Filipino Multicomponent Intervention to Maintain Cognitive Performance in High Risk Population (FINOMAIN): Integration of Complementary Non-Pharmacological Approach With Standard Medical Care for Elderly With Cognitive Impairment

FINOMAIN is a single-blind (assessor blinded), community-based, cluster randomized controlled trial (cRCT) of a multi-component intervention with two arms. The intervention arm will receive 12 months (1 hour, 2 times per week) of training on the ballroom dance modules called INDAK (Improving Neurocognition through Dance and Kinesthetics), nutrition counseling, and vascular risks management. The control group will receive the same nutrition counseling and vascular risk management except for dance (INDAK).

Study population: In this pilot trial of FINOMAIN, the study aims to enroll at least 72 (20% of total sample size of 328) community-dwelling Filipino older adult participants aged 60 years and above with mild cognitive impairment (MCI) based on Petersen criteria and documented by cognitive symptoms and cognitive performance on the standardized cognitive test (ADAS-Cog) which is ≥ 1.5 standard deviation (SD) below Filipino norms for ADAS-Cog and has a Clinical Dementia Rating (CDR) of 0.5. Participants should not fulfill DSM-V criteria for major neurocognitive disorders. The absence of dementia is further confirmed when there is no functional impairment based on the Lawton's Instrumental Activities of Daily Living (IADL) scale and no significant neuropsychiatric symptoms as detected by the Neuropsychiatric Inventory - Questionnaire (NPI-Q). Exclusion to study are major sensory impairment (i.e. hearing and visual impairment) that limit testing, dance participation and a pre-existing illness that in the judgment of the study physician precludes engagement in moderate physical activity such as INDAK.

The study duration will be 24 months, but the study intervention will last for 12 months. The intervention arm will receive 12 months (1 hour, 2 times per week) of training on the dance modules called INDAK, nutrition counseling and vascular risks management. The control group will receive the same nutrition counseling and vascular risk management except dance (INDAK).

The intervention team consists of research nurses, nutritionists, physicians and dance teachers. The dance intervention INDAK is a structured modular dance consisting of 8 types of ballroom dances with increasing complexity. The INDAK intervention will be done two times a week, one hour each time, for 12 months. The nurse will use a logbook to register the frequency and duration of participation for each participant. From our previous experience, adverse events were infrequently limited to musculoskeletal pains in the first two weeks of study. However, to ensure safety, a trained nurse will always be present at each dance session and liaise with local hospitals in case of unexpected events such as fall, dizziness, or general exhaustion occur. The nurse records the vital signs of all participants before and after the dance.

The nutrition counseling is based on "Pinggang Pinoy" or Filipino plate recommendation of the Filipino Nutrition Research Institute (FNRI) and standardized vascular care for hypertension, diabetes, and dyslipidemia based on Filipino standard guidelines. The nurses will monitor the participants every month and use a logbook to record their compliance and advise participants on a continuing basis. The community physicians and nurses will meet with the participants at 3, 6, and 9 months to monitor their cardiovascular and metabolic conditions and revise their management plan if necessary. If the nurses detect an urgent problem during the monthly monitoring, nurses must alert participants to see the community physicians on an ad-hoc basis. The participants will also be provided with a diary to log their implementation of risk management plans and issues that need to be discussed with the nurses and physicians.