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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.

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



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.


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).


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%).


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.


Hospitalization; Protein; Rehabilitation; Testosterone


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