The IGNITE trial: Participant recruitment lessons prior to SARS-CoV-2

Abstract

Full and diverse participant enrollment is critical to the success and generalizability of all large-scale Phase III trials. Recruitment of sufficient participants is among the most significant challenges for many studies. The novel SARS-CoV-2 coronavirus pandemic has further changed and challenged the landscape for clinical trial execution, including screening and randomization. The Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) study has been designed as the most comprehensive test of aerobic exercise effects on cognition and brain health. Here we assess recruitment into IGNITE prior to the increased infection rates in the United States, and examine new challenges and opportunities for recruitment with a goal of informing the remaining required recruitment as infection containment procedures are lifted. The results may assist the design and implementation of recruitment for future exercise studies, and outline opportunities for study design that are flexible in the face of emerging threats.

Effect of aerobic exercise on amyloid accumulation in preclinical Alzheimer’s: A 1-year randomized controlled trial

“…This severely limits the generalizability of our findings and highlights structural racism and inequity related to clinical trial access. As a result, we have begun assessing the design of our trials and increased our efforts to inclusively design our exercise trials with and for underrepresented communities [ 72 – 75 ]. An additional limitation is the use of self-reported physical activity versus an activity monitor and lack of a treatment fidelity analysis.…”

Recruitment methods and yield rates for a multisite clinical trial exploring risk reduction for Alzheimer's disease (rrAD)

“…20 As with rrAD, the most successful source may be dependent on inclusion/exclusion criteria and clinical trial requirements. 2,14,16 Currently, the field lacks high-quality evidence on the effectiveness of different approaches. 2,[14][15][16]19 Approximately 16% of individuals were excluded because they reported their BP did not meet the study criteria.…”

“…2,14,16 Currently, the field lacks high-quality evidence on the effectiveness of different approaches. 2,[14][15][16]19 Approximately 16% of individuals were excluded because they reported their BP did not meet the study criteria. Another 11% of individuals were too active, and 6.3% did not have a family history of dementia or subjective memory decline.…”

“…Limited information is available on the best means of recruiting older adult participants as such information is often not reported 14,15 . When examined, a variety of sources are often used to recruit participants into exercise and vascular trials, as found for the rrAD trial 2,16 . Previous exercise trials cited a variety of sources, including electronic health records 17 , 18 ,word of mouth 16,17,19 , print and electronic flyer 16,17 , press media 16,17 and promotional events 16,19 .…”

“…There are limited publications on the recruitment of individuals into vascular health trials, with the main sources cited being electronic health records and Medicare/Medicaid records 20 . As with rrAD, the most successful source may be dependent on inclusion/exclusion criteria and clinical trial requirements 2,14,16 . Currently, the field lacks high‐quality evidence on the effectiveness of different approaches 2,14–16,19 …”