Design, Setting, and Sample

Our intervention is grounded in the Health Belief Model and Social Learning Theory, which posits that a health care intervention is more likely to influence behavior change if it includes the following components in its implementation: knowledge, self-efficacy, ability/skills, and environment (Rosenstock et al., 1988). We believe that our intervention program incorporates all of these elements and guides the study toward successful behavior change. The study is designed as a randomized, controlled trial investigating feasibility and effect size (Supplemental Digital content). There will be two groups; participants will be randomized to a 24-week walking program or a usual care group. Thirty-four older adults with moderate to severe CKD (defined as an estimated glomerular filtration rate [eGFR]) < 60ml/min/1.73m²-15 ml/min/1.73m²) will be enrolled in the 24-week program: 17 in the moderate-intensity walking exercise group and 17 in the usual care group. The study population is community-dwelling men and women with CKD, between 60 and 80 years of age, with preclinical cognitive impairment (Jessen et al., 2014). Subjective cognitive complaint will be defined as a participant answering affirmatively to the question, “Do you feel like your memory or thinking skills have gotten worse recently?” The inclusion and exclusion criteria for the study sample are detailed in Table 1. An eligibility checklist will be completed prior to any study participation during the initial phone screen and during the initial visit.

Inclusion and Exclusion Criteria

Note. ICD = International Classification of Diseases

This is a pilot study to determine feasibility and preliminary effect size. It is expected that the data will be utilized to assess effect size and the necessary sample size to detect significant differences between groups. A sample size of 12/group is recommended for pilot studies estimating the mean and variability of continuous outcomes (Moore et al., 2011). The sample size is therefore based on a total sample of 24. We will oversample by 10 participants to ensure that we end the study with an n of 24 or greater. With this in mind, it is anticipated that 17 participants will be randomized to a 6-month, home-based exercise program and 17 participants randomized to the usual care control group. The study was reviewed and approved by the University of Illinois Chicago Institutional Review Board, and the study has been registered at Clinical Trials.gov (NCT# 03197038).