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

Rachel R. Deer, Jared Dickinson, Jacques Baillargeon, Steven R. Fisher, Mukaila Raji, Elena Volpi

Research output: Contribution to journalArticle

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 clinical 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: A total of 100 patients admitted to the University of Texas Medical Branch hospital for an acute medical illness were randomized to one of five intervention groups: isocaloric placebo, whey protein supplement, in-home rehabilitation + placebo, in-home rehabilitation + whey protein, or testosterone. Primary outcome measure was the change from baseline in short physical performance battery score at 1 and 4 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. RESULTS: Four weeks post-discharge, the short physical performance battery total score and balance score increased more in active intervention groups than placebo group (p < .05). There were no significant differences in change in body composition or activities of daily living across groups or between active intervention groups and placebo group. 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 all active intervention groups (11%) versus placebo group (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 randomized controlled trials to test the effectiveness of these interventions.

Original languageEnglish (US)
Pages (from-to)1628-1636
Number of pages9
JournalThe journals of gerontology. Series A, Biological sciences and medical sciences
Volume74
Issue number10
DOIs
StatePublished - Sep 15 2019

Fingerprint

Clinical Trials, Phase I
Geriatrics
Hospitalization
Randomized Controlled Trials
Placebos
Rehabilitation
Testosterone
Activities of Daily Living
Body Composition
Satellite Hospitals
Outcome Assessment (Health Care)
Exercise
Safety
Whey Proteins

Keywords

  • Hospitalization
  • Protein
  • Rehabilitation
  • Testosterone

ASJC Scopus subject areas

  • Aging
  • Geriatrics and Gerontology

Cite this

A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients. / Deer, Rachel R.; Dickinson, Jared; Baillargeon, Jacques; Fisher, Steven R.; Raji, Mukaila; Volpi, Elena.

In: The journals of gerontology. Series A, Biological sciences and medical sciences, Vol. 74, No. 10, 15.09.2019, p. 1628-1636.

Research output: Contribution to journalArticle

Deer, Rachel R. ; Dickinson, Jared ; Baillargeon, Jacques ; Fisher, Steven R. ; Raji, Mukaila ; Volpi, Elena. / A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients. In: The journals of gerontology. Series A, Biological sciences and medical sciences. 2019 ; Vol. 74, No. 10. pp. 1628-1636.
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AB - 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 clinical 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: A total of 100 patients admitted to the University of Texas Medical Branch hospital for an acute medical illness were randomized to one of five intervention groups: isocaloric placebo, whey protein supplement, in-home rehabilitation + placebo, in-home rehabilitation + whey protein, or testosterone. Primary outcome measure was the change from baseline in short physical performance battery score at 1 and 4 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. RESULTS: Four weeks post-discharge, the short physical performance battery total score and balance score increased more in active intervention groups than placebo group (p < .05). There were no significant differences in change in body composition or activities of daily living across groups or between active intervention groups and placebo group. 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 all active intervention groups (11%) versus placebo group (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 randomized controlled trials to test the effectiveness of these interventions.

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