Effect of aerobic exercise combined with meditation on cognitive frailty: study protocol for a parallel group randomised controlled trial.

This registered clinical trial protocol describes a four-arm, assessor-blind randomized controlled trial that will test whether combining aerobic exercise with meditation produces greater improvements in physical and cognitive function for people with cognitive frailty than either practice alone. Cognitive frailty is the simultaneous presence of physical frailty and cognitive impairment without dementia. One hundred forty qualified participants will be randomly assigned to aerobic exercise, meditation, combined aerobic exercise and meditation, or a health education control group for 12 weeks. Primary outcome is the Edmonton Frailty Scale; secondary outcomes include cognitive tests, physical performance, subjective experiences, brain MRI measures, and blood biomarkers. Assessments occur at baseline and after the intervention.

Study at a glance

Abstract

Cognitive frailty (CF) is a clinical syndrome characterised by the concurrent occurrence of physical frailty and cognitive impairment, excluding Alzheimer's disease and other forms of dementia. Recent studies have shown that combining aerobic exercise (AE) and meditation (ME) effectively enhances both physical and cognitive functions in individuals with CF. The study aims to determine whether the combined application of AE and ME can elicit significantly greater improvements in physical and cognitive functions among individuals with CF compared with the independent practice of either AE or ME alone. The research design employs a four-arm, assessor-blind randomised controlled trial. A total of 140 qualified subjects will be randomly allocated among four groups: AE, ME, AE combined with ME and a health education control group, ensuring equivalent distribution across groups. The intervention phase of the study will last for 12 weeks. The primary outcomes will include the Edmonton Frailty Scale, while secondary outcomes will encompass evaluations of cognitive functions (including global cognitive function, memory, attention, executive function and visuospatial abilities), physical performance (measured by gait speed and lower extremity strength), subjective experiences (such as fatigue, quality of life, mindfulness, mood and sleep quality), as well as structural and functional MRI assessments and serum biomarkers. Outcomes will be evaluated at baseline and following the 12-week intervention. The Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine granted ethical approval for the study (2023KY-012-02). The findings will be disseminated through publications in peer-reviewed journals and presentations at academic conferences. ChiCTR2300073563.