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J Gerontol A Biol Sci Med Sci. 2019 Mar 25. pii: glz084. doi: 10.1093/gerona/glz084. [Epub ahead of print]

A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients.

Author information

1
Sealy Center on Aging, The University of Texas Medical Branch. Galveston, TX.
2
Division of Rehabilitation Sciences, The University of Texas Medical Branch. Galveston, TX.
3
School of Nutrition and Health Promotion, Healthy Lifestyles Research Center, Arizona State University. Phoenix, AZ.
4
Dept. of Preventive Medicine and Community Health, The University of Texas Medical Branch. Galveston, TX.
5
Dept. of Physical Therapy, The University of Texas Medical Branch. Galveston, TX.
6
Dept. of Internal Medicine, Division of Geriatrics, The University of Texas Medical Branch. Galveston, TX.

Abstract

BACKGROUND:

Physical function declines during hospitalization in geriatric patients, increasing the risk of loss of independence. There is a need for evidence-based, pragmatic interventions to improve functional recovery of older adults following acute hospitalization. Here we report the results of a Phase I randomized controlled trial designed to determine safety and effect size of protein supplementation, exercise, and testosterone interventions on 30-day post-discharge functional recovery and readmissions in geriatric patients.

METHODS:

100 patients admitted to the UTMB hospital for an acute medical illness were randomized to one of five intervention groups: isocaloric placebo, whey protein supplement, in-home rehabilitation+placebo, rehabilitation+whey protein, or testosterone. Primary outcome measure was the change from baseline in Short Physical Performance Battery (SPPB) score at one and four weeks post-discharge. Secondary outcomes were changes in body composition, activities of daily living, and 30-day readmissions. Comparisons were made across study groups and between placebo and all active intervention groups (AIG).

RESULTS:

Four weeks post-discharge the SPPB total score, and balance score increased more in AIG than placebo (P<0.05). There were no significant differences in change in body composition or activities of daily living across groups, or between AIG and placebo. Readmission rates were highest in placebo (28%), followed by rehabilitation+placebo (15%), whey protein (12%), rehabilitation+whey protein (11%), and testosterone (5%). There was a trend for lower readmission rates in AIG (11%) vs. placebo (28%).

CONCLUSIONS:

Findings from this Phase I clinical trial suggest that pragmatic, evidence-based interventions may accelerate recovery from acute hospitalization in geriatric patients. These data provide essential information to design larger RCTs to test the effectiveness of these interventions.

KEYWORDS:

Hospitalization; Protein; Rehabilitation; Testosterone

PMID:
30906944
DOI:
10.1093/gerona/glz084

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