Dual-Task Zumba Gold for Improving the Cognition of Older Adults With MCI

NCT ID: NCT04788238

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors and data analysts will be blinded to the group allocation until the whole data analyses are completed. They will also not be involved in any part of the treatment administration. Furthermore, participants will be advised not to disclose their group assignment during data collection.

Study Groups

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Intervention group

Participants in the intervention arm will participate in the dual-task Zumba Gold (DTZ) program. They will be grouped into 10 participants per class.

Group Type EXPERIMENTAL

Dual-Task Zumba Gold

Intervention Type BEHAVIORAL

Dual-Task Zumba Gold is a 12-week program to be conducted thrice weekly for 45-60 minutes. The intervention involves the concurrent performance of cognitive tasks and physical movements during specific parts of the dance. The activity will begin with warm-up and end with cool-down periods, at 5 to 10 minutes each. Orientation training will be done during the warm-up period, by asking questions to participants about time, place, and person. In the actual dance (30 to 40 minutes), the following domains will be trained: executive function (forward and backward serial counting); perceptual-motor ability (performing arm clock positions based on instructions); memory (forward and backward repetition of number/word series), and attention (forward and backward spelling of 3- to 5-letter words). The cool-down period will incorporate memory training by reminding the participants to summarize the activities performed.

Control group

Participants in the control group will receive health education about dementia risk reduction provided by community health nurses.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dual-Task Zumba Gold

Dual-Task Zumba Gold is a 12-week program to be conducted thrice weekly for 45-60 minutes. The intervention involves the concurrent performance of cognitive tasks and physical movements during specific parts of the dance. The activity will begin with warm-up and end with cool-down periods, at 5 to 10 minutes each. Orientation training will be done during the warm-up period, by asking questions to participants about time, place, and person. In the actual dance (30 to 40 minutes), the following domains will be trained: executive function (forward and backward serial counting); perceptual-motor ability (performing arm clock positions based on instructions); memory (forward and backward repetition of number/word series), and attention (forward and backward spelling of 3- to 5-letter words). The cool-down period will incorporate memory training by reminding the participants to summarize the activities performed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Angela Leung

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Leung, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Municipality of Plaridel

Plaridel, Bulacan, Philippines

Site Status

Countries

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Philippines

References

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Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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HSEARS20200717002

Identifier Type: -

Identifier Source: org_study_id

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