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Randomized Controlled Trial
. 2019 Jul 12;74(8):1296-1302.
doi: 10.1093/gerona/gly204.

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

Jane A Cauley  1 , Todd M Manini  2 , Laura Lovato  3 , Jennifer Talton  3 , Steven D Anton  2 , Kathryn Domanchuk  4 , Kimberly Kennedy  3 , Cynthia L Stowe  3 , Michael Walkup  3 , Roger A Fielding  5 , Stephen B Kritchevsky  3 , Mary M McDermott  4 , Anne B Newman  1 , Walter T Ambrosius  3 , Marco Pahor  2 ; ENRGISE Investigators
Affiliations
Randomized Controlled Trial

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

Jane A Cauley et al. J Gerontol A Biol Sci Med Sci. .

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.

Keywords: Clinical trials; Functional performance; Inflammation; Mobility impairment; Physical function.

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Figures

Figure 1.
Figure 1.
ENRGISE Pilot Study: screening to randomization funnel.
Figure 2.
Figure 2.
(A) Cumulative number of participants randomized in the ENRGISE Pilot Study. (B) Cumulative number of participants randomized in ω-3 stratum only. (C) Cumulative number of participants randomized in losartan (LO) stratum only. (D) Cumulative number of participants randomized in LO and ω-3 stratum trials.
See this image and copyright information in PMC

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