Effects of multidomain intervention on cognitive function in older adults with cognitive impairment: A multicenter, four‐arm, cluster randomized trial

Abstract INTRODUCTION Multidomain lifestyle‐based interventions seem to be effective for cognitive improvement but larger trials are limited, especially in China. This study aims to explore whether multi‐domain interventions of Baduanjin exercise, the Mediterranean‐DASH Intervention for Neurodegenerative Delay (MIND) diet, and relaxation training can improve cognitive function in older adults. METHODS This is a four‐arm cluster randomized trial conducted in 15 centers (counties/districts) in China. A total of 60 communities with 886 older adults with cognitive impairment were randomized to the control group (routine service, RS), and groups B (Baduanjin exercise, plus RS), BM (Baduanjin exercise and MIND diet, plus RS), and BMR (Baduanjin exercise, MIND diet, and relaxation training, plus RS), in a 1:1:1:1 ratio. The intervention lasted for 9 months. The two primary outcomes were an executive function composite and a global cognitive function composite; the secondary outcomes were Mini‐Mental State Examination (MMSE) score and six individual tests that comprise the global cognitive function composite. RESULTS Among 886 old adults with cognitive impairment at baseline, 801 and 809 participants were followed for 4.5 months and 9 months, respectively. At the 9‐month follow‐up, the BMR and BM interventions showed significant effects on executive function (Mean difference in change of composite for BMR vs. Control: 0.26 points 95% CI, 0.11, 0.41, p < 0.001; BM vs. Control: 0.23 points 95% CI, 0.08, 0.37, p = 0.003); however, only BMR demonstrated significant effects on global cognitive function (BMR vs. Control: 0.22 95% CI, 0.09, 0.35, p = 0.001; BM vs. Control: 0.17 95% CI, 0.04, 0.30, p = 0.01). No significant effect of Baduanjin alone was observed. CONCLUSION A multi‐domain comprehensive intervention combining Baduanjin exercise, MIND diet and relaxation training, can significantly improve both executive function and global cognitive function after 9 months in older adults with cognitive impairment. These findings supported the use of these interventions to enhance cognitive function in older adults. Trial Registration Chinese clinical registry, registration number: ChiCTR2100045375.