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- Title
The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.
- Authors
Cauley, Jane A; Manini, Todd M; Lovato, Laura; Talton, Jennifer; Anton, Steven D; Domanchuk, Kathryn; Kennedy, Kimberly; Stowe, Cynthia L; Walkup, Michael; Fielding, Roger A; Kritchevsky, Stephen B; McDermott, Mary M; Newman, Anne B; Ambrosius, Walter T; Pahor, Marco; Investigators, ENRGISE; ENRGISE Investigators
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>Eligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment.<bold>Results: </bold>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.<bold>Conclusion: </bold>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.
- Subjects
ACE inhibitors; ANGIOTENSIN receptors; PILOT projects; WALKING speed; FISH oils
- Publication
Journals of Gerontology Series A: Biological Sciences & Medical Sciences, 2019, Vol 74, Issue 8, p1296
- ISSN
1079-5006
- Publication type
journal article
- DOI
10.1093/gerona/gly204