Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial

Abstract Hospitalization induces functional decline in older adults. Many geriatric patients fail to fully recover physical function after hospitalization, which increases the risk of frailty, disability, dependence, re-hospitalization, and mortality. There is a lack of evidence-based therapies that can be implemented following hospitalization to accelerate functional improvements. The aims of this Phase I clinical trial are to determine 1) the effect size and variability of targeted interventions in accelerating functional recovery from hospitalization and 2) the feasibility of implementing such interventions in community-dwelling older adults. Older patients (≥ 65 years, n = 100) will be recruited from a single site during hospitalization for an acute medical condition. Subjects will be randomized to one of five interventions initiated immediately upon discharge: 1. protein supplementation, 2. in-home rehabilitation plus placebo supplementation, 3. in-home rehabilitation plus protein supplementation, 4. single testosterone injection, or 5. isocaloric placebo supplementation. Testing will occur during hospitalization (baseline) and at 1 and 4 weeks post-discharge. Each testing session will include measures of muscle strength, physical function/performance, body composition, and psychological function. Physical activity levels will be continuously monitored throughout study participation. Feasibility will be determined through collection of the number of eligible, contacted, and enrolled patients; intervention adherence and compliance; and reasons for declining enrollment and study withdrawal. This research will determine the feasibility of post-hospitalization strategies to improve physical function in older adults. These results will also provide a foundation for performing larger, multi-site clinical trials to improve physical function and reduce readmissions in geriatric patents.