View clinical trials related to Physical Frailty.
Filter by:Prevention of physical disability represents a major priority for the public health system. Physical disability is the final result of a complex cascade of negative events occurring at different levels (i.e., environmental, social, biological, and clinical). The heterogeneity of the underlying mechanisms responsible for the onset of physical disability may require the adoption of preventive interventions affecting multiple domains. Although several studies suggest that single or different combinations of preventive interventions (in particular, physical activity, cognitive training, and healthy diet) might provide beneficial effects in preventing functional loss (and its related features, such as pain or reduced quality of life), very limited evidence coming from clinical trials is currently available on the topic. Intervention trials are usually designed to test the effect of a specific monodimensional intervention on a very selected population, so to reduce the risk of biased results. This approach, although legitimate and methodologically correct, may 1) be insufficient to target the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical disability, and 2) cause a population selection bias leading to difficulties in implementing the study results to the overall older population (thus, determining the "evidence-based medicine" issue in the elderly). To our knowledge, there are no available data from clinical trials evaluating the effects of a multidomain intervention based on lifestyle modifications (e.g., physical activity, cognitive training, nutritional modification) for preventing mobility disability (a very early phase of the disabling process) in community-dwelling older persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain person-tailored preventive intervention (based on physical activity, cognitive training, and nutritional modifications) on frailty status, physical performance, cognitive function, nutritional status, health-related quality of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the proposed intervention. The project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial. By providing a conclusive answer about the effectiveness of a multidimensional preventive program in the primary prevention of major health-related outcomes, the results of the full-scale trial will have relevant clinical and public health implications, and will promote the practicing of a truly evidence-based geriatric medicine.
The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.
Background: - The island of Sardinia, an Italian region, has a population that is highly interrelated. Researchers have developed the SardiNIA longitudinal study to examine the possible genetic factors that predispose individuals to diseases and to various inherited conditions. In the study, participants will be drawn from four towns in the Ogliastra region (Lanusei, Ilbono, Elini, and Arzana), and their DNA will be analyzed and compared with a long-term assessment of various health-related events. The SardiNIA study is designed to improve understanding of the genetic factors involved in age-associated diseases and disorders, and provide possible points of intervention that may help prevent diseases. Objectives: - To conduct a long-term study of genetics and epidemiology in a small and highly interrelated population. Eligibility: - Individuals at least 18 years of age (at least 14 years of age for Phase 1 of the study) who live in the province of Ogliastra in eastern Sardinia. Design: - This 10-year study will involve three phases: collecting initial blood samples and medical history (years 1 to 4), and two sets of follow-up visits to collect additional data (3 years apart). - Participants will provide detailed medical history and information for long-term study, primarily involving the following aspects: - Demographic/family and clinical variables (e.g., medications, fertility, hospitalizations and surgical procedures, age of relatives who are still alive, age and cause of death in deceased relatives) (Phase 1) - Complete physical examination, including measures of height and weight, blood pressure, and basic heart function (Phase 1) - Blood and urine samples (Phase 1) - Heart and lung function tests (Phase 1) - Assessment of general personality traits and possible history of depression (Phase 1) - Dietary assessment through a food frequency questionnaire (Phase 1) - Cognitive tests of attention, memory, and concentration (Phases 1 and 2) - Frailty-related tests (e.g., hand grip strength, walking speed, bone strength) (Phases 1 and 2) - Eye examination to test for evidence of disease or macular degeneration (Phases 1 and 2) - Kidney and thyroid ultrasound (Phases 1, 2, and 3)