Active clinical trials for "Frailty"

The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of early nutritional therapy in regard to effectiveness, safety and costs when applied to the heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the question about overall benefit or harm, but using a physio-pathological mechanistic approach, it also will explore and provide conclusive answers about whether, why, how, and in which patient populations nutritional therapy does and does not works.

The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).

The proportion of the elderly population has increased rapidly worldwide. Frailty is a common geriatric syndrome. Comprehensive dietary management strategy may have beneficial effects on frailty prevention and reversal. We compared the effects between micronutrients and/or protein supplement, and balanced diet on frailty status in elderly individuals who were at either pre-frail or frail stage. A total of 37 subjects completed a 3-month paralleled, single-blind, randomized control trial on (1) multiple nutrients supplementations, (2) multiple nutrients plus isolated soy protein supplementation, and (3) individualized nutrition education with designed dishware for balanced diet as well as food supplementations (mixed nuts and milk powder). Intervention effects on dietary intakes, biomarkers, frailty score and geriatric depression score (GDS) were assessed. The nutrition education intervention with designed dishware and milk powder/nuts supplement significantly increased the intake of vegetables, dairy, and nuts, along with increased concentration of urinary urea nitrogen of the pre-frail/frail elders. It yielded a significant reduction in frailty score (p<0.05) and a borderline decrease (p=0.063) in GDS-SF. Our study indicated that the dietary approach with easy-to-comprehend dishware and food supplements to optimize the distribution of multiple dietary components showed its potential to improve not only frail status but also psychological condition in elderly.

The main purpose of this study is to establish a frailty automatic evaluation index "AI frailty index" based on artificial intelligence multi-modal non-contact monitoring information analysis. At the same time, the study will explore the correlation between ' AI weakness index ' and perioperative and long-term prognosis and quality of life.

Investigators designed the single-center, prospective real-world based clinical study with the aim of applying the standardized geriatric assessment system IMWG-FS internationally for dynamic frailty assessment of elderly newly diagnosed multiple myeloma(NDMM), guiding therapeutic decision based on their fit/frail status (fit → intensive; frail → mild), to observe their treatment tolerance, treatment related adverse events(TRAE), treatment discontinued(TD), and survival(progression survivaland overall survival).

Introduction: The World Health Organization has launched the INSPIRE-ICOPE-CARE program towards healthy aging. It includes "intrinsic capacity", defined as "the composite of all the physical and mental capacities of an individual", which has a positive value towards prevention, and is constructed by five domains: cognition, vitality/nutrition, sensory, psychology, and mobility. ICOPE App and ICOPE Monitor are applications for the self-assessment and monitoring of intrinsic capacity. Hypothesis: Intrinsic capacity self-assessed by the ICOPE Apps could be associated with the incidence of frailty and health outcomes. ICOPE Apps might support geriatric and primary care during the COVID-19 pandemic and beyond. Objectives: To assess the association between intrinsic capacity measured by the ICOPE Apps at baseline and the incidence of frailty in community-dwelling older adults during 1-year follow-up. Secondarily, to assess the association of intrinsic capacity and pre-frailty, falls, functional decline, institutionalization, and mortality (COVID-19-related/not related). Methods: Protocol for a cohort study of community-dwelling adults ≥65-year-old, with no other exclusion criteria than the inability to use the Apps or communicate by telephone/video-call for any reason (cognitive or limited access to telephone/video-call). Intrinsic capacity measured by the ICOPE Apps and Rockwood's clinical frailty scale will be assessed at baseline, 4-, 8- and 12-month follow-up by telephone/video-call. Assuming a prevalence of frailty of 10.7%, and incidence of 13% (alpha-risk=0.05), 400 participants at 12-month end-point (relative precision=0.10) and 600 participants at baseline will be required. Associations among the decrease in intrinsic capacity, incidence of frailty, and occurrence of health adverse outcomes during 1-year follow-up are expected. ICOPE Apps might identify individuals at higher risk of frailty and health adverse consequences. The implementation of the ICOPE Apps into clinical practice might help to bring the practitioners closer to their patients, deliver efficient person-centered care-plans, and benefit the healthcare systems during the COVID-19 pandemic and beyond.

Exercise in general and resistance training (RT) in particular have demonstrated positive effects on physical functioning and frailty. However, frail older people with functional impairments are among the least physically active and may have problems reaching high intensity levels. The use of special vests with integrated electrodes allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at low subjective effort level. This whole-body electromyostimulation (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail older people. This study aims at investigating the feasibility and safety of WB-EMS in frail older people with functional limitations. To explore the effects of age and functional status, young and robust old reference groups will serve as comparators.

Exercise in general and resistance training (RT) in particular have demonstrated positive effects on frailty outcomes, including physical functioning. However, frail older people with functional impairments are among the least physically active and have problems reaching high-intensity levels. Whole-body electromyostimulation (WB-EMS) allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at a low subjective effort level. The efficacy of WB-EMS in frail older people has yet to be determined. The primary objective of this study is to investigate the efficacy of WB-EMS in frail older people.

Introduction. Although ageing is a general phenomenon, a great inter individual variability on the quality of ageing can be observed. This substantial heterogeneity may be partly explained by extrinsic factors such as lifestyle, habits, physical activity, diet, which may play an important role in the age-associated declines. The concept of frailty was introduced to account for variability in the aging process. This clinical and biological syndrome reflects a decrease in the physiological reserve, and leads to an insidious, precarious equilibrium that can break down during a stressful life event. In older adults, frailty is known to be associated with an increased risk of adverse outcomes, such as falls, fractures, unplanned hospitalizations, and death. Several frailty domains may only be slightly altered, so that early-stage frailty is not necessarily clinically visible. The most commonly used operational definitions of frailty are based on two different conceptual frameworks. Fried's rules-based criteria correspond to a physical phenotype, whereas the "Rockwood accumulative model" defines frailty as the accumulation of multiple deficits. These tools were built for individuals aged 65 and over. However, frailty can also be found in younger adults. Although the early detection of frailty is potentially important (since the condition might be reversible in its early stages), frailty has not been extensively investigated among middle-aged individuals. Indeed, most of the literature studies have focused on older adults or on a small number of frailty parameters the investigators hypothesized that the factors determining the main ageing-related adverse events are already present in middle age. The main objectives of the SUCCEED cohort are therefore to 1/investigate the prevalence of frailty parameters in community-dwelling individuals aged 50 and over, 2/ assess the parameters' prognostic value for future adverse health events, 3/ investigate frailty classifications in this population and assess the evolution of profiles over time Method. The SUCCEED survey is a French retrospective and prospective cohort that includes community-dwelling individuals aged 50 years or over consecutively attending an outpatient clinic ("successful ageing") in a geriatric teaching hospital in the Paris area, France. Baseline parameters are collected using a self-administered questionnaire followed by an interview, physical measurements, and performance tests conducted by trained nurses, and then a standardized clinical evaluation by a geriatrician. This clinical assessment includes evaluation of autonomy, cognition, mood, balance, mobility, muscle strength, nutrition, comorbidities, continence, sensory functions, bone density, sleeping disorders. Patients who have attended the outpatient clinic from the 01/01/2010 to 14/01/2020 are retrospectively included in the cohort, the other ones are prospectively included.

The use of non-medical cannabidiol (CBD) has been growing recently in France and in the world, in young but also older adults. Few data are available on the use of cannabidiol in older adults. A better knowledge of the use of cannabidiol in older adults, and of their own knowledges of the molecule, is necessary to guide and follow the CBD uptake in this population and avoid potential adverse events.