Clinical trial NCT04788238: Dual-Task Zumba Gold for Improving the Cognition of Older Adults With MCI
Official title: Dual-Task Zumba Gold for Improving the Cognition of Community-Dwelling Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: dual-task
Zumba Gold
mild cognitive impairment
dementia risk reduction
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be equally allocated to the intervention and control group, following a randomization schedule generated by an independent statistician who has no access to the subjects. The randomization list will be sealed in sequentially numbered opaque envelopes. Participants will be informed of the group allocation after the submission of written consent and completion of the baseline assessments.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to assess the preliminary efficacy of a Dual-Task Zumba Gold (DTZ) intervention that will support physical and cognitive training among community-dwelling persons with mild cognitive impairment (MCI). A 12-week Dual-Task Zumba Gold (DTZ) intervention will be implemented among 30 participants with MCI in the treatment group, while health education will be provided to another 30 subjects allocated in the control group. Changes in global cognitive function, together with the quality of life, mood, functional mobility, and bodily measures, will be re-assessed after the 12-week intervention and a 6-week follow-up period. Quantitative and qualitative methods will also be employed to assess the feasibility and acceptability outcomes of the study.

Detailed description: Background: Dementia risk reduction is considered a public health priority. However, there is a paucity of related interventions among low- and middle-income countries (LMICs), such as the Philippines, despite the higher number of dementia cases in these regions. Meanwhile, individuals with mild cognitive impairment (MCI), being at risk for dementia, are important targets for interventions to promote cognitive health.

The enrichment of physical activities with cognitive exercises, known as dual-task training, is an innovative approach that has been noted to potentially improve cognitive outcomes in persons with MCI. Zumba is a popular dance worldwide, which combines rhythmic aerobic steps and whole-body movements. It has a modified version for older adults, called Zumba Gold, but information about its effects on older people is limited.

Literature states that ensuring sufficient cognitive load in complex motor activities is important to achieve significant and superior cognitive outcomes. Dual-Task Zumba Gold (DTZ), an intervention combining Zumba Gold and simultaneous cognitive training, and is a novel and inexpensive non-pharmacological intervention that may enhance the cognition of persons at risk for dementia. However, its feasibility and potential efficacy among older people with MCI are unknown.

Objectives of the Study: There are two objectives in this study: (1) To determine the feasibility and acceptability of a Dual-Task Zumba Gold (DTZ) intervention among community-dwelling individuals with MCI. (2) To investigate the preliminary efficacy of the DTZ intervention in improving the cognitive function among the recruited participants with MCI.

Methods: This is a mixed-method pilot study, involving quantitative and qualitative methods to evaluate the study outcomes. The proposed 12-week DTZ intervention will be conducted three times/week for 45-60 minutes among individuals with MCI. Cognitive domains of executive function, visuospatial ability, memory, and complex attention will be stimulated through mental exercises which will be performed concurrently with the dance steps during particular sequences of the Zumba Gold dance.

Sixty participants will be recruited, and then randomly allocated to treatment (DTZ) and control groups (health education). The feasibility of the intervention will be assessed by participant recruitment and retention rate, adherence rate, and implementation fidelity. Acceptability will be evaluated quantitatively via self-report attitudes towards the intervention. Moreover, qualitative data will be collected via focus group discussions to obtain their feedback toward the intervention.

Changes in cognitive function will be assessed as the primary outcomes, to be measured via the following tools: Montreal Cognitive Assessment (MoCA-P) for global cognition; Trail Making Tests A and B (TMT A \& B) for executive functioning; Digit Span Test (DST) and MoCA-Memory Index Score (MoCA-MIS) for memory. Secondary outcomes to be evaluated include quality of life (Perceived Well-being Scale), mood (Geriatric Depression Scale-Short Form), functional mobility (Short Physical Performance Battery), and bodily measures (blood pressure, body mass index, and waist circumference).

Content analysis will be utilized to analyze qualitative data from the interviews. Meanwhile, descriptive statistics, Chi-square test, and independent t-test will be used to analyze the subjects' characteristics and compare the two groups at baseline. Generalized estimating equations (GEE) will be used to determine the intervention's preliminary efficacy at the post-treatment period.

Eligibility criteria: Inclusion Criteria:

* subjective report/concern about changes in memory or cognition
* objective cognitive impairment, based on Montreal Cognitive Assessment (MoCA) score of ≤25
* absence of diagnosis of dementia or Alzheimer's disease
* normal function in daily activities, via Katz ADL scale score of 6
* ambulatory, without the need to use assistive devices
* able to read/communicate in the Filipino/English language

Exclusion Criteria:

* medical diagnosis of any form of neurological or psychiatric disorder
* uncontrolled or severe heart condition, cancer, major musculoskeletal disorder, psychiatric condition, serious hearing/visual impairment, or any condition that would limit study safety; or being at risk for adverse events to PA participation, assessed via the revised Physical Activity Readiness Questionnaire (rPARQ)
* intake of medications such as anti-depressants, sedatives, or anti-epileptics that may affect cognition
* participation in any organized physical activity program in the past 3 months

Primary outcomes:
measure: Changes in Montreal Cognitive Assessment score (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in Trail Making Test Part A (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in Trail Making Test Part B (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in Digit Span test (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in the MoCA-Memory Index score (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
Secondary outcomes:
measure: Changes in quality of life using Perceived Well-Being Scale (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in mood using Geriatric Depression Scale-Short Form (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in functional mobility using Short Physical Performance Battery (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in blood pressure (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in body-mass index (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
measure: Changes in waist circumference (from baseline to 18 weeks follow-up)
timeFrame: Baseline; 12 weeks; 18 weeks
Other outcomes:
Locations:
city: Plaridel
country: Philippines
facility: Municipality of Plaridel
state: Bulacan
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Angela Leung, PhD
role: PRINCIPAL_INVESTIGATOR
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