cognitive decline, along with an increase in chronic diseases and medication intake. During this stage of life, there is a possibility of requiring surgical treatment, which is the focus of this protocol proposing a maneuver that impacts patients' health without requiring economic costs. The proposal suggests the accompaniment of older adults by a family member during the immediate post-anesthetic period. Hypothesis: Accompaniment of older adults during the immediate postoperative period improves the quality of anesthetic recovery by 60%. This value is based on a study by Shem, where accompanying older adults prior to anesthetic induction resulted in a 61% reduction in anxiety among older adults. Anesthesiologists have expanded their role in perioperative medicine alongside geriatric medicine services for older surgical patients. An experimental study will be conducted with two randomly divided groups: one group with accompaniment and one group without accompaniment in the recovery area. Both groups will be assessed using different questionnaires: 1. Pfeiffer Test for cognitive impairment diagnosis, 2. QoR-15 to assess the quality of anesthetic recovery, 3. Beck Anxiety Questionnaire, all of which will be administered 24 hours after surgery. Delirium will also be assessed using NuDESC at 24 hours, day 5, and 30 days after surgery. General data prior to surgery will be recorded, and vital signs such as heart rate, blood pressure, and pain on a verbal scale from 0 to 10 will be monitored during the postoperative period. Statistical analysis will involve representing baseline characteristics of the population using mean and standard deviation or median and interquartile range, depending on the distribution type. X2 will be used to compare both groups in terms of outcomes. Finally, a multivariate analysis will be conducted using logistic regression to adjust for confounding variables.

NCT ID: NCT06433427 Not yet recruiting - Aging Clinical Trials

Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction

FRAMITO
Start date: May 29, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity, and to identify possible frailty biomarkers correlated with mitochondrial dysfunction. The main questions it aims to answer are: - What is the role of oxidative stress-related mitochondrial dysfunction in frailty, taking into account the interaction with multimorbidity. - What could be the specific biomarkers associated with mitochondrial dysfunction in the assessment of frailty. In order to reach the study goals, we will enroll three categories of older adults: - Non-Frail without Multimorbidity (NFWoM); - Frail with Multimorbidity (FWM); - Frail without Multimorbidity (FWoM). Each individual will undergo an assessment of frailty phenotype and multimorbidity, and the collection of blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). The identification of frailty biomarkers in each group of participants will be performed by combining untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and their subpopulations. Multivariate statistical and machine learning techniques will characterize the three clinical phenotype groups based on molecular data.

NCT ID: NCT06430073 Not yet recruiting - Aging Clinical Trials

Effect of Infections and Global DNA Methylation on Frailty Trajectories in Hospitalized Older Patients (INFRAGEN)

INFRAGEN
Start date: May 20, 2024
Phase:
Study type: Observational

This prospective multicenter study aims at exploring the impact of infections on intra-hospital and 3-month changes in the frailty profile of older inpatients. To understand the complex pathways under the relationship between infections and frailty, this study will evaluate infection-related clinical and biochemical markers of systemic inflammation and genetics/epigenetics markers at ward admission. The interplay between clinical, functional, and genetics/epigenetics factors will be evaluated in a subgroup of patients by testing whether 3-month changes in frailty concur with changes in the genomic DNA markers. This study will help characterize the pathophysiological mechanisms of frailty and identify at-risk conditions that may accelerate its course.

NCT ID: NCT06404970 Not yet recruiting - Frailty Clinical Trials

A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Maintaining functional status, or the ability to perform daily activities, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into patient care has been slow and inconsistent due to the burden posed by current tools. The purpose of the proposed QUERI Partnered Evaluation Initiative is to implement and evaluate a patient-centered, low-burden intervention to improve measurement of functional status in VA primary care settings nationally. The investigators hypothesize that implementing this intervention will increase identification and improve management of functional impairment among older Veterans while providing key data to inform VHA strategic planning related to long-term services and supports.

NCT ID: NCT06393647 Not yet recruiting - Frailty Scale Clinical Trials

Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index

Start date: May 15, 2024
Phase:
Study type: Observational [Patient Registry]

In the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, CRP, procalcitonin, vitamin D, IL-1, and IL-6 has been investigated (2). In our study, we aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery. By identifying the relationship among these parameters, we believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

NCT ID: NCT06368674 Not yet recruiting - Frailty Clinical Trials

Bridging the Gap: Creating a Continuum of Care

Start date: May 2, 2024
Phase: N/A
Study type: Interventional

Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward. This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need. The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care.

NCT ID: NCT06363942 Not yet recruiting - Frailty Clinical Trials

A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.

NCT ID: NCT06353438 Not yet recruiting - Aging Clinical Trials

Hydraulic Resistance and Older Adults

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are: - Does the use of hydraulic exercise equipment decrease fall risk in older adults? - Does the use of hydraulic exercise equipment improve function in older adults? Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric).

NCT ID: NCT06352099 Not yet recruiting - Clinical trials for Cognitive Impairment

Dietary Supplementation and Cognitive Functions in the Elderly

ESPINS
Start date: May 2024
Phase: N/A
Study type: Interventional

In recent years, globally, there has been a growth in both the size and the proportion of older adults in the world population. The World Health Organization (WHO) has estimated that by 2030, 1 in 6 people will be 60 years of age or older, and that by 2050, the population of older adults will reach 2.1 billion. The population of older adults (over 80 years) will triple to 426 million by 2050. In particular, Italy represents the second country with the oldest population in the world. Age-related evolution is a gradual and continuous process involving a series of physical and cognitive changes, which, however, has no real 'onset' age. In fact, rather than chronological age, the concept of 'elderly' is based on the individual's degree of self-sufficiency and independence. From a biological point of view, ageing is the set of changes at the molecular and cellular level that occur over time and lead to multi-system functional impairment. It is a process directly related to frailty, falls, and disability. An important factor in counteracting frailty is nutritional intake. Humans ingest approximately 500 g of chemical compounds daily through their diet, most of which are components of plants or vegetables in general. In addition to the well-known macronutrients (proteins, fats, and carbohydrates) and micronutrients (minerals and vitamins), the plant world provides other elements, such as phenols, terpenes, terpenoids, alkaloids, purines, pyrimidines, nucleic acids, and steroids, that exert powerful biological activities. These components are generically called phytochemicals. Epidemiological studies have established that diets rich in plant-based foods help prevent many diseases, such as cardiovascular, metabolic, neurovegetative, and inflammatory diseases. Phytochemical compounds are an extremely diverse set of elements that, when taken at significant levels, have a protective effect on human health. These substances exert various biological functions, such as antioxidant activity, modulation of detoxifying enzymes, stimulation of the immune system, reduction of platelet aggregation, modulation of hormone metabolism, reduction of blood pressure, and antibacterial and antiviral activity. Among the phytochemical compounds, flavonoids represent a category of polyfunctional substances with high bioactivity, comprising more than 5000 compounds. They possess biochemical properties of functional interest in the nutritional and therapeutic fields; for example, rutin, diosmin, and hesperidin are present in some pharmaceutical specialties; flavonoids from ginkgo biloba, hawthorn, and red vine are the main components of many phytotherapeutic extracts. Flavonoids have been shown to play an important role in cardioprotection. Furthermore, in neuroprotection, anthocyanin-rich fruits play a protective role against age-related decline in cognitive functions. However, few studies have evaluated the effect of hesperidin and proanthocyanidins on motor, cognitive, and functional aspects in the elderly. Altemor® is a food supplement based on micronized diosmin, hesperidin, and herbal extracts that has an important integrative supporting action in optimising blood microcirculation. The aim of the study is to evaluate the contribution of dietary supplementation with Altemor® on cognitive function, balance, fatigue, and some domains of quality of life in elderly subjects.

NCT ID: NCT06343727 Not yet recruiting - Frailty Clinical Trials

A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are: - To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible. - To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements. - To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.