The enabling reduction of low-grade inflammation in seniors (enrgise) pilot study: Screening methods and recruitment results

Jane A. Cauley*, Todd M. Manini, Laura Lovato, Jennifer Talton, Steven D. Anton, Kathryn Domanchuk, Kimberly Kennedy, Cynthia L. Stowe, Michael Walkup, Roger A. Fielding, Stephen B. Kritchevsky, Mary M. McDermott, Anne B. Newman, Walter T. Ambrosius, Marco Pahor

*Corresponding author for this work

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

Background: The Enabling Reduction of Low-grade Inflammation in Seniors (ENRGISE) Pilot Study is a multicenter randomized clinical trial examining the feasibility of testing whether omega-3 fish oil (ω-3) and the angiotensin receptor blocker losartan alone or in combination can reduce inflammation and improve walking speed in older adults with mobility impairment. We describe recruitment methods and results. Methods: Eligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment. Results: Of those who responded to recruitment, 83% responded to mailings. A total of 5,424 telephone screens were completed; of these, 2,011 (37.1%) were eligible for further screening. The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (n=1.789). Of the 1,305 initial screening visits, 1,087 participants had slow gait speed (<1 m/s). Of these, 701 (64%) had elevated interleukin-6 and were eligible for second screening visits. Of the 582 second screening visits, 335 (57.6%) were eligible to be randomized. A total of 289 participants (96% of goal) were randomized: 180 in the ω-3 stratum (240% of goal); 43 in the losartan (57% of goal), and 66 in the combination (44% of goal). The telephone screen and first screening visit to randomization ratio was 19 to 1 and 4.5 to 1, respectively. The estimated cost of recruitment per randomized participant was $1,782. Conclusion: Recruitment for ω-3 exceeded goals, but goals for the losartan and combination strata were not met due to the high proportion of participants taking angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.

Original languageEnglish (US)
Article numbergly204
Pages (from-to)1296-1302
Number of pages7
JournalJournals of Gerontology - Series A Biological Sciences and Medical Sciences
Volume74
Issue number8
DOIs
StatePublished - Jul 12 2019

Keywords

  • Clinical trials
  • Functional performance
  • Inflammation
  • Mobility impairment
  • Physical function

ASJC Scopus subject areas

  • Aging
  • Geriatrics and Gerontology

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    Cauley, J. A., Manini, T. M., Lovato, L., Talton, J., Anton, S. D., Domanchuk, K., Kennedy, K., Stowe, C. L., Walkup, M., Fielding, R. A., Kritchevsky, S. B., McDermott, M. M., Newman, A. B., Ambrosius, W. T., & Pahor, M. (2019). The enabling reduction of low-grade inflammation in seniors (enrgise) pilot study: Screening methods and recruitment results. Journals of Gerontology - Series A Biological Sciences and Medical Sciences, 74(8), 1296-1302. [gly204]. https://doi.org/10.1093/gerona/gly204