Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04301544 |
| Other study ID # |
CT-18146 |
| Secondary ID |
PITAHC-IDxxx |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 28, 2019 |
| Est. completion date |
December 30, 2020 |
Study information
| Verified date |
October 2022 |
| Source |
St. Luke's Medical Center, Philippines |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Follow-up visits will be conducted by the assessment team (i.e. neurologists, psychologists
and nurses) on the 6th and 12th month of the intervention. To ensure blinding, participants
are asked not to discuss any intervention with anyone. At each meeting, the same clinical
data as from the baseline assessments and laboratory tests will be collected as mentioned
above. Neuroimaging will be done 12 months from baseline. After all data are collected and
encoded, data cleaning, processing, and analysis will be done. The following are the methods
for data acquisition, processing, and analysis:
MRI acquisition, processing, and analysis: Participants will be scanned in a 3T MRI scanner
(Philips Achieva) using an 8-channel head coil. The ADNI-3 (http://adni.loni.usc.edu/adni-3/)
recommended imaging protocols will be used to allow data to be comparable with the ADNI
centers and good potential for data sharing on open access platforms. For resting-state fMRI,
participants will be asked to keep their eyes open and fixate on a cross (10 minutes). The
fMRI task: Participants will undergo 2 runs (6 -7 minutes each) of the visual working memory
task. Each cycle consists of 1 block of high-load and 1 block of low-load that had 2 trials
each. Each block is interleaved by a 1.6 seconds interval and block duration of 20 seconds.
There will be 10 cycles in each run adding up to a total of 20 high-load and 20 low-load
trials. Each run lasts 400 seconds.
Voxel-Based Morphometry (VBM8) will be applied for overall brain volumetric analysis with the
high-resolution MPRAGE T1-weighted image acquisition. FMRIB Software Library (FSL) and Tract
Based Spatial Statistics (TBSS) will be applied for diffusion MRI to understand changes in
structural connectivity. The high-resolution MPRAGE scan will also be applied for automated
hippocampal volumetric studies using NeuroQuant. Coronal axial thin T2-weighted and FLAIR
will be used for detecting subcortical and deep white mater hyperintensities (WMH). The fMRI
data will be pre-processed and analyzed using the Statistical Parametric Mapping (SPM12)
software package. All structural and functional images will be re-oriented before the EPI
data is pre-processed using the conventional procedure in three phases.
Statistical Analysis (Neurocognitive and behavioral measures): The primary outcome which is
the change from baseline (ADAS-Cog, MST, and EFC which a composite of Verbal Fluency Test
(VFT), Number Cancellation Task (NCT), Digit Symbol Substitution Task (DSST) and Trail Making
Test (TMT) and the secondary outcomes (neuroimaging: MRI, GDS, EQVAS BBS) will be analyzed in
the intent-to-treat population as well as in the per-protocol population (complete at least
80% of INDAK modules and participate in at least 30 minutes of dance each time). The study
will employ univariate, bivariate, and multivariate statistics. For univariate, descriptive
statistics (mean/SD; frequencies/percentages) will be used to summarize socio-demographic and
other baseline characteristics. The bivariate analyses that examine underlying relationships
between the outcomes and other clinical characteristics are the following: t-test for
continuous variables and Chi-square test (or Fisher Exact Test when 20 of the cells have the
expected count less than five) for categorical variables to compare baseline data and outcome
measures at baseline between the intervention and control groups. For multivariate analyses,
the study would estimate the effect from baseline to follow-up at 12 months between
randomization groups. Since the participants will be measured 3 times (baseline, 6 months, 12
months), the study will be using the repeated measures analysis of covariance (RM ANCOVA) to
test the significance between group means but controlling for possible confounders. To
analyze for the secondary outcomes, the power will be calculated retrospectively to see if
the sample size is big enough to prove statistical significance. Assuming that enough power
is yielded, repeated measures ANCOVA will also be used.
The end of study analysis will be done for three months and the final report will be prepared
for three months to answer the aims of the study on how multicomponent intervention
significantly maintains or improve cognition of older adults with MCI as measured by primary
outcomes and how the intervention affects neural plasticity and functional connectivity as
measured by MRI after 12 months of the study period.
