The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.

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.

• Authors: 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, ENRGISE Investigators
• Journal: The journals of gerontology. Series A, Biological sciences and medical sciences (J Gerontol A Biol Sci Med Sci) Vol. 74 Issue 8 Pg. 1296-1302 (07 12 2019) ISSN: 1758-535X [Electronic] United States
• PMID: 30202946 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, Non-P.H.S.)
• Copyright: © The Author(s) 2018. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• Angiotensin-Converting Enzyme Inhibitors
• Fatty Acids, Omega-3
• Interleukin-6
• Losartan

Topics

• Aged
• Angiotensin-Converting Enzyme Inhibitors (therapeutic use)
• Fatty Acids, Omega-3 (therapeutic use)
• Feasibility Studies
• Female
• Humans
• Inflammation (prevention & control)
• Interleukin-6 (blood)
• Losartan (therapeutic use)
• Male
• Mobility Limitation
• Pilot Projects
• United States
• Walking Speed