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

NCT04301544 | Completed

• 2 other identifiers: CT-18146PITAHC-IDxxx
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mild Cognitive Impairment (MCI); Multicomponent intervention; Dance; Vascular risk factors

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Score

  To measure the cognitive function in Alzheimer's disease (AD), hence its popularity for use in cognitive testing of the effects of AD treatment in clinical trials. It consists of 11 tasks measuring the core cognitive deficits of AD, such as disturbances of memory, language, praxis, attention, visuospatial function and other cognitive abilities. ADAS-Cog was validated for use in the Filipino elderly with age and education stratified norms. Score ranges from 0 to 70 points, with lower scores indicating better cognitive functions.

  At 6th month and 12th month of intervention

• Change from baseline in Mnemonic Similarity Task score

  This task place strong demands on pattern separation, memory representation and measures cognitive domains highly correlated with hippocampal function. Pre-MST use set 1, self-paced timing, consisting two phases: encoding and test part. The encoding phase presents 128 colored photographs of objects on computer screen (2 secs duration; ≥ 0.5 secs inter-stimulus-interval/ISI) to be classified by participants as either indoor (key "V") or outdoor (key "N"). The test phase consists of 192 items (64 repeated items, 64 lure items and 64 foil items; presented 2 secs, ≥ 0.5 secs ISI), in which participants engaged in a modified recognition task identifying each item as Old (key "V"), Similar (key "B") or New (key "N"). Percentage accuracy is calculated, with higher percentage indicating better functions.

  At 6th month and 12th month of intervention

• Change from baseline in Executive Function Composite score

  To evaluate fluency, attention, visual scanning, processing and psychomotor speed.

  At 6th month and 12th month of intervention

Secondary Outcomes (4)

• Change from baseline in Magnetic Resonance Imaging (MRI)

  At 12th month of intervention

• Change from baseline in Brief Geriatric Depression Scale (GDS) score

  At 6th month and 12th month of intervention

• Change from baseline in Change in EuroQoL - Visual Analog Scale (EQVAS) rating

  At 6th month and 12th month of intervention

• Change from baseline in Change in Berg Balance Scale (BBS) score

  At 6th month and 12th month of intervention

Other Outcomes (1)

• Compliance

  At 6th and 12th month of intervention

Study Arms (2)

INDAK & Standardized Vascular Care Group

EXPERIMENTAL

The experimental arm will receive training on the ballroom dance modules called INDAK (Improving Neurocognition through Dance and Kinesthetics), nutrition counseling and vascular risk management

Behavioral: INDAK (Improving Neurocognition through Dance and Kinesthetics); Behavioral: Nutrition Counseling; Behavioral: Standardized Vascular Care

Standardized Vascular Care Group

ACTIVE COMPARATOR

The control group will receive nutrition counseling and vascular risk management

Behavioral: Nutrition Counseling; Behavioral: Standardized Vascular Care

Interventions

INDAK (Improving Neurocognition through Dance and Kinesthetics) BEHAVIORAL

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.

Also known as: INDAK

INDAK & Standardized Vascular Care Group

Nutrition Counseling BEHAVIORAL

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.

INDAK & Standardized Vascular Care Group; Standardized Vascular Care Group

Standardized Vascular Care BEHAVIORAL

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

INDAK & Standardized Vascular Care Group; Standardized Vascular Care Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 60 years old
• Mild cognitive impairment (MCI) based on Petersen criteria
• Standardized cognitive test ≥1.5 standard deviation (SD) below norms
• Do not fulfill DSM-V criteria for major cognitive disorders
• Clinical Dementia Rating (CDR) of 0.5

You may not qualify if:

• Significant functional impairment based on Lawton's IADL
• Significant neuropsychiatric impairment based on NPI-Q
• Significant hearing and visual impairment that limit testing and dance participation
• Pre-existing illness that in the judgment of the study physician precludes engagement in moderate physical activity

Sponsors & Collaborators

• St. Luke's Medical Center, Philippines: lead
• Nanyang Technological University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Institute for Neurosciences, St. Luke's Medical Center

Quezon City, National Capital Region, 1102, Philippines

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jacqueline C Dominguez, MD

  St. Luke's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Memory Center

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: March 10, 2020
• Study Start: May 28, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

PH (1)