NCT04788238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

February 25, 2021

Last Update Submit

January 21, 2022

Conditions

Keywords

dual-taskZumba Goldmild cognitive impairmentdementia risk reduction

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Changes in quality of life using Perceived Well-Being Scale (from baseline to 18 weeks follow-up)

    Baseline; 12 weeks; 18 weeks

  • Changes in mood using Geriatric Depression Scale-Short Form (from baseline to 18 weeks follow-up)

    Baseline; 12 weeks; 18 weeks

  • Changes in functional mobility using Short Physical Performance Battery (from baseline to 18 weeks follow-up)

    Baseline; 12 weeks; 18 weeks

  • Changes in blood pressure (from baseline to 18 weeks follow-up)

    Baseline; 12 weeks; 18 weeks

  • Changes in body-mass index (from baseline to 18 weeks follow-up)

    Baseline; 12 weeks; 18 weeks

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Dual-Task Zumba Gold

Control group

NO INTERVENTION

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

Interventions

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 group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Municipality of Plaridel

Plaridel, Bulacan, 3004, Philippines

Location

Related Publications (23)

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    PMID: 8778552BACKGROUND
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    PMID: 26749076BACKGROUND
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    PMID: 24088400BACKGROUND
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    PMID: 29973193BACKGROUND
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    PMID: 8126356BACKGROUND
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    PMID: 6418786BACKGROUND
  • Kayama H, Okamoto K, Nishiguchi S, Yamada M, Kuroda T, Aoyama T. Effect of a Kinect-based exercise game on improving executive cognitive performance in community-dwelling elderly: case control study. J Med Internet Res. 2014 Feb 24;16(2):e61. doi: 10.2196/jmir.3108.

    PMID: 24565806BACKGROUND
  • Lauenroth A, Ioannidis AE, Teichmann B. Influence of combined physical and cognitive training on cognition: a systematic review. BMC Geriatr. 2016 Jul 18;16:141. doi: 10.1186/s12877-016-0315-1.

    PMID: 27431673BACKGROUND
  • Luettgen M, Foster C, Doberstein S, Mikat R, Porcari J. Zumba((R)): is the "fitness-party" a good workout? J Sports Sci Med. 2012 Jun 1;11(2):357-8. eCollection 2012. No abstract available.

    PMID: 24137072BACKGROUND
  • McIsaac TL, Lamberg EM, Muratori LM. Building a framework for a dual task taxonomy. Biomed Res Int. 2015;2015:591475. doi: 10.1155/2015/591475. Epub 2015 Apr 19.

    PMID: 25961027BACKGROUND
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    PMID: 25725192BACKGROUND
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    PMID: 15817019BACKGROUND
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    PMID: 24605806BACKGROUND
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    BACKGROUND
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    PMID: 25266297BACKGROUND
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    BACKGROUND
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    BACKGROUND
  • Wechsler DA. Manual for the Wechsler Memory Scale-Revised. New York: Psychological Corporation; 1987.

    BACKGROUND
  • Parial LL, Kor PPK, Sumile EF, Leung AYM. Dual-Task Zumba Gold for Improving the Cognition of People With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial. Gerontologist. 2023 Aug 24;63(7):1248-1261. doi: 10.1093/geront/gnac081.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Angela Leung, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 9, 2021

Study Start

March 29, 2021

Primary Completion

October 15, 2021

Study Completion

August 31, 2022

Last Updated

February 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations