Dual-Task Zumba Gold for Improving the Cognition of Older Adults With MCI
Primary Purpose
Mild Cognitive Impairment
Status
Active
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Dual-Task Zumba Gold
Sponsored by

About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring dual-task, Zumba Gold, mild cognitive impairment, dementia risk reduction
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
Sites / Locations
- Municipality of Plaridel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Participants in the intervention arm will participate in the dual-task Zumba Gold (DTZ) program. They will be grouped into 10 participants per class.
Participants in the control group will receive health education about dementia risk reduction provided by community health nurses.
Outcomes
Primary Outcome Measures
Changes in Montreal Cognitive Assessment score (from baseline to 18 weeks follow-up)
Montreal Cognitive Assessment (MoCA) evaluates global cognition by involving multiple domains such as attention, memory, language, visuospatial skills, abstraction, calculation, and orientation. The scores range from 0 to 30, with higher scores indicating better cognitive performance.
Changes in Trail Making Test Part A (from baseline to 18 weeks follow-up)
Trail Making Test Part A is a time-based examination that requires individuals to connect randomly arranged numbers following the correct sequence. The time limit for this test is up to 150 seconds, and shorter duration pertains to better processing speed.
Changes in Trail Making Test Part B (from baseline to 18 weeks follow-up)
Trail Making Test Part B is a time-based examination that requires individuals to connect randomly arranged numbers and letters following the correct and alternating sequence. The time limit for this test is up to 300 seconds, and shorter duration pertains to better executive function.
Changes in Digit Span test (from baseline to 18 weeks follow-up)
In Digit Span Test, numbers are read to the participant at a rate of one per second and then later asked to repeat them in a forward and backward manner. Scores range from 0 - 14 and higher scores indicate better short-term memory.
Changes in the MoCA-Memory Index score (from baseline to 18 weeks follow-up)
The Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS) ranges from 0-15, which is based on free delayed recall, category cued recall, and multiple choice cued recall. Higher scores indicate better delayed recall ability.
Secondary Outcome Measures
Changes in quality of life using Perceived Well-Being Scale (from baseline to 18 weeks follow-up)
The Perceived Well-Being Scale (PWB) assesses older adults' quality of life in the physical and psychological domains, using a 14-item tool with a 7-point Likert scale. Its scores range from 14-98, and higher values pertain to higher quality of life.
Changes in mood using Geriatric Depression Scale-Short Form (from baseline to 18 weeks follow-up)
The Geriatric Depression Scale-Short Form (GDS-SF) is a 15-item instrument which is answered dichotomously by 'yes' or 'no' responses. Scores range from 0-15, with lower scores pertaining to better emotional status.
Changes in functional mobility using Short Physical Performance Battery (from baseline to 18 weeks follow-up)
The Short Physical Performance Battery (SPPB) measures timed performance on three tasks (standing balance, gait speed, and rising from a chair) to derive a score from 0-12. Higher scores indicate better functional mobility.
Changes in blood pressure (from baseline to 18 weeks follow-up)
Blood pressure will reflect systolic and diastolic measures, and will be assessed through calibrated blood pressure monitors.
Changes in body-mass index (from baseline to 18 weeks follow-up)
Body mass index will be reported in kg/m^2, by obtaining the participants' weight (in kilograms) and height (in meters) via a Detecto scale.
Changes in waist circumference (from baseline to 18 weeks follow-up)
Waist circumference will be measured in centimeters via tape measure.
Full Information
NCT ID
NCT04788238
First Posted
February 25, 2021
Last Updated
January 21, 2022
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04788238
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
dual-task, Zumba Gold, mild cognitive impairment, dementia risk reduction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in the intervention arm will participate in the dual-task Zumba Gold (DTZ) program. They will be grouped into 10 participants per class.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive health education about dementia risk reduction provided by community health nurses.
Intervention Type
Behavioral
Intervention Name(s)
Dual-Task Zumba Gold
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Montreal Cognitive Assessment score (from baseline to 18 weeks follow-up)
Description
Montreal Cognitive Assessment (MoCA) evaluates global cognition by involving multiple domains such as attention, memory, language, visuospatial skills, abstraction, calculation, and orientation. The scores range from 0 to 30, with higher scores indicating better cognitive performance.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in Trail Making Test Part A (from baseline to 18 weeks follow-up)
Description
Trail Making Test Part A is a time-based examination that requires individuals to connect randomly arranged numbers following the correct sequence. The time limit for this test is up to 150 seconds, and shorter duration pertains to better processing speed.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in Trail Making Test Part B (from baseline to 18 weeks follow-up)
Description
Trail Making Test Part B is a time-based examination that requires individuals to connect randomly arranged numbers and letters following the correct and alternating sequence. The time limit for this test is up to 300 seconds, and shorter duration pertains to better executive function.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in Digit Span test (from baseline to 18 weeks follow-up)
Description
In Digit Span Test, numbers are read to the participant at a rate of one per second and then later asked to repeat them in a forward and backward manner. Scores range from 0 - 14 and higher scores indicate better short-term memory.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in the MoCA-Memory Index score (from baseline to 18 weeks follow-up)
Description
The Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS) ranges from 0-15, which is based on free delayed recall, category cued recall, and multiple choice cued recall. Higher scores indicate better delayed recall ability.
Time Frame
Baseline; 12 weeks; 18 weeks
Secondary Outcome Measure Information:
Title
Changes in quality of life using Perceived Well-Being Scale (from baseline to 18 weeks follow-up)
Description
The Perceived Well-Being Scale (PWB) assesses older adults' quality of life in the physical and psychological domains, using a 14-item tool with a 7-point Likert scale. Its scores range from 14-98, and higher values pertain to higher quality of life.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in mood using Geriatric Depression Scale-Short Form (from baseline to 18 weeks follow-up)
Description
The Geriatric Depression Scale-Short Form (GDS-SF) is a 15-item instrument which is answered dichotomously by 'yes' or 'no' responses. Scores range from 0-15, with lower scores pertaining to better emotional status.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in functional mobility using Short Physical Performance Battery (from baseline to 18 weeks follow-up)
Description
The Short Physical Performance Battery (SPPB) measures timed performance on three tasks (standing balance, gait speed, and rising from a chair) to derive a score from 0-12. Higher scores indicate better functional mobility.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in blood pressure (from baseline to 18 weeks follow-up)
Description
Blood pressure will reflect systolic and diastolic measures, and will be assessed through calibrated blood pressure monitors.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in body-mass index (from baseline to 18 weeks follow-up)
Description
Body mass index will be reported in kg/m^2, by obtaining the participants' weight (in kilograms) and height (in meters) via a Detecto scale.
Time Frame
Baseline; 12 weeks; 18 weeks
Title
Changes in waist circumference (from baseline to 18 weeks follow-up)
Description
Waist circumference will be measured in centimeters via tape measure.
Time Frame
Baseline; 12 weeks; 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Leung, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Municipality of Plaridel
City
Plaridel
State/Province
Bulacan
ZIP/Postal Code
3004
Country
Philippines
12. IPD Sharing Statement
Plan to Share IPD
No
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Dual-Task Zumba Gold for Improving the Cognition of Older Adults With MCI
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