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Randomized Controlled Trial
. 2023 Aug:131:107249.
doi: 10.1016/j.cct.2023.107249. Epub 2023 Jun 1.

Design and baseline characteristics of the Cognitive and Aerobic Resilience for the Brain (CARB) study

Joyce W Tam  1 , Kiran Khurshid  2 , Briana Sprague  3 , Daniel O Clark  3 , Huiping Xu  4 , Lyndsi R Moser  1 , Douglas K Miller  5 , Robert Considine  6 , Christopher M Callahan  6 , Holly J Garringer  5 , Daniel Rexroth  1 , Frederick W Unverzagt  7
Affiliations
Randomized Controlled Trial

Design and baseline characteristics of the Cognitive and Aerobic Resilience for the Brain (CARB) study

Joyce W Tam et al. Contemp Clin Trials. 2023 Aug.

Abstract

Background: Treatments that delay progression of cognitive impairment in older adults are of great public health significance. This manuscript outlines the protocol, recruitment, baseline characteristics, and retention for a randomized controlled trial of cognitive and aerobic physical training to improve cognition in individuals with subjective cognitive dysfunction, the "Cognitive and Aerobic Resilience for the Brain" (CARB) study.

Methods: Community-dwelling, older adults with self-reported memory loss were randomly assigned to receive either computer-based cognitive training, aerobic physical training, combined cognitive and physical training, or education control. Treatment was delivered 2- to 3-times per week in 45- to 90-min sessions for 12 weeks by trained facilitators videoconferencing into subject's home. Outcome assessments of were taken at the baseline, immediately following training, and 3-months after training.

Results: 191 subjects were randomized into the trial (mean age, 75.5 years; 68% female; 20% non-white; mean education, 15.1 years; 30% with 1+ APOE e4 allele). The sample was generally obese, hypertensive, and many were diabetic, while cognition, self-reported mood, and activities of daily living were in the normal range. There was excellent retention throughout the trial. Interventions were completed at high rates, participants found the treatments acceptable and enjoyable, and outcome assessments were completed at high rates.

Conclusions: This study was designed to determine the feasibility of recruiting, intervening, and documenting response to treatment in a population at risk for progressive cognitive decline. Older adults with self-reported memory loss were enrolled in high numbers and were well engaged with the intervention and outcome assessments.

Keywords: Aging; Cognitive function; Cognitive training; Lifestyle intervention; Physical training; Randomized clinical trial; Subjective cognitive decline.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.
Conceptual Model
Figure 2.
Figure 2.
Study Design, Recruitment, Randomization, and Retention
See this image and copyright information in PMC

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