A study protocol for MindMoves: A lifestyle physical activity and cognitive training intervention to prevent cognitive impairment in older women with cardiovascular disease

Abstract

Introduction: Cognitive impairment (CI) and cardiovascular disease (CVD) disproportionately affect women compared to men, and CVD increases risk of CI. Physical activity and cognitive training can improve cognition in older adults and may have additive or synergistic effects. However, no combined intervention has targeted women with CVD or utilized a sustainable lifestyle approach. The purpose of the trial is to evaluate efficacy of MindMoves, a 24-week multimodal physical activity and cognitive training intervention, on cognition and serum biomarkers in older women with CVD. Three serum biomarkers (brain-derived neurotrophic factor [BDNF], vascular endothelial growth factor [VEGF], and insulin-like growth factor 1 [IGF-1]) were selected as a priori hypothesized indicators of the effects of physical activity and/or cognitive training on cognition.

Methods: The study design is a randomized controlled trial with a 2 × 2 factorial design, to determine independent and combined efficacies of Mind (tablet-based cognitive training) and Move (lifestyle physical activity with goal-setting and group meetings) on change in cognition (primary outcome) and serum biomarkers (secondary outcomes). We will recruit 254 women aged ≥65 years with CVD and without CI from cardiology clinics. Women will be randomized to one of four conditions: (1) Mind, (2) Move, (3) MindMoves, or (4) usual care. Data will be obtained from participants at baseline, 24, 48, and 72 weeks.

Discussion: This study will test efficacy of a lifestyle-focused intervention to prevent or delay cognitive impairment in older women with CVD and may identify relevant serum biomarkers that could be used as early indicators of intervention response.