Sarcopenia is characterized by low muscle mass, sometimes along with low strength and physical function. Clinical trials to evaluate potential interventions for this problem are faced with a set of challenges common to many conditions of aging, including: (1) a tension between feasibility and external validity; (2) selection of relevant and feasible outcome measures; and (3) the ability to attribute effects to the intervention. This chapter addresses key issues in the design of such trials. We begin with a set of background issues related to muscle mass, muscle strength and aging. Subsequently we address a series of trade-offs to trial design, based on the goals of treatment; target populations, outcome and mechanistic measures, intervention characteristics, trial duration, frequency of observation and the management of adherence, drop-outs, and missing data. We then summarize the status of recent and ongoing trials. Finally, we identify key gaps in knowledge and new research opportunities.
- Muscle mass
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