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

Mild Cognitive Impairment Clinical Trial

Official title:

Dual-Task Zumba Gold for Improving the Cognition of Community-Dwelling Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04788238
• Other study ID #: HSEARS20200717002
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 31, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Philippines	Municipality of Plaridel	Plaridel	Bulacan

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Philippines, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline; 12 weeks; 18 weeks
Primary	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.	Baseline; 12 weeks; 18 weeks
Primary	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.	Baseline; 12 weeks; 18 weeks
Primary	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.	Baseline; 12 weeks; 18 weeks
Primary	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.	Baseline; 12 weeks; 18 weeks
Secondary	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.	Baseline; 12 weeks; 18 weeks
Secondary	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.	Baseline; 12 weeks; 18 weeks
Secondary	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.	Baseline; 12 weeks; 18 weeks
Secondary	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.	Baseline; 12 weeks; 18 weeks
Secondary	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.	Baseline; 12 weeks; 18 weeks
Secondary	Changes in waist circumference (from baseline to 18 weeks follow-up)	Waist circumference will be measured in centimeters via tape measure.	Baseline; 12 weeks; 18 weeks