Filipino Multicomponent Intervention to Maintain Cognitive Performance in High Risk Population (FINOMAIN)

Summary

FINOMAIN is a community-based, cluster randomized controlled trial (cRCT) of dance intervention INDAK and standardized vascular care. The study aims to develop and assess the effectiveness of a cost-effective and culturally - fit intervention for Filipino older adults at high risk for developing dementia.

The first objective of the study is to evaluate the efficacy of dance intervention INDAK on cognitive function as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog), Mnemonic Similarity Task (MST), and Executive Function Composite (EFC) among older adults with mild cognitive impairment (MCI). To increase the sensitivity of primary outcome for various composites of cognition, aside from ADAS-Cog that assesses core cognitive deficits of dementia, investigators will develop an executive function composite that will combine measures of executive control using performance outcomes on tests including Trail Making Test (TMT), Digit Symbol Substitution Test (DSST), Verbal Fluency Test (VFT), and Number Cancellation Task (NCT). Executive function composite scores have been used to track aging populations at risk for dementia and are shown to be sensitive in capturing cerebrovascular benefits and used as instruments in studies with similar non-pharmacological intervention (i.e. aerobic exercise, dance). Additionally, the investigators will add MST which is a measure for episodic memory, memory representations and pattern discrimination which are all cognitive domains highly correlated with hippocampal function.

The second objective of the study is to determine the effect of dance on neuroplasticity as measured by brain volumetry and functional connectivity demonstrated through Magnetic Resonance Imaging (MRI) and change in other behavioral and functional outcomes of participants with MCI.

Conditions

• Mild Cognitive Impairment

Interventions

BEHAVIORAL

INDAK (Improving Neurocognition through Dance and Kinesthetics)

INDAK (Improving Neurocognition through DAnce and Kinesthetics) is a structured modular dance consisting of 8 types of ballroom dances (Reggae, Cha-cha, Samba, Merengue, Bachata, Swing, Tango and Salsa) with increasing complexity. The intervention group will receive dance intervention from a dance teacher two times a week, one hour each time, for 12 months. Each 60-minute session has 3 parts: 10 minutes warm-up/ stretching, 40 minutes dance proper and 10 minutes cool down. This dance intervention will last for 12 months.

BEHAVIORAL

Nutrition Counseling

The dietary advice will follow Filipino Nutrition Research Institute (FNRI) recommendation called Pinggang Pinoy or Filipino Plate, which is a picture of a nine-inch plate with foods proportionally distributed among the food groups to provide approximately 1,200 to 1,500 calories per day. It is advised that half of the plate is composed of green leafy vegetables and one serving of fruit per meal. For fruits, 4 to 6 servings are encouraged per day. In general, affordable nutritious food is recommended: high consumption of local fruits and vegetables, brown/purple rice instead of white rice, coconut oil and other vegetable oils, and fish. Participants will be asked to use structured 3-day meal diary for diet monitoring. Individual counseling sessions depending on identified vascular risks based on FNRI recommendations will also be conducted. This is followed-up by study nutritionists every 3-month of intervention period.

BEHAVIORAL

Standardized Vascular Care

The management advice for hypertension, diabetes, and dyslipidemia will be based on Filipino standard clinical practice guidelines. This is followed-up by study physicians every 3-month of intervention period

Sponsors & Collaborators

• Nanyang Technological University

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• St. Luke's Medical Center, Philippines

  lead OTHER

Principal Investigators

• Jacqueline C Dominguez, MD · St. Luke's Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-28

Primary Completion

2020-12-30

Completion

2020-12-30

Countries

• Philippines

Study Locations