1,721,638 research outputs found

    Frailty and Aging

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    How polypharmacy affects frailty

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    Target population for clinical trials on sarcopenia

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    The term "sarcopenia" describes the progressive decline of muscle mass, strength and function occurring with aging. It is not considered a disease, but the direct consequence of the aging process on the skeletal muscle. Multiple demographic (e.g. gender, race), biological (e.g. inflammatory status) and clinical (e.g. diabetes, metabolic syndrome, congestive heart failure, medications) factors are able to influence (positively or negatively) the skeletal muscle quality and quantity. The extreme paucity of clinical trials on sarcopenia in literature is mainly due to difficulties in designing studies able to isolate the aging process from its multiple and interconnected consequences. In the present review, we present the major factors to consider as potential sources of biased results when evaluating potential candidates for clinical trials on sarcopenia. The development of clinical trials exploring the nature of the sarcopenia process is urgent, but several controversial issues on this hallmark of aging still need clarification

    Designing Phase II B trials in sarcopenia : the best target population

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    Despite the existing limitations and controversies regarding the definition of sarcopenia and its clinical consequences, the current scientific evidence strongly suggests that muscle decline is a primary determinant of the disabling process (and likely of other major health-related events). In fact, the muscle loss (in terms of mass as well as strength) occurring with aging has been growingly associated with mobility impairment and disability in older persons. Unfortunately, current evidence is mainly from observational studies. Times are mature to begin testing interventions aimed at modifying the sarcopenia process through the design and development of specific clinical trials. Considering the emergence of many promising interventions towards this age-related condition (e.g., physical exercise [in particular, resistance training], testosterone, antioxidant supplementations), the need for Phase II trial designs is high. In the present report, we discuss which are the major issues related to the design of Phase II clinical trials on sarcopenia with particular focus on the participant's characteristics to be considered as possible inclusion and exclusion criteria
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