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 (≥65years, 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 4weeks 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.

Keywords: Exercise; Geriatrics; Hospitalization; Physical function; Protein; Testosterone.

Conflict of interest statement

COMPETING INTERESTS

The authors declare that they have no competing interests.

Copyright © 2016. Published by Elsevier Inc.

Figures

Figure 1

Schematic representation of the relationship between acute hospitalization, the loss of muscle size and function, post-hospital syndrome (red arrow to left of descriptions), the inability to recover muscle size and function, decreases in independence, and re-hospitalization. We hypothesize that post-hospitalization interventions involving protein supplementation (#1, green), in-home rehabilitation (#2, blue), in-home rehabilitation plus protein supplementation (#3, orange), or a single testosterone injection (#4, purple) will accelerate functional recovery in previously hospitalized older adults relative to control/standard of care (placebo supplementation only).

Figure 2

Schematic of general study design. Subjects will be recruited during an acute hospitalization. Once consented, subjects will be randomized to one of the five groups. Baseline testing will occur in the hospital and follow-up testing will occur 1- and 4-weeks after hospital discharge. Subjects will begin the intervention protocol the day following discharge. ACE, acute care for elders unit; Ex, exercise/rehabilitation session; T, testosterone injection.