A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care

OBJECTIVES: To examine the feasibility and preliminary effectiveness of (1) combining cognitive training, mind-body physical exercise, and nurse-led risk factor modification (CPR), (2) nurse-led risk factor modification (RFM), and (3) health advice (HA) on reducing cognitive decline among older adults with mild cognitive impairment (MCI). METHODS: It was a 3-arm open-labeled pilot randomized controlled trial in the primary care setting in Hong Kong. Nineteen older adults with MCI were randomized to either CPR (n = 6), RFM (n = 7), or HA (n = 6) for 6 months. The primary outcome was the feasibility of the study. Secondary outcomes included the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), the Montreal Cognitive Assessment Hong Kong version (HK-MoCA), the Clinical Dementia Rating (CDR), the Disability Assessment for Dementia (DAD), quality of life, depression, anxiety, physical activity, health service utilization, and diet. RESULTS: Nineteen out the 98 potential patients were recruited, with a recruitment rate of 19% (95% CI [12–29]%, P = 0.243). The adherence rate of risk factor modification was 89% (95% CI [65–98]%, P = 0.139) for CPR group and 86% (95% CI [63–96]%, P = 0.182) for RFM group. In the CPR group, 53% (95% CI [36–70]%, P = 0.038) of the Tai Chi exercise sessions and 54% (95% CI [37–71]%, P = 0.051) of cognitive sessions were completed. The overall dropout rate was 11% (95% CI [2–34]%, P = 0.456). Significant within group changes were observed in HK-MoCA in RFM (4.50 ± 2.59, P = 0.008), cost of health service utilization in CPR (−4000, quartiles: −6800 to −200, P = 0.043), fish and seafood in HA (−1.10 ± 1.02, P = 0.047), and sugar in HA (2.69 ± 1.80, P = 0.015). Group × time interactions were noted on HK-MoCA favoring the RFM group (P = 0.000), DAD score favoring CPR group (P = 0.027), GAS-20 favoring CPR group (P = 0.026), number of servings of fish and seafood (P = 0.004), and sugar (P < 0.001) ate per day. CONCLUSIONS: In this pilot study, RFM and the multi-domain approach CPR were feasible and had preliminary beneficial effects in older adults with MCI in primary care setting in Hong Kong. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR1800015324).