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

J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1296-1302. doi: 10.1093/gerona/gly204.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • 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*

Substances

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